tag:blogger.com,1999:blog-13525850738009310482024-02-08T07:33:14.661-08:00Stock ideas for average investorsStock Ideas for Average investors is about people finding out ideas for stocks that they would potentially invest in. This blog is focused more on the biotechnology side of the industry, however other stock suggestions are more than welcome.amaxhttp://www.blogger.com/profile/08410478051767591573noreply@blogger.comBlogger22125tag:blogger.com,1999:blog-1352585073800931048.post-50113212043666274072014-08-04T05:08:00.000-07:002014-08-04T05:08:25.751-07:00How Contrave May Change The Landscape of Obesity <div dir="ltr" style="text-align: left;" trbidi="on">
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As <strong style="border: 0px; font-family: inherit; font-style: inherit; margin: 0px; padding: 0px;">Orexigen Pharmaceuticals</strong> (<span class="ticker" style="border: 0px; font-family: inherit; font-style: inherit; font-weight: inherit; margin: 0px; padding: 0px;">NASDAQ: <a class="qsAdd qs-source-isssitthv0000001" data-id="210144" href="http://caps.fool.com/Ticker/OREX.aspx?source=isssitthv0000001" style="border: 0px; color: #339933; font-family: inherit; font-style: inherit; font-weight: inherit; margin: 0px; padding: 0px;">OREX</a></span> <a class="addToWatchListIcon qsAdd qs-source-iwlsitbut0000010" href="http://my.fool.com/watchlist/add?ticker=OREX&source=iwlsitbut0000010" style="background-image: url(http://g.foolcdn.com/common/img/buttons/BtnAdd.gif); background-position: 0px 0px; background-repeat: no-repeat; border: 0px; color: #339933; display: inline-block; font-family: inherit; font-style: inherit; font-weight: inherit; height: 16px; margin: 0px; padding: 0px; vertical-align: middle; width: 16px;" title="Add OREX to My Watchlist"> </a>) once again prepares to face the FDA over its weight loss drug Contrave, we must take a look at how this may change the landscape for the weight loss drug market. Adding another competitor is not necessarily good news for the two companies who are already on the market, <strong style="border: 0px; font-family: inherit; font-style: inherit; margin: 0px; padding: 0px;">Vivus </strong> (<span class="ticker" style="border: 0px; font-family: inherit; font-style: inherit; font-weight: inherit; margin: 0px; padding: 0px;">NASDAQ: <a class="qsAdd qs-source-isssitthv0000001" data-id="206768" href="http://caps.fool.com/Ticker/VVUS.aspx?source=isssitthv0000001" style="border: 0px; color: #339933; font-family: inherit; font-style: inherit; font-weight: inherit; margin: 0px; padding: 0px;">VVUS</a></span> <a class="addToWatchListIcon qsAdd qs-source-iwlsitbut0000010" href="http://my.fool.com/watchlist/add?ticker=VVUS&source=iwlsitbut0000010" style="background-image: url(http://g.foolcdn.com/common/img/buttons/BtnAdd.gif); background-position: 0px 0px; background-repeat: no-repeat; border: 0px; color: #339933; display: inline-block; font-family: inherit; font-style: inherit; font-weight: inherit; height: 16px; margin: 0px; padding: 0px; vertical-align: middle; width: 16px;" title="Add VVUS to My Watchlist"> </a>) and<strong style="border: 0px; font-family: inherit; font-style: inherit; margin: 0px; padding: 0px;">Arena Pharmaceuticals</strong> (<span class="ticker" style="border: 0px; font-family: inherit; font-style: inherit; font-weight: inherit; margin: 0px; padding: 0px;">NASDAQ: <a class="qsAdd qs-source-isssitthv0000001" data-id="206618" href="http://caps.fool.com/Ticker/ARNA.aspx?source=isssitthv0000001" style="border: 0px; color: #339933; font-family: inherit; font-style: inherit; font-weight: inherit; margin: 0px; padding: 0px;">ARNA</a></span> <a class="addToWatchListIcon qsAdd qs-source-iwlsitbut0000010" href="http://my.fool.com/watchlist/add?ticker=ARNA&source=iwlsitbut0000010" style="background-image: url(http://g.foolcdn.com/common/img/buttons/BtnAdd.gif); background-position: 0px 0px; background-repeat: no-repeat; border: 0px; color: #339933; display: inline-block; font-family: inherit; font-style: inherit; font-weight: inherit; height: 16px; margin: 0px; padding: 0px; vertical-align: middle; width: 16px;" title="Add ARNA to My Watchlist"> </a>) . Orexigen will directly compete with both companies. So far both Arena and Vivus have had trouble generating meaningful amounts of revenue from their products. Arena and its partner<strong style="border: 0px; font-family: inherit; font-style: inherit; margin: 0px; padding: 0px;"> Eisai Pharmaceuticals</strong> generated a measly $8.4 million. While this represented a substantial increase in revenue, it is nowhere near where Arena will need to be for profitability (in fact Arena lost $25.3 million last quarter). This is nowhere near profitability for Arena. The numbers for Vivus are only slightly better, with Vivus recognizing $9.1 million in <a href="http://finance.yahoo.com/news/vivus-reports-first-quarter-2014-200000570.html" style="border: 0px; color: #339933; font-family: inherit; font-style: inherit; font-weight: inherit; margin: 0px; padding: 0px;">net product revenue</a> . Even though revenue increased, the amount of prescriptions written for Qsymia actually dropped when compared to the fourth quarter of 2013.</div>
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However another competitor entering the marketplace could spell trouble for both Vivus and Arena. Contrave seems to be between Belviq and Qsymia in terms of effectiveness, and should it receive FDA approval it could pose a serious problem for Arena patients who are not seeing enough weight loss or for Qsymia patients who are worried about some of the potential side effects of the drug. According to the FDA, Qsymia in clinical trials was shown to have side effects including complications during pregnancy and increased heart rate. Qsymia is also, notably, not recommended for patients who have heart disease . Should Orexigen be able to avoid label issues like these, Contrave could have a leg-up in the competitive landscape. Orexigen also has a marketing partner in <strong style="border: 0px; font-family: inherit; font-style: inherit; margin: 0px; padding: 0px;">Takeda</strong>, which is a notable improvement over Vivus. Orexigen and its partner are making a huge bet on the drug, as Takeda plans to market Contrave through <a href="http://seekingalpha.com/article/2205283-orexigen-therapeutics-orex-ceo-mike-narachi-on-q1-2014-results-earnings-call-transcript" style="border: 0px; color: #339933; font-family: inherit; font-style: inherit; font-weight: inherit; margin: 0px; padding: 0px;">900 sales representatives</a> upon approval. With this in mind they could potentially capture a large share of the market if the drug is ultimately approved. Given Orexigen's intent to grab business away from Arena and Vivus, let's take a look at the opportunities.</div>
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<strong style="border: 0px; font-family: inherit; font-style: inherit; margin: 0px; padding: 0px;">Clinical data</strong><br />
Orexigen has more extensive safety data around their product, due to the additional trials conducted after receiving a CRL on Contrave. The trials focused on the incidence of heart attack and stroke. In the cardiovascular outcomes study, an interim analysis showed that Contrave did not meaningfully increase the incidence of heart attack and stroke. Notably, both Arena and Vivus have not yet conducted their own cardiovascular outcome studies. The positive safety profile should later help Orexigen as a marketing tool as side-effects are a concern with current therapies and the cardiovascular effects of these weight loss drugs has been a concern for the FDA. While there have not been any notable cardiovascular problems with either Qsymia or Belviq, Orexigen being the only company with cardiovascular outcomes data could have an advantage in the marketplace.</div>
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<strong style="border: 0px; font-family: inherit; font-style: inherit; margin: 0px; padding: 0px;">Efficacy</strong>It is important to note as Orexigen once again goes in front of the FDA that the efficacy of Contrave is largely not in doubt. While the three drugs cannot be easily compared to each other given difference in study design, all three showed effectiveness, in terms of the amount of people who lose 5% or more of their body weight. With this in mind, Contrave will be an effective option in terms of the efficacy/side-effect balance that doctors will have to do. Now, it is important to note that Contrave potentially may have a more worrisome safety profile than Belviq (regarding side effects: Contrave patients reported dizziness and increased blood pressure, while Belviq patients reported dizziness and dry mouth).</div>
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<strong style="border: 0px; font-family: inherit; font-style: inherit; margin: 0px; padding: 0px;">Final thoughts</strong>Orexigen is prepared to make a significant investment in Contrave. Orexigen entering the market should help to shake up the weight loss market, as the company and its drug could gain traction assuming approval. I think the cardiovascular outcomes data could help make a crucial difference here, as will the large sales force that Takeda is prepared to deploy for this drug. Time will tell.</div>
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Disclosure: The author holds a position in Orexigen, and no position in any other stock mentioned. </div>
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amaxhttp://www.blogger.com/profile/08410478051767591573noreply@blogger.com0tag:blogger.com,1999:blog-1352585073800931048.post-74142754161471068222014-08-03T05:36:00.003-07:002014-08-03T05:36:57.877-07:00Is There Any Hope Left For Dendreon<div dir="ltr" style="text-align: left;" trbidi="on"><div style="background-color: white; border: 0px; color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 14px; line-height: 22px; margin-bottom: 11px; margin-top: 11px; padding: 0px;"><strong style="border: 0px; font-family: inherit; font-style: inherit; margin: 0px; padding: 0px;">Dendreon Corporation</strong> (<span class="ticker" style="border: 0px; font-family: inherit; font-style: inherit; font-weight: inherit; margin: 0px; padding: 0px;">NASDAQ: <a class="qsAdd qs-source-isssitthv0000001" data-id="203319" href="http://caps.fool.com/Ticker/DNDN.aspx?source=isssitthv0000001" style="border: 0px; color: #339933; font-family: inherit; font-style: inherit; font-weight: inherit; margin: 0px; padding: 0px;">DNDN</a></span> <a class="addToWatchListIcon qsAdd qs-source-iwlsitbut0000010" href="http://my.fool.com/watchlist/add?ticker=DNDN&source=iwlsitbut0000010" style="background-image: url(http://g.foolcdn.com/common/img/buttons/BtnAdd.gif); background-position: 0px 0px; background-repeat: no-repeat; border: 0px; color: #339933; display: inline-block; font-family: inherit; font-style: inherit; font-weight: inherit; height: 16px; margin: 0px; padding: 0px; vertical-align: middle; width: 16px;" title="Add DNDN to My Watchlist"> </a>) shareholders have been on a rollercoaster over the past few years. Dendreon got their lead product Provenge approved for use in metastatic castration-resistant prostate cancer, but has been unable to profitably produce and market the drug, reporting net losses every year that Provenge was on the market. With this in mind, we need to ask ourselves whether this is the end of the line for Dendreon.</div><div style="background-color: white; border: 0px; color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 14px; line-height: 22px; margin-bottom: 11px; margin-top: 11px; padding: 0px;"><strong style="border: 0px; font-family: inherit; font-style: inherit; margin: 0px; padding: 0px;">Dendreon's debt situation</strong><br />
The biggest indicator of success moving forward will be whether or not Dendreon will be able to meet its rather substantial debt obligations. Dendreon recently announced the payment of its 2014 notes, but these notes are just a tiny fraction of what they will have to pay in 2016.</div><div style="background-color: white; border: 0px; color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 14px; line-height: 22px; margin-bottom: 11px; margin-top: 11px; padding: 0px;">The 2016 notes represent a large catalyst for shareholders, with $620 million due -- significantly more than the $155 million Dendreon has in cash. Dendreon’s cash position continues to worsen, as cash burn was around $30 million last quarter; management estimates a similar burn this coming quarter. And Provenge sales haven’t impressed – last quarter, company revenue was $68.8 million, roughly in line with revenue over the past five quarters.</div><div style="background-color: white; border: 0px; color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 14px; line-height: 22px; margin-bottom: 11px; margin-top: 11px; padding: 0px;">Investors who still hang onto hope regarding Dendreon will point to the opening of the European market. They hope to see significant new sales in Europe, which will begin to ramp up in the fourth quarter of this year. But those sales will require infrastructure, production, and sales force investments that may further strain Dendreon’s resources.</div><div style="background-color: white; border: 0px; color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 14px; line-height: 22px; margin-bottom: 11px; margin-top: 11px; padding: 0px;"><strong style="border: 0px; font-family: inherit; font-style: inherit; margin: 0px; padding: 0px;">What about other options?</strong><strong style="border: 0px; font-family: inherit; font-style: inherit; margin: 0px; padding: 0px;"><br />
</strong>The recent departure of Dendreon’s CEO John Johnson has left investors hoping for a buyout. But I don’t see an unprofitable drug and a large debt pile as attractive to a potential acquirer. Even if another company stepped in to buy Dendreon, I don’t think it would necessarily be for any sort of premium -- after all, the company doesn’t appear to have many options given its financial straits. And given Dendreon’s current market cap of under $400 million, share dilution sufficient to pay off the debt seems like an unattractive alternative for shareholders.</div><div style="background-color: white; border: 0px; color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 14px; line-height: 22px; margin-bottom: 11px; margin-top: 11px; padding: 0px;"><strong style="border: 0px; font-family: inherit; font-style: inherit; margin: 0px; padding: 0px;">Bottom line</strong><strong style="border: 0px; font-family: inherit; font-style: inherit; margin: 0px; padding: 0px;"><br />
</strong>Dendreon will have a hard time meeting its 2016 debt obligations. With continuing losses and no immediate hope to turn them around, I’m not sure that Dendreon will have the cash needed to keep operating. While some investors might see this as a turnaround opportunity, I don’t see the oncoming barriers as surmountable, and I think that biotech investors have better places to park their money.</div><script async src="//pagead2.googlesyndication.com/pagead/js/adsbygoogle.js"></script><br />
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</div>amaxhttp://www.blogger.com/profile/08410478051767591573noreply@blogger.com0tag:blogger.com,1999:blog-1352585073800931048.post-49144315414020137692014-07-30T16:17:00.001-07:002014-08-03T05:38:19.639-07:00Will FDA Labeling Be Mannkind's Downfall<div dir="ltr" style="text-align: left;" trbidi="on"><div style="background-color: white; border: 0px; color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 14px; line-height: 22px; margin-bottom: 11px; margin-top: 11px; padding: 0px;"><strong style="border: 0px; font-family: inherit; font-style: inherit; margin: 0px; padding: 0px;">MannKind Corporation </strong> <span data-id="209110" style="border: 0px; font-family: inherit; font-style: inherit; font-weight: inherit; margin: 0px; padding: 0px;"> ( <span class="ticker" style="border: 0px; font-family: inherit; font-style: inherit; font-weight: inherit; margin: 0px; padding: 0px;">NASDAQ: <a class="qsAdd qs-source-isssitthv0000001" data-id="209110" href="http://caps.fool.com/Ticker/MNKD.aspx?source=isssitthv0000001" style="border: 0px; color: #339933; font-family: inherit; font-style: inherit; font-weight: inherit; margin: 0px; padding: 0px;">MNKD</a> <a class="qsAdd qs-source-isssitthv0000001" data-id="209110" href="http://caps.fool.com/Ticker/MNKD.aspx?source=isssitthv0000001" style="border: 0px; color: #339933; font-family: inherit; font-style: inherit; font-weight: inherit; margin: 0px; padding: 0px;"></a></span> <a class="addToWatchListIcon qsAdd qs-source-iwlsitbut0000010" href="http://my.fool.com/watchlist/add?ticker=MNKD&source=iwlsitbut0000010" style="background-image: url(http://g.foolcdn.com/common/img/buttons/BtnAdd.gif); background-position: 0px 0px; background-repeat: no-repeat; border: 0px; color: #339933; display: inline-block; font-family: inherit; font-style: inherit; font-weight: inherit; height: 16px; margin: 0px; padding: 0px; vertical-align: middle; width: 16px;" title="Add to My Watchlist MNKD"> </a> ) Investors were finally successful, after multiple Attempts horse in obtaining FDA approval for Afrezz. There have been many different articles recently about the potential for partnerships for MannKind. However, I believe that importante These authors are missing the point - the hinderances to a partnership. The FDA <a href="http://www.mannkindcorp.com/Collateral/Documents/English-US/Afrezza_PrescribingInformation.pdf" style="border: 0px; color: #339933; font-family: inherit; font-style: inherit; font-weight: inherit; margin: 0px; padding: 0px;">labeling</a> of Afrezz restricted mayer have a partnership, and may hobble to the launch of Afrezz before it even started.</span></div><div style="background-color: white; border: 0px; color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 14px; line-height: 22px; margin-bottom: 11px; margin-top: 11px; padding: 0px;"><strong style="border: 0px; font-family: inherit; font-style: inherit; margin: 0px; padding: 0px;">Post-approval requirements are troubling</strong> One of the most notable parts about it was that the FDA label Explicitly told doctors to prescribe notes Afrezz tour Hasta with respiratory issues. The FDA went even further, requiring doctors to have to Afrezz spirometry tests before prescribing, and every six months thereafter. Looking forward to long term effects, as a <a href="http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm403122.htm" style="border: 0px; color: #339933; font-family: inherit; font-style: inherit; font-weight: inherit; margin: 0px; padding: 0px;">post approval commitment</a> MannKind is required to educate doctors about this risk and to conduct additional post approval studies Evaluating the long term effect of Afrezz on lung function and cardiovascular risk, as well as safety and efficacy in children. These post approval studies will likely cost millions of dollars, any partner, and years in terms of the time needed to monitor all of the Patients in the trial. And if the data comes back negative cardiovascular and lung function in the study, it could give reason to withdraw the FDA for marketing approval or slap it with a stronger warnings to Afrezz.</div><div style="background-color: white; border: 0px; color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 14px; line-height: 22px; margin-bottom: 11px; margin-top: 11px; padding: 0px;"><strong style="border: 0px; font-family: inherit; font-style: inherit; margin: 0px; padding: 0px;">Other warnings</strong> The FDA was also concerned about the Increased risk of lung cancer. This could be a hidden dagger for MannKind to Afrezz should be shown to the increased risk of lung cancer in the post-approval studies. This would be a substantial risk to any site, as it would mean huge marketing give this down the toilet. Even more Importantly, it is a red flag for doctors. Even though the label notes that "in Patients with a history of lung cancer or at risk for lung cancer, the benefit should outweigh this potential risk of Afrezz user," why take the risk? With a myriad of other treatment options available, I would expect doctors to turn to what they know works. Exubera encountered similar problems with its label, which helped me to Contribute to its downfall.</div><div style="background-color: white; border: 0px; color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 14px; line-height: 22px; margin-bottom: 11px; margin-top: 11px; padding: 0px;">The FDA even MannKind required to include in their labeling a risk of hypoglycemia. All insulin, carry this warning, however, the issue is that for MannKind, without labeling reflecting enhanced control of hypoglycemia, the risk / reward proposition may be further complicated for doctors. And again, there is the overhang of those post-marketing trials.</div><div style="background-color: white; border: 0px; color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 14px; line-height: 22px; margin-bottom: 11px; margin-top: 11px; padding: 0px;"><strong style="border: 0px; font-family: inherit; font-style: inherit; margin: 0px; padding: 0px;">How partnerships are affected</strong> MannKind is planning on bringing in a partner to market to Afrezz. However, the less than favorable label and the fact that it lacks the financial resources MannKind likely to launch the drug itself will likely weaken in partnership Negotiations MannKind's hand. I also wonder if a partner Difficulty getting Insurers will have to go along with some recommending to Afrezz. Regardless, the fact that a partner would likely have to pay millions of dollars to fund trials of thes What Appears to be upfront and also accept a Potentially risky hurt the partnership will launch discussions, MannKind Potentially leaving in a weak position.</div><div style="background-color: white; border: 0px; color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 14px; line-height: 22px; margin-bottom: 11px; margin-top: 11px; padding: 0px;"><strong style="border: 0px; font-family: inherit; font-style: inherit; margin: 0px; padding: 0px;">Bottom line</strong> in The labeling of Afrezz could make it tough to convince doctors to prescribe the product, and will make it hard for a partner MannKind to attracti. Even though the FDA's approval was welcome news for Investors MannKind, I wonder if they'll find the label to be a serious block for uptake and, by extension, in partnership discussions.</div><script async src="//pagead2.googlesyndication.com/pagead/js/adsbygoogle.js"></script><br />
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</div>amaxhttp://www.blogger.com/profile/08410478051767591573noreply@blogger.com0tag:blogger.com,1999:blog-1352585073800931048.post-48199045115117018362014-01-31T09:42:00.004-08:002014-01-31T09:42:56.982-08:00Interesting Ideas for CVR<div dir="ltr" style="text-align: left;" trbidi="on">
I was searching around the other day and found an interesting Contingent Value Rights play. For those of you who are unaware of what that is, when a company is bought out sometimes the acquiring company will issue CVRs to the shareholders (these can be traded like any stock) which entitles the holder to receive a cash payment if certain criteria are met.<br />
<br />In this case, the CVR that I came across and personally really like is GCVRZ. This deals with Sanofi's acquisition of Genzyme and specifically Genzyme's drug Lemtrada. If Lemtrada meets certain sales milestones worldwide and via specific regions then shareholders will be eligible to receive cash payments. I am a big fan of this CVR because although the FDA made the bonehead move of rejecting Lemtrada, I believe in the potential for the drug. Also, with the CVRs trading at 40 cents, it might be a nice time to buy considering that should Lemtrada hit its milestones that the minimum payout would be around $1 per right.<br />
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For more information I recommend looking at a very interesting <a href="http://seekingalpha.com/article/1975891-an-option-on-adoption-of-a-new-multiple-sclerosis-treatment?source=yahoo" target="_blank">article</a> on Lemtrada. </div>
amaxhttp://www.blogger.com/profile/08410478051767591573noreply@blogger.com0tag:blogger.com,1999:blog-1352585073800931048.post-51695798724723043082014-01-31T09:13:00.005-08:002014-01-31T09:14:04.878-08:00VRNG: An impressive run so far.<div dir="ltr" style="text-align: left;" trbidi="on">
Vringo (VRNG) has been the fortunate recipient of some very interesting news over the past few days. First the judge ruled that Google's workaround is not really a workaround and that they still owe Vringo royalties. The second and possibly bigger ruling came when the judge even enhanced the royalty rate to 6.5% of the royalty base of Google's US revenues. This could be an interesting stock to watch and expect a Seeking Alpha article out later on Vringo's recent developments. </div>
amaxhttp://www.blogger.com/profile/08410478051767591573noreply@blogger.com0tag:blogger.com,1999:blog-1352585073800931048.post-80742030502665905982013-07-23T05:59:00.000-07:002013-07-23T05:59:47.330-07:00Worlds Responds to Motion for Summary Judgement<div dir="ltr" style="text-align: left;" trbidi="on">
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Worlds (<a href="http://seekingalpha.com/symbol/wddd.ob" style="border: 0px; color: #579fc4; font-family: inherit; font-style: inherit; margin: 0px; outline: 0px; padding: 0px; text-decoration: none; vertical-align: baseline;" title="Worlds, Inc.">WDDD.OB</a>) investors saw a rather substantial decrease in share price drop over the last few weeks. The main events that occurred were a <a href="http://www.scribd.com/doc/149055228/WDDD-SJ-Motion" rel="nofollow" style="border: 0px; color: #579fc4; font-family: inherit; font-style: inherit; margin: 0px; outline: 0px; padding: 0px; text-decoration: none; vertical-align: baseline;" target="_blank">motion</a> for invalidity filed by Activision (<a href="http://seekingalpha.com/symbol/atvi" style="border: 0px; color: #579fc4; font-family: inherit; font-style: inherit; margin: 0px; outline: 0px; padding: 0px; text-decoration: none; vertical-align: baseline;" title="Activision Blizzard, Inc">ATVI</a>), as well as a press release announcing that a crucial markman hearing has been <a href="http://finance.yahoo.com/news/worlds-inc-markman-hearing-rescheduled-113957928.html" rel="nofollow" style="border: 0px; color: #579fc4; font-family: inherit; font-style: inherit; margin: 0px; outline: 0px; padding: 0px; text-decoration: none; vertical-align: baseline;" target="_blank">postponed</a> through the fault of neither party. Neither of these issues are material in affecting World's chances to prevail in its lawsuit.</div>
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<span style="border: 0px; color: black; font-family: inherit; font-style: inherit; font-weight: 700; margin: 0px; outline: 0px; padding: 0px; vertical-align: baseline;">The Drop in Price</span></div>
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The aforementioned motion helped to cause a substantial drop in share price, as investors began to panic over the possibility that the judge would dismiss the patent suit outright. This motion mentioned the problem that the priority date of the parent patent do not extend to all of the patents in suit due to the fact that the patents in suit did not contain a specific reference to the earlier filed application. This is a problem due to the fact that World's own inventions would have then counted as prior art and subsequently served as a basis to invalidate the rest of the patents. The priority date, November 13, 1995, of the parent patent helps to invalidate these concerns as its priority date is within a year of the inventions being available to the public.</div>
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If it were found by the court that these patents did not have the required specification, it was possible that the court would essentially destroy Worlds case. The court would have been able to declare the patents invalid. However, I do not believe that this will be the case and I believe that the court will deny Activision's motion.</div>
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<span style="border: 0px; color: black; font-family: inherit; font-style: inherit; font-weight: 700; margin: 0px; outline: 0px; padding: 0px; vertical-align: baseline;">The Response</span></div>
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Worlds (WDDD) attorneys come out firing in regards to Activision Blizzard's motion. Obviously, Worlds does not see the issue in nearly the same way and declares that the omission was a scriveners error, and therefore is an error that should be overlooked by and corrected by the court. There are a few very important points raised by Worlds in their response. These points can be broken down as follows: 1. The scriveners' error should be overlooked by the court, and should be corrected by the court. 2. The US Patent and Trademark Office (USPTO) in their public system recognizes the priority date of November 13, 1995. 3. Worlds is seeking a certification of the mistake from the USPTO and is asking the USPTO to correct the error. 4. Activision Blizzard misstates the legal precedent and the legal provisions surrounding the scenario.</div>
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It is important to note that in a motion for summary judgment the burden will lie with Activision to prove through clear and convincing evidence that the patents are invalid. The evidence must be viewed in a light that is most favorable to the plaintiff in this scenario. Therefore, Activision would have to surpass a significant hurdle in order to actually have their motion granted. So now without further ado we will look at each of the afforementioned defenses.</div>
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<span style="border: 0px; color: black; font-family: inherit; font-style: inherit; font-weight: 700; margin: 0px; outline: 0px; padding: 0px; vertical-align: baseline;">1. Scriveners' error</span></div>
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From page 6 of the motion:</div>
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"First, the patents-in-suit are entitled to a November 13, 1995 priority date because Worlds properly claimed entitlement to that effective filng date during prosecution of the '045 and '690 patents, Under 35 U.S.C. $$ 119(e) andl20,and37 C.F.R. $ 1.78, apatentee may claim priority to an earlier-filed application by including priorityinformation in its patent application. See E.I. du Pont de Nemours & Co. v. MacDermidPrinting, 525 F.3d 1353 (Fed. Cir. 2008). By referring to Worlds' 1995 provisionalapplication in data sheets filed during prosecution of the '045 and '690 patents, Worldssatisfied this requirement and is entitled to the November 13,1995 effective filing date."</div>
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Essentially, Worlds did everything right in regards to the data sheet when it was filing for the subsequent patents. Worlds argues that it should not be harmed by a scriveners' error at the USPTO. This argument is rather convincing, and there is a large amount of caselaw to support the position that Worlds did nothing wrong in regards to the patents.</div>
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Another interesting quote from the response was:</div>
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"Under Federal Circuit law, "[a]bsent evidence of culpability or intent to deceiveby delaying formal correction, a patent should not be invalidated based on an obviousadministrative error." Hoffer v, Microsoft Corp.,405 F.3d 1326,1331 (Fed. Cir. 2005).Indeed, "[w]hen a harmless error in apatent is not subject to reasonable debate, it can becorrected by the court . . . ." Id. Here, there can be no dispute that (1) any effors in the'045 and '690 patents were harmless and administrative; (2) setting aside any administrative error, the correct effective priority date of the patents-in-suit is November13, 1995; (3) the PTO has already recognized the correct November 13, 1995 effectivefiling date on its PAIR database and website; and (4) there is no evidence of culpabilityor intent on the part of Worlds to delay formal correction. Accordingly, the Court has nobasis to invalidate any of Worlds' patents.:</div>
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In the motion filed by Activision, they failed to assert any wrongdoing by Worlds that would prove the intent to decive. The fact that Actavision failed to make an allegation that Worlds intended to deceive also points to the fact that it was a harmless administrative error that is causing the holdup. Interestingly, the court has the opportunity to even correct the error and dismiss Activision's motion. I expect for the court to decide to just correct what is very clearly an administrative error. Worlds was correct in the way it filed for the patent, because the USPTO messed up when they issued the patent that is not the fault of Worlds and Worlds should not be liable.</div>
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<span style="border: 0px; color: black; font-family: inherit; font-style: inherit; font-weight: 700; margin: 0px; outline: 0px; padding: 0px; vertical-align: baseline;">2. The USPTO recognizes the effective date of November 13,1995</span></div>
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Activision's argument loses even more steam when we come to the fact that even the USPTO recognizes the effective date of November 13, 1995. The USPTO, according to Worlds, accepts this on both their PAIR database and website. The fact that even the USPTO recognizes Worlds claim will help Worlds in its argument that there was simply an administrative error in regards to the patents in suit.</div>
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<span style="border: 0px; color: black; font-family: inherit; font-style: inherit; font-weight: 700; margin: 0px; outline: 0px; padding: 0px; vertical-align: baseline;">3. Worlds is in the process of seeking an acknowledgment of the mistake</span></div>
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On July 5th of this year, Worlds filed for a Certificate of Correction in regards to the '045 patent and the '690 patent. This would of course constitute a formal acknowledgement by the USPTO that the effective date should be November 13, 1995 as Worlds claims. This would of course render Activision's argument moot before the court as the issue will have been deemed for all intents and purposes to be corrected. Note that this is an extra step for Worlds, they have the judge who has the possibility to rectify the mistake and now the USPTO who could simply issue the Certificate of Correction which would render the argument moot.</div>
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<span style="border: 0px; color: black; font-family: inherit; font-style: inherit; font-weight: 700; margin: 0px; outline: 0px; padding: 0px; vertical-align: baseline;">4. Activision Blizzard misstates the law</span></div>
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Even more compelling in its argument is the fact that Activision Blizzard relied on an old interpretation which has recently been updated. In its argument, Activision Blizzard asserted that the 1996 version of 37 C.F.R. 1.7 applied. This is, as Worlds points out, simply wrong and contrary to the policies in place at the USPTO. Activision Blizzard needed to rely upon the 2000 updated version of the policy. Although the patent had an effective date of November 13, 1995 the USPTO regulations for applications filed before November 29, 2000 the 2000 revision is the one that should be used. In the case of both of the patents in question, the dates that the applications were filed precedes the November 29, 2000 cutoff date and as such Activision Blizzard even used the wrong version of the procedures as a focal point of its memorandum.</div>
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<span style="border: 0px; color: black; font-family: inherit; font-style: inherit; font-weight: 700; margin: 0px; outline: 0px; padding: 0px; vertical-align: baseline;">Conclusion</span></div>
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This motion should help to ease investor concerns that the patents will end up being invalidated. It appears as though Activision's motion will be denied by the judge. Worlds raised many good points that Activision will have to disprove through clear and convincing evidence. In this instance, Worlds has the evidence on its side. As such Worlds should easily win this motion, and investors should see an increase in share price due to the fact that the patents are not even close to being invalidated before the Markman hearing. The next important catalyst to watch for Worlds will be the Markman hearing, in which the court will rule on a few claim construction issues.</div>
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amaxhttp://www.blogger.com/profile/08410478051767591573noreply@blogger.com0tag:blogger.com,1999:blog-1352585073800931048.post-58299218168016066352013-06-28T08:57:00.002-07:002013-07-23T06:00:22.201-07:00Anthera Pharmaceuticals: A Great Long Term Risk/Reward<div dir="ltr" style="text-align: left;" trbidi="on">
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With Anthera Pharmaceuticals (ANTH) trading at near a 52 week low, investors are left wondering whether or not this is the start of a new trend? While Anthera may drop further based on an impending <a _fcksavedurl="http://finance.yahoo.com/news/anthera-pharmaceuticals-announces-receipt-nasdaq-204500860.html" href="http://finance.yahoo.com/news/anthera-pharmaceuticals-announces-receipt-nasdaq-204500860.html" rel="nofollow" style="color: rgb(2, 73, 153) !important;" target="_blank">Nasdaq delisting,</a> however, it appears as though investors are set up for strong upside potential over the long term. In the pharmaceutical sector few things are certain, and things can happen at any time that drastically change a stock price. Investing in the pharmaceutical sector is not for the risk adverse investor. If you are interested in the pharmaceutical sector, Anthera is definitely a company to consider based on its strong risk/reward profile.</div>
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<strong>Pipeline</strong></div>
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Any investor taking an interest in investing in the long term should look at the clinical pipeline of a company. Anthera has a promising pipeline, which should help to drive the long term growth potential of the company.</div>
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<em>(click to enlarge)</em></div>
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<em><a _fcksavedurl="http://static.cdn-seekingalpha.com/uploads/2013/6/25/618119-1372200760793361-Alexander-Maxwell_origin.png" href="http://static.cdn-seekingalpha.com/uploads/2013/6/25/618119-1372200760793361-Alexander-Maxwell_origin.png" rel="lightbox" style="color: rgb(2, 73, 153) !important;"><img _fcksavedurl="http://static.cdn-seekingalpha.com/uploads/2013/6/25/618119-1372200760793361-Alexander-Maxwell.png" alt="The pipeline at Anthera, according to the company" hspace="6" src="http://static.cdn-seekingalpha.com/uploads/2013/6/25/618119-1372200760793361-Alexander-Maxwell.png" style="max-width: 480px;" vspace="6" /></a></em></div>
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As you can see from the graphic above, Anthera has pipeline that is rather advanced. With the orphan designation in IgA Nephropathy and Phase III enrolling in Systemic Lupus Erythematosus it is easy to see why there is a large amount of long term potential at Anthera.</div>
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<strong>Blisibimod</strong></div>
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Blisibimod is the most advanced compound in Anthera's pipeline. It represents much of the long term future for Anthera, and should it be successful in clinical trials it represents a large amount of upside potential for investors. Just like with any drug trial anything can happen, however, it appears as though Blisibimod has set itself up to be very successful in upcoming clinical trials.</div>
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<strong>Systematic Lupus Erythematosus</strong></div>
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Blisibimod is <a _fcksavedurl="http://investor.anthera.com/releasedetail.cfm?ReleaseID=751677" href="http://investor.anthera.com/releasedetail.cfm?ReleaseID=751677" rel="nofollow" style="color: rgb(2, 73, 153) !important;" target="_blank">entering phase III</a> trials in Systematic Lupus Erythematosus. The phase III trial design is very important for Anthera, indeed phase III trial design can sometimes be the difference between an FDA acceptance and an FDA Complete Response Letter (CRL). In the case of Anthera, there will be two Phase III clinical trials conducted. These trials will be named CHABLIS-SC1 and CHABLIS-SC2. Anthera recently announced the initiation of CHABLIS-SC1. According to the <a _fcksavedurl="http://investor.anthera.com/releasedetail.cfm?ReleaseID=751677" href="http://investor.anthera.com/releasedetail.cfm?ReleaseID=751677" rel="nofollow" style="color: rgb(2, 73, 153) !important;" target="_blank">press release</a>:</div>
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"The Phase 3 CHABLIS-SC1 study is a multicenter, placebo-controlled, randomized, double-blind study designed to evaluate the efficacy, safety, tolerability and immunogenicity of blisibimod in patients with clinically active SLE (SELENA-SLEDAI <u>></u> 10) who have not achieved optimal resolution of their disease with corticosteroid use. The study will enroll patients from Latin America, Asia Pacific and Commonwealth of Independent States who will be randomized to receive blisibimod or placebo for 52 weeks after which they will have the option to receive blisibimod therapy in an open-label, long-term, follow-up safety study. The study will enroll approximately 400 patients and the primary endpoint will be a Systemic Lupus Erythematosus Response Index-8 (SRI-8). "</blockquote>
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The relatively low enrollment of four hundred patients should be easily obtainable for Anthera. The trial protocol was developed based on discussions with the FDA, however, it is important to note that there is not a Special Protocol Assessment (SPA) in place in regards to the trials, which makes it possible that the FDA will later object to trial design and the endpoints. While I do believe that scenario to be unlikely, it is a factor that any informed investor would have to take into account before investing. Furthermore, Anthera's phase II study demonstrated that Blisibimod was successful in patients who had previously failed corticosteroid use. This conclusion was based on a subgroup analysis that was conducted by Anthera.</div>
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This leads us perfectly into talking about the subgroup analysis. Usually I am skeptical of any subgroup analysis in order to design a phase III trial, simply because there are many times where what happened in a subgroup in a phase II trial will not be repeated in a much larger phase III trial. In this case, however, it does appear as though the drug is destined to phase III failure because of the subgroup analysis.</div>
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Systematic Lupus Erythematosus already has a drug on the market. The distinction between Anthera's drug (should it ultimately be successful) and the current drug on the market will help to drive long term value towards Anthera. The other drug on the market is Benlysta, currently marketed by GlaxoSmithKline (GSK), and was developed based on a collaboration with Human Genome Sciences (which was later bought out by GSK for $3 billion).Benlysta has not been selling all that well, in 2012 the drug achieved <a _fcksavedurl="http://www.fiercepharma.com/story/glaxosmithkline-aims-pump-benlysta-new-vasculitis-use/2013-04-03" href="http://www.fiercepharma.com/story/glaxosmithkline-aims-pump-benlysta-new-vasculitis-use/2013-04-03" rel="nofollow" style="color: rgb(2, 73, 153) !important;" target="_blank">sales of $106 million</a>, which was a disappointment for investors based upon all of the hype surrounding Benlysta's launch. Benlysta sales have been hampered, primarily due to the pricing of the drug. This is especially prevelant in some European countries including Britain and Germany.</div>
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In order to succeed where Glaxo has so far been unable to succeed, Anthera is going to need to accomplish a few key things. First of all it is going to have to be successful in obtaining a label that helps to distinguish Blisibimod from Benlysta. Anthera is well aware of the need to have a distinguishing label, saying in their most recent <a _fcksavedurl="http://seekingalpha.com/article/1448541-anthera-pharmaceuticals-management-discusses-q1-2013-results-earnings-call-transcript?source=yahoo" href="http://seekingalpha.com/article/1448541-anthera-pharmaceuticals-management-discusses-q1-2013-results-earnings-call-transcript?source=yahoo" rel="nofollow" style="color: rgb(2, 73, 153) !important;" target="_blank">conference call</a> that:</div>
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"In parallel, we have conducted in-depth analysis of our own blisibimod PEARL-SC Phase II results. These combined analyses have proven to be very helpful in teasing out opportunities and guiding our own Phase III CHABLIS-SC1 trial design. Based on this analysis, eventual success of the CHABLIS-SC1 study could lead to an improved product label , better patient identification for initial product trials at launch and better success in penetrating and growing the SLE market."</blockquote>
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Knowing about the need for unique labeling is important for long term oriented investors, as the company will need to stand out to really have a chance. It is also important for investors to note that Anthera has been conducting an analysis of Benlysta's phase III program in order to develop the CHABLIS-SC1 trial. While this would immediately sound encouraging to investors, it should be taken with a grain of salt given the idea that we do not know how much of an influence the Benlysta studies had upon Anthera's own study design.</div>
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Also, it is likely that Anthera will have to attract a large pharmaceutical partner in order to successfully market the drug in SLE. The problem is that it is possible that there would be less interest from large pharmaceutical companies, simply based on what has happened up to this point in regards to Benlysta.This actually sets Anthera up for an interesting position, in which it wants Benlysta to do well and to meet its projected sales expectations. Companies would then observe the market penetration of Benlysta and if Anthera's compound is successful in clinical trials, they might partner with Anthera in order to take a stab at the growing SLE market and to take on Benlysta. If Anthera were going to partner the drug, they would probably do it after the receipt of the Phase III data. This would be a long term oriented catalyst, given that the Phase III study has an estimated primary completion date of <a _fcksavedurl="http://www.clinicaltrials.gov/ct2/show/NCT01395745?term=Anthera&rank=1" href="http://www.clinicaltrials.gov/ct2/show/NCT01395745?term=Anthera&rank=1" rel="nofollow" style="color: rgb(2, 73, 153) !important;" target="_blank">December 2015</a>.</div>
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As CHABLIS-SC2 starts to come on line, according to the company they plan on meeting with the FDA next quarter in order to discuss the path forward. From the conference call, you can see that the CHABLIS-SC2 study is going to differ from the SC1 study.</div>
<blockquote class="quote" style="border-left-color: rgb(239, 240, 240); border-left-style: solid; border-left-width: 10px; font-family: Verdana, sans-serif; font-size: 13px; margin: 20px 0px; padding: 0px 10px;">
Moving on to the status for the second lupus study. We hope to capitalize on the growing body of clinical evidence that blisibimod will provide significant benefit to lupus patients who have high levels of renal involvement, including patients with stable lupus nephritis/glomerulonephritis.</blockquote>
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The CHABLIS-SC2 study could be what helps to separate Blisibimod from Benlysta. This study could provide Blisibimod with a broader label than Benlysta, and as such help to improve the market potential of the product.</div>
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The market potential for Blisibimod is very hard to predict, simply because it would depend upon the clinical results and the labeling for Blisibimod. While sales potential is hard to predict, it is definitely much more than Anthera's current $80.43 million market cap. The SLE market represents a very enticing market for long term oriented investors, should Anthera be successful in phase III testing, and obtaining FDA approval.</div>
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The following table is a rough sketch of the pending long term catalyst in regards to Blisibimod for the treatment of SLE.</div>
<table border="1" cellpadding="1" cellspacing="1" class="designed_table" style="font-family: Verdana, sans-serif;"><caption>Long term catalysts for Blisibimod in SLE</caption><tbody>
<tr><td style="font-size: 13px;">Catalyst</td><td style="font-size: 13px;">Estimated Time Frame</td></tr>
<tr><td style="font-size: 13px;">CHABLIS-SC1 Completion</td><td style="font-size: 13px;">December 2015</td></tr>
<tr><td style="font-size: 13px;">CHABLIS-SC2 Completion</td><td style="font-size: 13px;">1Q 2016 (this is a guess based on how far behind CHABLIS-SC2 is in terms of initiating a clinical trial)</td></tr>
<tr><td style="font-size: 13px;">Partnership</td><td style="font-size: 13px;">Hard to predict, either before the NDA or after FDA acceptance</td></tr>
<tr><td style="font-size: 13px;">NDA Filing</td><td style="font-size: 13px;">3Q 2016 (this is conservative)</td></tr>
<tr><td style="font-size: 13px;">PDUFA</td><td style="font-size: 13px;">3Q 2017 (assuming standard review)</td></tr>
</tbody></table>
<div style="font-family: Verdana, sans-serif; font-size: 13px;">
This table was illustrative in regards to a couple of ideas. First of all, investors are not clear on how far behind CHABLIS-SC2 is, and exactly what the design specifications are. It is possible for SC2 to catch up to SC1 based on patient enrollment amongst other factors.</div>
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I am not, however, saying that these are the only catalysts in regards to Blisibimod and that investors should simply lock up their money until 2015 based on the hope that Blisibimod works. Blisibimod is also being pursued in other indications, which have the potential to be financially lucrative for Anthera, as well as has the potential to create some more catalysts for long term oriented investors.</div>
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<strong>IgA nephropathy (IgAN)</strong></div>
<div style="font-family: Verdana, sans-serif; font-size: 13px;">
Anthera is also pursuing Blisibimod in a potential indication for IgA nephropathy. IgA nephropathy is a chronic immune renal disease that is typically characterized by proteinura and can sometimes progress to end stage renal disease. Blisibimod would have a relatively large market, should it be approved for the indication.</div>
<div style="font-family: Verdana, sans-serif; font-size: 13px;">
Anthera recently announced that it initiated a <a _fcksavedurl="http://finance.yahoo.com/news/anthera-announces-initiation-bright-sc-123000281.html" href="http://finance.yahoo.com/news/anthera-announces-initiation-bright-sc-123000281.html" rel="nofollow" style="color: rgb(2, 73, 153) !important;" target="_blank">phase II trial</a> called BRIGHT-SC for Blisibimod in IgA nephropathy. This clinical trial has the ability to provide near term catalysts for shareholders, as the trial progresses towards its completion. According to the press release (cited above), this trial appears as though it will be shorter:</div>
<blockquote class="quote" style="border-left-color: rgb(239, 240, 240); border-left-style: solid; border-left-width: 10px; font-family: Verdana, sans-serif; font-size: 13px; margin: 20px 0px; padding: 0px 10px;">
"BRIGHT-SC is a multicenter, placebo-controlled, double-blind, Phase 2 clinical study that is expected to enroll at least 48 patients from Asia Pacific geographies. Patients will be randomized into one active treatment arm or one placebo arm. The primary endpoint of the study will be a reduction in proteinuria at 32 weeks. The Company plans to conduct an interim analysis of proteinuria after patients have completed 8 weeks of therapy. Secondary endpoints will include the effects of blisibimod on estimated Glomerular Filtration Rate (eGFR), plasma B cells, and other biomarkers of kidney disease."</blockquote>
<div style="font-family: Verdana, sans-serif; font-size: 13px;">
The interim analysis at 8 weeks should help to provide a closer catalyst for shareholders. Also, it should not take all that long for Anthera to enroll at least 48 patients in the phase II trial. However, if Anthera increases the enrollment before seeing any of the data, it could be positive for shareholders as the more subjects in the Phase II trial would help to give shareholders more confidence in the Phase III development program. This trial was designed after a May meeting with the FDA. Anthera hopes to present interim data early next year.</div>
<div style="font-family: Verdana, sans-serif; font-size: 13px;">
The market opportunity for IgAN could be quite large for Anthera. Anthera estimates that there are 40,000 people in the United States affected by IgAN This number could actually be low because it seems as though IgAN is underdiagnosed due to the fact that it requires a biopsy, which is not normally completed for patients who have mild urinary abnormalities. The clinical development of Blisibimod in IgAN represents a significant catalyst for shareholders, and could help to drive long term shareprice growth. Significantly, according to the conference call Anthera estimates that there could be millions of people affected by IgAN in Asia, where the prevalence of the disease is much higher.</div>
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Another significant idea about the development of Blisibimod in IgAN is the fact that the disease is an orphan disease. What this means is that due to the fact that there are so few patients who have the disease, if the FDA grants orphan drug designation, the recipient will have market exclusivity for a certain time period as well as other benefits. Typically, orphan drugs can be quite profitable, as companies will substantially increase the price of the drug in the orphan indication, because they are the only drug on the market. This further increases the commercial potential of the IgAN indication for Anthera.</div>
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<strong>Risks</strong></div>
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In order to provide readers with a full view of what the risk/reward is for this stock, it becomes necessary to address some of the risks associated with Anthera. If Blisibimod is found to not work in any of the indications above, the company would not be worth very much money at all. The company has taken a risk by having Blisibimod being the only drug in their pipeline, and if this drug is not successful Anthera would have to develop another pipeline essentially from scratch. Another risk associated with Anthera is that it could be harder for them to raise money given the fact that they might be <a _fcksavedurl="http://finance.yahoo.com/news/anthera-pharmaceuticals-announces-receipt-nasdaq-204500860.html" href="http://finance.yahoo.com/news/anthera-pharmaceuticals-announces-receipt-nasdaq-204500860.html" rel="nofollow" style="color: rgb(2, 73, 153) !important;" target="_blank">delisted from the NASDAQ</a> soon.</div>
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<strong>Financial Position</strong></div>
<div style="font-family: Verdana, sans-serif; font-size: 13px;">
It appears as though Anthera has a rather stable financial position. At the end of March 31,2013 Anthera had $54.4 million in cash. The company mentioned that the amount of cash is "sufficient to deliver on a number of milestones over the next 12 to 18 months." I would expect this to be correct, as from operating activities, Anthera had a <a _fcksavedurl="http://finance.yahoo.com/q/cf?s=ANTH" href="http://finance.yahoo.com/q/cf?s=ANTH" rel="nofollow" style="color: rgb(2, 73, 153) !important;" target="_blank">negative cash flow</a> of approximately $10.63 million. This means that Anthera's cash pile should last roughly through the next five quarters assuming that the expenditures roughly stay the same, and assuming no unexpected revenue.</div>
<div style="font-family: Verdana, sans-serif; font-size: 13px;">
While it is concerning for any company to be cash flow negative, in the case of Anthera I am not overly concerned. Many development stage pharmaceutical companies operate at net losses until their first drug gets on the market (unfortunately, some companies never end up being positive). With this in mind, it is not unusual for Anthera to have a negative cash flow and a net negative in terms of operating expenses. With a cash pile of $54.4 million, the company has removed the immediate risk of dilution for shareholders who take a position. By the time that Anthera would have to raise more cash, it should be at much higher prices due to drug development, we should have Phase II results in IgAN in that time and have a pretty good idea about whether or not the phase III enrollment is on track in SLE.</div>
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<strong>Conclusion</strong></div>
<div style="font-family: Verdana, sans-serif; font-size: 13px;">
Anthera is a very interesting long term proposition. While there may still be some short term downside in Anthera's shareprice, with Anthera trading near its 52 week low it appears as though this is a fantastic risk/reward opportunity for investors. Anthera's holdings have also been relatively stable, with <a _fcksavedurl="http://www.nasdaq.com/symbol/anth/institutional-holdings" href="http://www.nasdaq.com/symbol/anth/institutional-holdings" rel="nofollow" style="color: rgb(2, 73, 153) !important;" target="_blank">institutional ownership</a> of 48.93%, it appears as though Anthera will be a good long term investment. As Anthera progresses Blisibimod through the requisite clinical pipeline, there should be an appreciation in share price. Anthera appears to be a small cap stock with asymmetric long term upside potential.</div>
</div>
amaxhttp://www.blogger.com/profile/08410478051767591573noreply@blogger.com2tag:blogger.com,1999:blog-1352585073800931048.post-36836465914551708532013-06-26T14:17:00.003-07:002014-08-03T05:38:41.808-07:00Pharmaceutical Catalyst Update<div dir="ltr" style="text-align: left;" trbidi="on"><br />
<br />
Pharmaceutical Catalysts: What To Expect In The Next Few Months Update <span class="edit_delete_links" style="border: 0px; font-size: 0.6em; font-style: inherit; margin: 0px; outline: 0px; padding: 0px 0px 0px 5px; vertical-align: baseline;">[<a href="http://seekingalpha.com/account/edit_post/1979742" style="border: 0px; color: #024999; font-family: inherit; font-style: inherit; margin: 0px; outline: 0px; padding: 0px; text-decoration: none; vertical-align: baseline;">Edit</a> or <span class="delete_it" style="border: 0px; color: rgb(2, 73, 153) !important; font-family: inherit; font-style: inherit; margin: 0px; outline: 0px; padding: 0px; vertical-align: baseline;">Delete</span>]</span><a class="num_of_comments" href="http://seekingalpha.com/instablog/618119-alexander-maxwell/1979742-biorunups-what-to-expect-in-the-next-few-months-update#comments_header" style="background-image: url(http://static2.cdn-seekingalpha.com/images/commented_on.gif?1372252959); background-position: 0% 50%; background-repeat: no-repeat no-repeat; border: 0px; color: #999999; font-size: 0.65em; font-style: inherit; margin: 0px 0px 0px 5px; outline: 0px; padding: 0px 0px 0px 19px; text-decoration: none; vertical-align: baseline;">0 comments</a><br />
<div class="instablog_main_content_header" style="background-color: white; border-bottom-color: rgb(191, 200, 205); border-bottom-style: dashed; border-width: 0px 0px 1px; color: #2d2d2d; font-family: arial, helvetica, clean, sans-serif; font-size: 14px; margin: 0px; outline: 0px; padding: 0px 0px 5px; vertical-align: baseline;"><div class="instablog_date_and_more" style="border: 0px; clear: both; color: #999999; font-family: inherit; font-size: 0.95em; font-style: inherit; margin: 5px 0px 0px; outline: 0px; padding: 0px; vertical-align: baseline;">Jun 26, 2013 4:13 PM | about stocks: <a href="http://seekingalpha.com/symbol/atrs/instablogs" style="border: 0px; color: #579fc4; font-family: inherit; font-style: inherit; margin: 0px; outline: 0px; padding: 0px; text-decoration: none; vertical-align: baseline;">ATRS</a>, <a href="http://seekingalpha.com/symbol/aveo/instablogs" style="border: 0px; color: #579fc4; font-family: inherit; font-style: inherit; margin: 0px; outline: 0px; padding: 0px; text-decoration: none; vertical-align: baseline;">AVEO</a>, <a href="http://seekingalpha.com/symbol/dcth/instablogs" style="border: 0px; color: #579fc4; font-family: inherit; font-style: inherit; margin: 0px; outline: 0px; padding: 0px; text-decoration: none; vertical-align: baseline;">DCTH</a>, <a href="http://seekingalpha.com/symbol/depo/instablogs" style="border: 0px; color: #579fc4; font-family: inherit; font-style: inherit; margin: 0px; outline: 0px; padding: 0px; text-decoration: none; vertical-align: baseline;">DEPO</a>, <a href="http://seekingalpha.com/symbol/flml/instablogs" style="border: 0px; color: #579fc4; font-family: inherit; font-style: inherit; margin: 0px; outline: 0px; padding: 0px; text-decoration: none; vertical-align: baseline;">FLML</a>, <a href="http://seekingalpha.com/symbol/rptp/instablogs" style="border: 0px; color: #579fc4; font-family: inherit; font-style: inherit; margin: 0px; outline: 0px; padding: 0px; text-decoration: none; vertical-align: baseline;">RPTP</a>,<a href="http://seekingalpha.com/symbol/scmp/instablogs" style="border: 0px; color: #579fc4; font-family: inherit; font-style: inherit; margin: 0px; outline: 0px; padding: 0px; text-decoration: none; vertical-align: baseline;">SCMP</a>, <a href="http://seekingalpha.com/symbol/ttnp.ob/instablogs" style="border: 0px; color: #579fc4; font-family: inherit; font-style: inherit; margin: 0px; outline: 0px; padding: 0px; text-decoration: none; vertical-align: baseline;">TTNP.OB</a>, <a href="http://seekingalpha.com/symbol/dvax/instablogs" style="border: 0px; color: #579fc4; font-family: inherit; font-style: inherit; margin: 0px; outline: 0px; padding: 0px; text-decoration: none; vertical-align: baseline;">DVAX</a></div></div><div class="posts_content" id="article_body" style="background-color: white; border: 0px; clear: both !important; color: #2d2d2d; float: none !important; font-family: verdana, arial, helvetica, clean, sans-serif; font-size: 13px; left: 0px !important; line-height: 20px; margin: 0px; outline: 0px; padding: 6px 13px 0px 0px; position: relative; vertical-align: baseline; width: 483px !important; z-index: 1; zoom: 1;"><div style="border: 0px; font-family: inherit; font-style: inherit; margin-bottom: 7px; margin-top: 7px; outline: 0px; padding: 0px; vertical-align: baseline;">PDUFA dates can be substantial catalysts for any stocks that are focused on drug development. For small companies it can essentially be a make or break scenario, and the culmination of years of shareholder money as well as years of hard work by the companies. In my previous <a href="http://seekingalpha.com/article/1294581-bio-run-ups-what-to-expect-in-the-next-few-months" rel="nofollow" style="border: 0px; color: #579fc4; font-family: inherit; font-style: inherit; margin: 0px; outline: 0px; padding: 0px; text-decoration: none; vertical-align: baseline;" target="_blank">article</a> I mentioned some possible run up candidates going into FDA panel decisions, as well as going into PDUFA dates. I promised an update to investors as to how these picks worked out, which I will provide below. However, there are a few lessons to be learned through looking at the historical pricing information that I would like to share with you:</div><div style="border: 0px; font-family: inherit; font-style: inherit; margin-bottom: 7px; margin-top: 7px; outline: 0px; padding: 0px; vertical-align: baseline;"><span style="border: 0px; color: black; font-family: inherit; font-style: inherit; font-weight: 700; margin: 0px; outline: 0px; padding: 0px; vertical-align: baseline;">1) FDA panel decisions vary widely in terms of runup potential</span></div><div style="border: 0px; font-family: inherit; font-style: inherit; margin-bottom: 7px; margin-top: 7px; outline: 0px; padding: 0px; vertical-align: baseline;">It appears as though the FDA panel decisions that were recommended often varied quite widely in terms of run up potential. While some of the panel decisions resulted in large catalyst events and large runups, others seem to have been a side note for investors, hardly causing for any runup at all. Often panel decisions can be very interesting for investors, and no one really knows which way they will go. FDA panels are when the FDA asks for the consultation of various people in the affected industries, usually the panel will consist of some doctors as well as other professionals. These panels render non-binding votes on a number of issues. While the panel votes are non-binding, the FDA does usually follow their panels. Unfortunately, panels can be very hard to predict, which is why I often advocate getting out before the FDA panel decision. One perfect example of panels being hard to predict was what happened with Dynavax Technologies (<a href="http://seekingalpha.com/symbol/dvax" style="border: 0px; color: #579fc4; font-family: inherit; font-style: inherit; margin: 0px; outline: 0px; padding: 0px; text-decoration: none; vertical-align: baseline;" title="Dynavax Technologies Corporation">DVAX</a>):</div><div style="border: 0px; font-family: inherit; font-style: inherit; margin-bottom: 7px; margin-top: 7px; outline: 0px; padding: 0px; vertical-align: baseline;">In Dynavax's panel, going in many investors thought that the vote was going to be positive (me included). From an efficacy standpoint, Dynavax's Hepatitis C Drug Heplisav was off the charts. However, there were safety concerns that were raised in the panel which were previously unforeseen by investors. Dynavax went on to receive a CRL based on the panel's concern that there was not enough data on safety, and it looks like Dynavax is going to have to conduct another clinical trial, the question for investors in Dynavax is simply how large the trial is going to have to be, and how long the trial is going to take. Dynavax for me, atleast, is a perfect example of why I dislike holding through FDA panel decisions.</div><div style="border: 0px; font-family: inherit; font-style: inherit; margin-bottom: 7px; margin-top: 7px; outline: 0px; padding: 0px; vertical-align: baseline;"><span style="border: 0px; color: black; font-family: inherit; font-style: inherit; font-weight: 700; margin: 0px; outline: 0px; padding: 0px; vertical-align: baseline;">2) After a negative panel vote, it is not very advantageous from a runup standpoint to get back into the stock</span></div><div style="border: 0px; font-family: inherit; font-style: inherit; margin-bottom: 7px; margin-top: 7px; outline: 0px; padding: 0px; vertical-align: baseline;">It would seem to make sense logically that after a negative panel vote (or one that would seem negative to the investment community), that there would be some investors buying in for the PDUFA date in the hopes that the FDA decision will not be the same as the panel decision. While the logic seems valid, there does not seem to be that great of an incentive for the investment community to actually execute this strategy. Buying a day after the panel vote at the closing price would have resulted in minimal gains in DVAX, the same goes for Titan Pharmaceuticals (<a href="http://seekingalpha.com/symbol/ttnp.ob" style="border: 0px; color: #579fc4; font-family: inherit; font-style: inherit; margin: 0px; outline: 0px; padding: 0px; text-decoration: none; vertical-align: baseline;" title="Titan Pharmaceuticals Inc.">TTNP.OB</a>) if you counted the panel vote as negative. Note that for my calculations I assumed buying at the closing price the day after the FDA panel decision was announced, and selling at the closing price four days before the PDUFA date. Now, turning towards the results of my previous article.</div><div style="border: 0px; font-family: inherit; font-style: inherit; margin-bottom: 7px; margin-top: 7px; outline: 0px; padding: 0px; vertical-align: baseline;"><span style="border: 0px; color: black; font-family: inherit; font-style: inherit; font-weight: 700; margin: 0px; outline: 0px; padding: 0px; vertical-align: baseline;">Results</span></div><div style="border: 0px; font-family: inherit; font-style: inherit; margin-bottom: 7px; margin-top: 7px; outline: 0px; padding: 0px; vertical-align: baseline;">For all of these results, I assumed buying on the closing price the day my article was published (March 22nd), and selling four regular days before the PDUFA date or the panel date depending on what I mentioned in the article. If the four day timeframe landed on a weekend, I generally went to the next trading day unless it was a long weekend (three days or more) where I would have sold the day before the long weekend began. When to sell before a PDUFA date is simply a matter of preference as to when you would want to sell going into a PDUFA date, I tend to hold closer to the line than I think I should. Also, please note that I did not include stocks that have not yet had their PDUFA date. For example Antares Pharmaceuticals (<a href="http://seekingalpha.com/symbol/atrs" style="border: 0px; color: #579fc4; font-family: inherit; font-style: inherit; margin: 0px; outline: 0px; padding: 0px; text-decoration: none; vertical-align: baseline;" title="Antares Pharma Inc">ATRS</a>) which I recommended in my previous article, is not included in the results table.</div><div style="border: 0px; font-family: inherit; font-style: inherit; margin-bottom: 7px; margin-top: 7px; outline: 0px; padding: 0px; vertical-align: baseline;">For panel decisions, I went for a slightly different strategy (AVEO, DCTH and DEPO) for the ending price, I went out to seven trading days before the panel. This is due to the fact that the FDA will release briefing documents typically four to five days before the panel decision. I do not like to hold a stock going into the release of the briefing documents simply because if these documents are negative, than the stock will of course take a hit.</div><table border="1" cellpadding="1" cellspacing="1" class="designed_table" style="border-spacing: 0px; font-family: inherit; font-size: 13px; font-style: inherit;"><caption style="display: block; font-family: inherit; font-style: inherit;">Results table from recommendations of previous article.</caption><tbody style="font-family: inherit; font-style: inherit;">
<tr style="font-family: inherit; font-style: inherit;"><td style="font-family: inherit; font-size: 1em; font-style: inherit;">Stock Ticker</td><td style="font-family: inherit; font-size: 1em; font-style: inherit;">Starting Price (per share)</td><td style="font-family: inherit; font-size: 1em; font-style: inherit;">Ending Price (per share)</td><td style="font-family: inherit; font-size: 1em; font-style: inherit;">Gain/Loss (per share)</td></tr>
<tr style="font-family: inherit; font-style: inherit;"><td style="font-family: inherit; font-size: 1em; font-style: inherit;">Sucampo (<a href="http://seekingalpha.com/symbol/scmp" style="border: 0px; color: #579fc4; font-family: inherit; font-style: inherit; margin: 0px; outline: 0px; padding: 0px; text-decoration: none; vertical-align: baseline;" title="Sucampo Pharmaceuticals, Inc.">SCMP</a>)</td><td style="font-family: inherit; font-size: 1em; font-style: inherit;">$5.88</td><td style="font-family: inherit; font-size: 1em; font-style: inherit;">$6.82</td><td style="font-family: inherit; font-size: 1em; font-style: inherit;">+$0.94 (+15.9%)</td></tr>
<tr style="font-family: inherit; font-style: inherit;"><td style="font-family: inherit; font-size: 1em; font-style: inherit;">Titan Pharmaceuticals</td><td style="font-family: inherit; font-size: 1em; font-style: inherit;">$1.67</td><td style="font-family: inherit; font-size: 1em; font-style: inherit;">$1.75</td><td style="font-family: inherit; font-size: 1em; font-style: inherit;">+$0.08 (+4.7%)</td></tr>
<tr style="font-family: inherit; font-style: inherit;"><td style="font-family: inherit; font-size: 1em; font-style: inherit;">Raptor Pharmaceuticals (<a href="http://seekingalpha.com/symbol/rptp" style="border: 0px; color: #579fc4; font-family: inherit; font-style: inherit; margin: 0px; outline: 0px; padding: 0px; text-decoration: none; vertical-align: baseline;" title="Raptor Pharmaceuticals Corp.">RPTP</a>)</td><td style="font-family: inherit; font-size: 1em; font-style: inherit;">$5.68</td><td style="font-family: inherit; font-size: 1em; font-style: inherit;">$6.67</td><td style="font-family: inherit; font-size: 1em; font-style: inherit;">+$0.99 (+17.4%)</td></tr>
<tr style="font-family: inherit; font-style: inherit;"><td style="font-family: inherit; font-size: 1em; font-style: inherit;">Delcath Systems (<a href="http://seekingalpha.com/symbol/dcth" style="border: 0px; color: #579fc4; font-family: inherit; font-style: inherit; margin: 0px; outline: 0px; padding: 0px; text-decoration: none; vertical-align: baseline;" title="Delcath Systems, Inc.">DCTH</a>)</td><td style="font-family: inherit; font-size: 1em; font-style: inherit;">$1.69</td><td style="font-family: inherit; font-size: 1em; font-style: inherit;">$1.51</td><td style="font-family: inherit; font-size: 1em; font-style: inherit;">-$0.18 (-10.7%)</td></tr>
<tr style="font-family: inherit; font-style: inherit;"><td style="font-family: inherit; font-size: 1em; font-style: inherit;">Aveo Pharmaceuticals (<a href="http://seekingalpha.com/symbol/aveo" style="border: 0px; color: #579fc4; font-family: inherit; font-style: inherit; margin: 0px; outline: 0px; padding: 0px; text-decoration: none; vertical-align: baseline;" title="AVEO Pharmaceuticals, Inc.">AVEO</a>)</td><td style="font-family: inherit; font-size: 1em; font-style: inherit;">$7.50</td><td style="font-family: inherit; font-size: 1em; font-style: inherit;">$8.27</td><td style="font-family: inherit; font-size: 1em; font-style: inherit;">+$0.77(+10.27%)</td></tr>
<tr style="font-family: inherit; font-style: inherit;"><td style="font-family: inherit; font-size: 1em; font-style: inherit;">DepoMed Inc. (<a href="http://seekingalpha.com/symbol/depo" style="border: 0px; color: #579fc4; font-family: inherit; font-style: inherit; margin: 0px; outline: 0px; padding: 0px; text-decoration: none; vertical-align: baseline;" title="DepoMed, Inc.">DEPO</a>)</td><td style="font-family: inherit; font-size: 1em; font-style: inherit;">$5.76</td><td style="font-family: inherit; font-size: 1em; font-style: inherit;">$5.71</td><td style="font-family: inherit; font-size: 1em; font-style: inherit;">-$0.05 (-0.09%)</td></tr>
<tr style="font-family: inherit; font-style: inherit;"><td style="font-family: inherit; font-size: 1em; font-style: inherit;">Flamel Technologies (<a href="http://seekingalpha.com/symbol/flml" style="border: 0px; color: #579fc4; font-family: inherit; font-style: inherit; margin: 0px; outline: 0px; padding: 0px; text-decoration: none; vertical-align: baseline;" title="Flamel Technologies S.A.">FLML</a>)</td><td style="font-family: inherit; font-size: 1em; font-style: inherit;">$4.59</td><td style="font-family: inherit; font-size: 1em; font-style: inherit;">$4.73</td><td style="font-family: inherit; font-size: 1em; font-style: inherit;">+$0.14 (+3.05%)</td></tr>
</tbody></table><div style="border: 0px; font-family: inherit; font-style: inherit; margin-bottom: 7px; margin-top: 7px; outline: 0px; padding: 0px; vertical-align: baseline;">Average of +5.79% gain. The Dow Jones Industrial Average from March 22nd, 2013 to the day of this article writing (June 24,2013) gained +1.9%. This means that these picks did beat the Dow by 3.89%.</div><div style="border: 0px; font-family: inherit; font-style: inherit; margin-bottom: 7px; margin-top: 7px; outline: 0px; padding: 0px; vertical-align: baseline;">While a 5.79% gain is great, it was not exactly what I was hoping for when writing the article. I was shooting for an average of around 7%. One risk with the Biorunup idea is the fact that there are other catalysts in between which could affect stock price.</div><div style="border: 0px; font-family: inherit; font-style: inherit; margin-bottom: 7px; margin-top: 7px; outline: 0px; padding: 0px; vertical-align: baseline;"><span style="border: 0px; color: black; font-family: inherit; font-style: inherit; font-weight: 700; margin: 0px; outline: 0px; padding: 0px; vertical-align: baseline;">Conclusion</span></div><div style="border: 0px; font-family: inherit; font-style: inherit; margin-bottom: 7px; margin-top: 7px; outline: 0px; padding: 0px; vertical-align: baseline;">While the results were still good, they were not exactly what I would have hoped for in terms of runup potential. It has been very interesting to wait these months and see exactly what kind of a runup investors experienced in these various companies. Some of these companies received extremely good news from the various committees and the FDA, while some of them received bad news. I try not to hold onto a company through the PDUFA date as anything can happen when the FDA is deciding the fate of a drug. I will create an updated biorunup calendar soon and present some more run up opportunities. These will be much further in advance, so hopefully, they will experience a larger run up. I hope that you have enjoyed this experience as much as I have, and continue to be interested in runup investing.</div><div style="border: 0px; font-family: inherit; font-style: inherit; margin-bottom: 7px; margin-top: 7px; outline: 0px; padding: 0px; vertical-align: baseline;"><span style="border: 0px; color: black; font-family: inherit; font-style: inherit; font-weight: 700; margin: 0px; outline: 0px; padding: 0px; vertical-align: baseline;">Disclosure: </span>I am long <a href="http://seekingalpha.com/symbol/atrs" style="border: 0px; color: #579fc4; font-family: inherit; font-style: inherit; margin: 0px; outline: 0px; padding: 0px; text-decoration: none; vertical-align: baseline;" title="Antares Pharma Inc">ATRS</a>. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.</div><script async src="//pagead2.googlesyndication.com/pagead/js/adsbygoogle.js"></script><br />
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</div></div>amaxhttp://www.blogger.com/profile/08410478051767591573noreply@blogger.com0tag:blogger.com,1999:blog-1352585073800931048.post-26876442169920647012013-06-10T05:56:00.000-07:002013-06-29T05:52:55.850-07:00Savient Pharmaceuticals: Is the End Near?<div dir="ltr" style="text-align: left;" trbidi="on">
Savient Pharmaceuticals (NASDAQ: SVNT) recently reported <a href="http://finance.yahoo.com/news/savient-pharmaceuticals-reports-first-quarter-110000939.html" target="_blank">financial results</a> for the first quarter. These results were rather disappointing to both analysts and shareholders, and do not paint a very bright picture for Savient moving forward.<br />
<br />
The news at Savient was rather disappointing. In terms of revenue, analyst estimates were $5.65 million. Savient reported first quarter revenue of $4.69 million. Even more concerning about this revenue number is the fact that net sales of Krystexxa Quarter over Quarter actually decreased by 6%. Savient is relying upon Krystexxa for its hopes of future profitability, and having negative revenue growth does not bode well for the future prospects of the company. Savient's net loss came in at $24.4 million or $0.34 per share. The only bright side about Savient's net loss is that it was a decrease from the net loss from the same period in 2012. The decrease in net loss is mostly due to cost reductions as a result of a corporate restructuring.<br />
<br />
Some more important numbers include the fact that the cost of goods sold actually rose by 106% to $3.6 million. According to the company: "the increase is primarily due to a $2.1 million charge to reserve Krystexxa finished goods and raw material inventory." The good news for shareholders is that it does not look as though the charge will be permanent going forward, however, for this quarter it made the margins shrink at a time when Savient could desperately use increasing margins. Finally the cash burn rate is a concern at Savient. Savient ended the quarter with $68.8 million in cash and cash equivalents. Now this sounds nice, except for when you compare to the prior quarter. For the prior quarter, Savient had cash and cash equivalents of $96.3 million. This represents a cash burn of $27.5 million. At this rate, Savient will be out of cash before the end of the next three quarters.<br />
<br />
The risk of dilution in that scenario would be quite high. Savient is already burdened by an increase in interest associated with debt, due to additional interest due on its 2019 notes. Savient's interest expense increased by 55% to $7.1 million. As an interesting tidbit, this means that total revenue for the quarter at Savient does not even cover their interest expense, clearly something has to give. Furthermore, with Savient looking at a possible <a href="http://biz.yahoo.com/e/130411/svnt8-k.html" target="_blank">Nasdaq delisting</a>, the diminutive nature needed to raise money would be even higher. It becomes harder to dilute stocks that are trading on the OTC, and it seems as though Savient shareholders would want to see more progress before they start forking over more money for the stock. There also becomes the question of who would want the stock? Savient has done a nice job up to this point of painting a rosy picture but with an alarming cash burn rate and decreasing revenue from its main product, it does not seem like any large institutional investors would want to pick up the stock.<br />
<br />
The prospects at Savient look rather bleak. It appears as though Savient will have trouble conserving its cash burn rate, and that its revenues will not increase fast enough to bring Savient to profitability. With a pending delisting added to the mix, it seems as though Savient would have a hard time raising money in order to continue operating. Savient's future, unfortunately, looks rather negative.<br />
<br />
<br /></div>
amaxhttp://www.blogger.com/profile/08410478051767591573noreply@blogger.com0tag:blogger.com,1999:blog-1352585073800931048.post-22801641990579220142013-06-06T10:50:00.002-07:002013-07-23T06:00:52.088-07:00Neonode: A Potential Patent Play?<div dir="ltr" style="text-align: left;" trbidi="on">
<div style="font-family: Verdana, sans-serif; font-size: 13px;">
Neonode (<a _fcksavedurl="http://seekingalpha.com/symbol/neon" href="http://seekingalpha.com/symbol/neon" style="color: rgb(2, 73, 153) !important;" tt="nopar">NEON</a>) has a very well developed business. They have been on a role recently, providing solutions for many large companies. With Neonode creeping ever closer towards profitability, it seems as though Neonode is well positioned as a company. However, there is the possibility that they would become even more well positioned, through the exploitation of their patent portfolio. Neonode holds some seminal patents, which could provide a very lucrative stream of revenue, should Neonode choose to start focusing on enforcement activities. To be clear, we are not talking about destroying the underlying business at Neonode, but simply choosing to essentially add an IP enforcement wing onto the current business model.</div>
<div style="font-family: Verdana, sans-serif; font-size: 13px;">
A very interesting development has been the fact that Neonode patented slide to <a _fcksavedurl="http://www.dailytech.com/Analysis+Neonode+Patented+SwipetoUnlock+3+Years+Before+Apple/article24046.htm" href="http://www.dailytech.com/Analysis+Neonode+Patented+SwipetoUnlock+3+Years+Before+Apple/article24046.htm" rel="nofollow" style="color: rgb(2, 73, 153) !important;" target="_blank">unlock technology</a>...three years before Apple (APPL). The fact that Neonode also commercially deployed this technology would only serve to strengthen the claims in Neonode's enforcement activities. For those of you who are unfamiliar with the patent litigation arena, let's take a step back. Neonode's patent would have priority over Apple's, as Neonode's is older and therefore the assumption is that Neonode had the idea before Apple. Even more interesting is the idea that a court in the UK in 2011 declared Apple's slide to unlock technology invalid, <a _fcksavedurl="http://www.neowin.net/news/apples-slide-to-unlock-patent-ruled-invalid-in-uk" href="http://www.neowin.net/news/apples-slide-to-unlock-patent-ruled-invalid-in-uk" rel="nofollow" style="color: rgb(2, 73, 153) !important;" target="_blank">citing</a> Neonode's 2004 phone which deployed slide to unlock technology. This would also mean that Apple knew about Neonode's invention, as they are now aware that Neonode deployed a similar device before Apple. As a matter of fact in Apple's recent patent application for slide to unlock technology they <a _fcksavedurl="http://www.google.com/patents?id=4vwAAgAAEBAJ&printsec=frontcover&dq=8095879&hl=en&sa=X&ei=YHdCT56bFerE2wXU8qiVCA&ved=0CDQQ6AEwAA" href="http://www.google.com/patents?id=4vwAAgAAEBAJ&printsec=frontcover&dq=8095879&hl=en&sa=X&ei=YHdCT56bFerE2wXU8qiVCA&ved=0CDQQ6AEwAA" rel="nofollow" style="color: rgb(2, 73, 153) !important;" target="_blank">cited</a> Neonode's patent. This is also important because that would mean that Apple was well aware of the issuance of Neonode's patent.This could open Apple up to the status of willful infringer under the law, which would substantially increase damages should a verdict come in against Apple. In February of 2012, Neonode was issued their <a _fcksavedurl="http://appleinsider.com/articles/12/02/28/swedish_company_claims_rights_to_slide_to_unlock_with_new_ui_patent" href="http://appleinsider.com/articles/12/02/28/swedish_company_claims_rights_to_slide_to_unlock_with_new_ui_patent" rel="nofollow" style="color: rgb(2, 73, 153) !important;" target="_blank">patent</a>. They were issued this patent, having initially filed for the patent in 2002, well in advance of Apple. This would make the patent relatively recent, which is always good in the field of IP litigation. The more recently the patent was issued, the longer until the expiration of the patent. Now, why would anyone care about the expiration date of a patent, well the answer is due to future royalties. Should Neonode sue they would undoubtedly seek future royalties for Apple's continued infringement. This would mean that Apple would either have to change their technology, or continue to pay Neonode a set royalty on sales until the expiration of Neonode's patent.</div>
<div style="font-family: Verdana, sans-serif; font-size: 13px;">
More significantly, Neonode has the pieces lined up for a potential IP litigation front. In their <a _fcksavedurl="http://www.neonode.com/wp-content/uploads/2013/03/NEON-4Q-Full-Year-Report.pdf" href="http://www.neonode.com/wp-content/uploads/2013/03/NEON-4Q-Full-Year-Report.pdf" rel="nofollow" style="color: rgb(2, 73, 153) !important;" target="_blank">conference call</a> they mentioned that "our Patent Counsel, Quinn Emanuel is in the later stages of independently evaluating our patents and helping us developing our IP strategy." This would suggest that Neonode is also seeing the value in the IP litigation front. Also of note is the fact that Quinn Emanuel is representing Neonode, Quinn Emanuel is a <a _fcksavedurl="http://bestlawfirms.usnews.com/firms/quinn-emanuel-urquhart-sullivan-llp/overview/35690/" href="http://bestlawfirms.usnews.com/firms/quinn-emanuel-urquhart-sullivan-llp/overview/35690/" rel="nofollow" style="color: rgb(2, 73, 153) !important;" target="_blank">tier one lawfirm</a> in patent litigation. What is even more compelling is that Quinn Emanuel advertises itself as <a _fcksavedurl="http://www.quinnemanuel.com/" href="http://www.quinnemanuel.com/" rel="nofollow" style="color: rgb(2, 73, 153) !important;" target="_blank">trial lawyers</a>, so why would a bunch of trial lawyers be coming together at Neonode? The logical conclusion is that Neonode is getting its proverbial ducks in a row to sue someone. Who we cannot really be sure, however, they have a large patent portfolio protecting their underlying technology platform. With lawyers like Quinn Emanuel working for Neonode, it is safe to expect that Neonode will soon be attempting to monetize some of their IP portfolio, as they should.</div>
<div style="font-family: Verdana, sans-serif; font-size: 13px;">
What makes Neonode an even more compelling IP investment is the fact that Neonode has a strong underlying business. This is very valued in the world of patent monetization, for examples look at the underlying businesses at Document Security (<a _fcksavedurl="http://seekingalpha.com/symbol/dss" href="http://seekingalpha.com/symbol/dss" style="color: rgb(2, 73, 153) !important;" tt="nopar">DSS</a>) or the creation of one at MGT Capital (MGT.OB). This would help to provide a sort of cushion should Neondoe not be successful in its patent monetization case. It would essentially provide a base valuation, a luxury not present at some other monetization companies such as Vringo (<a _fcksavedurl="http://seekingalpha.com/symbol/vrng" href="http://seekingalpha.com/symbol/vrng" style="color: rgb(2, 73, 153) !important;" tt="nopar">VRNG</a>). Furthermore, Neonode could be very successful as Quinn Emanuel claims to have a win rate of over 90%, odds like this have to be attractive to any investor in the monetization industry. Neonode is clearly very well positioned should it want to monetize its patents, to go along with its underlying business.</div>
<div style="font-family: Verdana, sans-serif; font-size: 13px;">
Neonode already has a very successful underlying business, and would be able to branch off into also licensing its IP portfolio. It is interesting, as the amount of IP related lawsuits seems to be soaring in the United States recently. Neonode could be experimenting with possibly shifting towards filing patent infringement lawsuits.</div>
</div>
amaxhttp://www.blogger.com/profile/08410478051767591573noreply@blogger.com1tag:blogger.com,1999:blog-1352585073800931048.post-20059545179394357452013-06-06T08:56:00.002-07:002013-06-29T05:52:55.849-07:00Titan Pharmaceuticals: Will Braeburn Throw in the Towel<div dir="ltr" style="text-align: left;" trbidi="on">
<div style="font-family: Arial, 'Helvetica Neue', Helvetica, sans-serif; font-size: 16px;">
Titan Pharmaceuticals (NASDAQOTC: TTNP) announced on Wednesday an amendment to its agreement with <a data-mce-href="http://finance.yahoo.com/news/titan-pharmaceuticals-announces-amendment-partnership-200500221.html" href="http://finance.yahoo.com/news/titan-pharmaceuticals-announces-amendment-partnership-200500221.html">Braeburn Pharmaceuticals</a>. This amendment specifies some very important concepts for Titan's shareholders. The amendment changed the termination clause in the agreement:</div>
<blockquote style="font-family: Arial, 'Helvetica Neue', Helvetica, sans-serif; font-size: 16px;">
"The amendment primarily modifies certain of the agreement's termination provisions by providing Braeburn the right to terminate the license in the event significant additional clinical work or a material change to the product label will be required by the U.S. Food and Drug Administration (FDA) as a condition to approval of the New Drug Application (NDA) or if the NDA is not approved by June 30, 2014."<br />
<br /></blockquote>
<div style="font-family: Arial, 'Helvetica Neue', Helvetica, sans-serif; font-size: 16px;">
There are a few important parts of this agreement. The "in the event significant additional clinical work" is important, as Braeburn will be able to opt out if additional work is needed. Unfortunately, the press release does not define 'significant' additional clinical work. However, given Titan's <a data-mce-href="http://www.titanpharm.com/press/2013/13-04-30-Titan-CRL.htm" href="http://www.titanpharm.com/press/2013/13-04-30-Titan-CRL.htm">CRL</a> had the following quote:</div>
<blockquote style="font-family: Arial, 'Helvetica Neue', Helvetica, sans-serif; font-size: 16px;">
"<br />
The CRL states that the FDA cannot approve the application in its present form. The FDA has requested additional data supporting the efficacy of Probuphine, including:<br />
<ul>
<li>The ability of Probuphine to provide opioid blockade of relevant doses of agonists</li>
<li>The effect of higher doses of Probuphine, ideally doses more closely approximating the blood plasma levels associated with sublingual doses of buprenorphine of 12 to 16 mg / day</li>
<li>Human factors testing of the training associated with Probuphine’s insertion and removal</li>
</ul>
The CRL also included recommendations regarding product labeling and the implementation of the Risk Evaluation and Mitigation Strategy (REMS)."</blockquote>
<div style="font-family: Arial, 'Helvetica Neue', Helvetica, sans-serif; font-size: 16px;">
It looks as though the FDA may look for additional clinical trials if it is going to want to know about the 12 to 16mg/ day dosage point. If Titan has to conduct additional clinical trials, expect for Braeburn to find an excuse to get out of its partnership with Titan.</div>
<div style="font-family: Arial, 'Helvetica Neue', Helvetica, sans-serif; font-size: 16px;">
Furthermore, it is not entirely certain that the label will not change as the press release even says that the CRL also included recommendations regarding product labeling. As you notice above, if the product label changes, Braeburn has the right to abandon ship. This possible change could also provide a scenario for Braeburn to leave.</div>
<div style="font-family: Arial, 'Helvetica Neue', Helvetica, sans-serif; font-size: 16px;">
However, the most important part of Braeburn's amendment, and why I personally believe that Braeburn will abandon the partnership is the part about an NDA being approved by June 30, 2014. Given the current timeline for FDA submissions, the likelihood of the FDA even reviewing the NDA by that time is relatively low. It would depend upon Titan getting a favorable classification for the response, as well as Titan not having to conduct any additional clinical trials. It is unlikely that Titan will be able to draw up its response in time for a possible approval by June 30, 2014 and thus Braeburn's hand will be strengthened. However, in this scenario an interesting possibility exists. If the review is not completed by June 30th Braeburn could possibly renegotiate the terms of the partnership with Titan to be much more favorable to Braeburn, otherwise Braeburn could threaten to leave the partnership and stick Titan with a product for which Titan will have to find a marketing partner. This strategy could work out for Titan in the end, or it could end up horribly for Titan. </div>
<br />
<blockquote style="font-family: Arial, 'Helvetica Neue', Helvetica, sans-serif; font-size: 16px;">
</blockquote>
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Only time will tell what Braeburn will end up doing about its relationship with Titan. One thing is clear though; Braeburn is looking for a way out if the relationship does not work done. Braeburn has found its ticket out of the relationship, and the question will simply come down to the FDA, Titan, and Braeburn to see if this partnership will last. This amendment reminds me a great deal of what happened to Alexza Pharmaceuticals <span class="ticker" data-id="208920" style="border-bottom-style: dashed; border-bottom-width: 1px; color: #999999;">(NASDAQ: ALXA)</span> with their previous partnership before finding in my opinion an even better partnership. Overall, this could work out for Titan either way, but for right now it seems to be out of Titan's hands and solely dependent upon what the FDA chooses to require. </div>
</div>
amaxhttp://www.blogger.com/profile/08410478051767591573noreply@blogger.com0tag:blogger.com,1999:blog-1352585073800931048.post-82160074890417510422013-06-06T08:51:00.002-07:002013-07-23T06:01:08.228-07:00Document Security Systems: The Importance of a Settlement with Jive Software and Broadvision<div dir="ltr" style="text-align: left;" trbidi="on">
<span style="font-family: Verdana, sans-serif; font-size: 10pt;">Document
Security Systems (</span><a href="http://seekingalpha.com/symbol/dss"><span style="font-family: "Verdana","sans-serif"; font-size: 10.0pt;">DSS</span></a><span style="font-family: Verdana, sans-serif; font-size: 10pt;">) has
been on a tear of press releases over the past month. For a quick background,
Bascom Research is a wholly owned subsidiary of Lexington Technology group.
Lexington Technology has entered into a definitive merger agreement with
Document. Bascom Research filed a patent infringement lawsuit versus Facebook (</span><a href="http://seekingalpha.com/symbol/fb"><span style="font-family: "Verdana","sans-serif"; font-size: 10.0pt;">FB</span></a><span style="font-family: Verdana, sans-serif; font-size: 10pt;">), LinkedIn (</span><a href="http://seekingalpha.com/symbol/lnkd"><span style="font-family: "Verdana","sans-serif"; font-size: 10.0pt;">LNKD</span></a><span style="font-family: Verdana, sans-serif; font-size: 10pt;">), Jive Software (</span><a href="http://seekingalpha.com/symbol/jive"><span style="font-family: "Verdana","sans-serif"; font-size: 10.0pt;">JIVE</span></a><span style="font-family: Verdana, sans-serif; font-size: 10pt;">), Broadvision (</span><a href="http://seekingalpha.com/symbol/bvsn"><span style="font-family: "Verdana","sans-serif"; font-size: 10.0pt;">BVSN</span></a><span style="font-family: Verdana, sans-serif; font-size: 10pt;">) and Novell. This patent
infringement lawsuit has been the center of a few recent press releases by Document
Security, announcing settlement agreements with Defendants. These settlement
agreements are sure to be good for investors in Document.<o:p></o:p></span><br />
<span style="font-family: Verdana, sans-serif; font-size: 10pt;">Document
Security Systems announced that their soon to be subsidiary, Lexington
Technology Group,<span class="apple-converted-space"> </span></span><a href="http://finance.yahoo.com/news/lexington-technology-group-reaches-settlement-184900419.html" target="_blank"><span style="font-family: "Verdana","sans-serif"; font-size: 10.0pt;">settled
with a</span></a><span class="apple-converted-space"><span style="font-family: Verdana, sans-serif; font-size: 10pt;"> </span></span><span style="font-family: Verdana, sans-serif; font-size: 10pt;">Defendant
in the Bascom Patent case. Unfortunately, the<span class="apple-converted-space"> </span></span><a href="http://www.finance.yahoo.com/" target="_blank"><span style="font-family: "Verdana","sans-serif"; font-size: 10.0pt;">press release</span></a><span class="apple-converted-space"><span style="font-family: Verdana, sans-serif; font-size: 10pt;"> </span></span><span style="font-family: Verdana, sans-serif; font-size: 10pt;">did not state which Defendant the
settlement was with. The settlement granted an effective 4% royalty rate, per
the press release. This settlement is with Broadvision. Although not stated in
the press release, this can easily be found through a court filing available<span class="apple-converted-space"> </span></span><a href="http://docs.justia.com/cases/federal/district-courts/california/candce/3:2012cv06297/261587/80/" target="_blank"><span style="font-family: "Verdana","sans-serif"; font-size: 10.0pt;">here</span></a><span style="font-family: Verdana, sans-serif; font-size: 10pt;">. The
settlement with Broadvision will likely provide only minimal revenue.<o:p></o:p></span><br />
<span style="font-family: Verdana, sans-serif; font-size: 10pt;">As
of March 28th, Broadvision was listed with a market cap of $41.93 million.
While the settlement grants an effective 4% royalty rate, keep in mind that
this royalty rate applies only to a certain product from Broadvision, its<span class="apple-converted-space"> </span><a href="http://news.priorsmart.com/bascom-research-v-broadvision-l6RE/#Complaint" target="_blank">Clearvale products</a>. It is unclear how much of Broadvision's
revenue is derived from its Clearvale products, but the product did not have
any revenue in 2011, and likely did not bring in a large amount of revenue in
2012. This being said, Broadvision does seem to be scaling up its Clearvale
products platform, saying in its most recent<span class="apple-converted-space"> </span></span><a href="http://seekingalpha.com/article/1368541-broadvision-s-management-discusses-q1-2013-results-earnings-call-transcript?page=2" target="_blank"><span style="font-family: "Verdana","sans-serif"; font-size: 10.0pt;">conference
call</span></a><span class="apple-converted-space"><span style="font-family: Verdana, sans-serif; font-size: 10pt;"> </span></span><span style="font-family: Verdana, sans-serif; font-size: 10pt;">discussing
earnings that:<o:p></o:p></span><br />
<span style="font-family: Verdana, sans-serif; font-size: 10pt;">In
this release, we enhance Clearvale's ability to control distribution and
display of view only documents. Extend our integration capabilities with
Microsoft SharePoint, and added many other security features required by our
enterprise customers.<o:p></o:p></span><br />
<span style="font-family: Verdana, sans-serif; font-size: 10pt;">The
enhanced Clearvale capabilities will also be added to our BroadVision 9
solution, announced last quarter to offer a unified and integrated engagement
solutions based on Clearvale's social and mobile capabilities, and [K2
e-business] or relationship management platform, which is BroadVision's
personalization and transaction management solution.<o:p></o:p></span><br />
<span style="font-family: Verdana, sans-serif; font-size: 10pt;">The
fact that Broadvision is enhancing Clearvale can only benefit Lexington
Technology and DSS, as thanks to the effective 4% royalty rate, the more sales
that Broadvision obtains, the more money that DSS/Lexington will ultimately
receive.<o:p></o:p></span><br />
<span style="font-family: Verdana, sans-serif; font-size: 10pt;">Also
from the same conference call is a hint at the sales of the Clearvale product
so far:<o:p></o:p></span><br />
<span style="font-family: Verdana, sans-serif; font-size: 10pt;">At
BroadVision, we invest, create greater choices and options for our valued
customers. In Q1, we did 25 Clearvale partner and paid customer transactions<o:p></o:p></span><br />
<span style="font-family: Verdana, sans-serif; font-size: 10pt;">Accoring
to the conference call, Broadvision believes the bookings may provide
significant upside in the future. With this in mind, and the fact that Broadvision
according to recent quarterly filings does appear to be unprofitable, having
posted a<span class="apple-converted-space"> </span></span><a href="http://finance.yahoo.com/news/broadvision-announces-first-quarter-2013-203000510.html" target="_blank"><span style="font-family: "Verdana","sans-serif"; font-size: 10.0pt;">net
loss</span></a><span class="apple-converted-space"><span style="font-family: Verdana, sans-serif; font-size: 10pt;"> </span></span><span style="font-family: Verdana, sans-serif; font-size: 10pt;">of $2.1
million in the first quarter of this year. The revenue appears to be minimal
out of the Clearvale product suite, and therefore seems to be minimal revenue
to Lexington/ DSS. However, in the world of patent litigation or in any world
money helps, so this revenue to Lexington, no matter how minimal, should help
to offset some of the litigation costs with Novell, Facebook and LinkedIn.<o:p></o:p></span><br />
<span style="font-family: Verdana, sans-serif; font-size: 10pt;">On
top of that, Lexington recently announced a settlement with a</span><a href="http://finance.yahoo.com/news/lexington-technology-group-reaches-settlement-202200176.html" target="_blank"><span style="font-family: "Verdana","sans-serif"; font-size: 10.0pt;">second
Defendant</span></a><span class="apple-converted-space"><span style="font-family: Verdana, sans-serif; font-size: 10pt;"> </span></span><span style="font-family: Verdana, sans-serif; font-size: 10pt;">in the
Bascom Patent case. This settlement provides for Lexington to receive an
effective royalty rate of approximately 5%. This settlement appears to be with
Jive Software, according to a</span><a href="http://docs.justia.com/cases/federal/district-courts/california/candce/3:2012cv06296/261619/82/" target="_blank"><span style="font-family: "Verdana","sans-serif"; font-size: 10.0pt;">recent
court filing</span></a><span style="font-family: Verdana, sans-serif; font-size: 10pt;">. Of the two, it seems as though Document/Lexington did much
better with Jive, getting a higher royalty rate against the larger company. As
of May 28th, Jive had a market cap according to</span><a href="http://finance.yahoo.com/q?s=JIVE&ql=1" target="_blank"><span style="font-family: "Verdana","sans-serif"; font-size: 10.0pt;">Yahoo Finance</span></a><span class="apple-converted-space"><span style="font-family: Verdana, sans-serif; font-size: 10pt;"> </span></span><span style="font-family: Verdana, sans-serif; font-size: 10pt;">of $1.10 Billion. The<span class="apple-converted-space"> </span></span><a href="http://news.priorsmart.com/bascom-research-v-jive-software-l6QW/#Complaint" target="_blank"><span style="font-family: "Verdana","sans-serif"; font-size: 10.0pt;">complaint</span></a><span class="apple-converted-space"><span style="font-family: Verdana, sans-serif; font-size: 10pt;"> </span></span><span style="font-family: Verdana, sans-serif; font-size: 10pt;">seems to specifically allege infringement
based on Jive's API product line. According to its recent press release
announcing<span class="apple-converted-space"> </span></span><a href="http://finance.yahoo.com/news/jive-software-announces-first-quarter-200200177.html" target="_blank"><span style="font-family: "Verdana","sans-serif"; font-size: 10.0pt;">earnings</span></a><span class="apple-converted-space"><span style="font-family: Verdana, sans-serif; font-size: 10pt;"> </span></span><span style="font-family: Verdana, sans-serif; font-size: 10pt;">for the first quarter, Jive had product
revenues of $30.7 million. Unfortunately, Jive does not seem to break down the
numbers in their<span class="apple-converted-space"> </span></span><a href="http://seekingalpha.com/article/1387471-jive-software-management-discusses-q1-2013-results-earnings-call-transcript?page=4" target="_blank"><span style="font-family: "Verdana","sans-serif"; font-size: 10.0pt;">conference
call</span></a><span style="font-family: Verdana, sans-serif; font-size: 10pt;">. However, similarly to the other settlement, any revenue that is
obtained by Lexington/DSS as a result of this lawsuit will help to further
finance their legal actions against the rest of the Defendants. However,
besides revenue why would these early settlements be important?<o:p></o:p></span><br />
<span style="font-family: Verdana, sans-serif; font-size: 10pt;">For
an example of why this could be so important we can easily recall the days when
Vringo (</span><a href="http://seekingalpha.com/symbol/vrng"><span style="font-family: "Verdana","sans-serif"; font-size: 10.0pt;">VRNG</span></a><span style="font-family: Verdana, sans-serif; font-size: 10pt;">)
announced a<span class="apple-converted-space"> </span></span><a href="http://www.benzinga.com/news/12/08/2808262/vringo-shares-jump-on-aol-partial-lawsuit-settlement" target="_blank"><span style="font-family: "Verdana","sans-serif"; font-size: 10.0pt;">partial
settlement</span></a><span class="apple-converted-space"><span style="font-family: Verdana, sans-serif; font-size: 10pt;"> </span></span><span style="font-family: Verdana, sans-serif; font-size: 10pt;">with
AOL(AOL). In the case of Vringo, they ended up winning a jury verdict against
all of the Defendants in the case, including Google (</span><a href="http://seekingalpha.com/symbol/goog"><span style="font-family: "Verdana","sans-serif"; font-size: 10.0pt;">GOOG</span></a><span style="font-family: Verdana, sans-serif; font-size: 10pt;">) and AOL amongst others. The
partial settlement well in advance of the trial provided minimal revenues to
Vringo, but the symbolic nature of a settlement was much more revealing.<o:p></o:p></span><br />
<span style="font-family: Verdana, sans-serif; font-size: 10pt;">Now,
jumping back to the DSS news, this settlement serves a few purposes. First of
all, both of the Defendants are essentially acknowledging that the patents are
valid and enforceable. If the Defendants had any beliefs that the patents were
not valid and enforceable, they would probably have continued litigation and
pushed hard for the judge to dismiss the case. This is a very important caveat
in a patent litigation case, as if a patent is not valid and enforceable often
the judge will not even let the jury hear the case.<o:p></o:p></span><br />
<span style="font-family: Verdana, sans-serif; font-size: 10pt;">This
settlement is also important because it provides a starting base for
determining what the patents would realistically be worth in terms of royalties
during a jury trial. By providing a licensing history of 4-5% of the revenue
for infringement, Document would be setting itself up nicely for arguing for an
even larger royalty in post-trial infringement due to the changed bargaining
positions of the parties involved in the litigation. Obviously, if Bascom
Research wins its case than its hand will be considerably strengthened when
determining ongoing royalties. Providing a licensing history will help the jury
to determine reasonable damages, should they ultimately come to the conclusion
that the other Defendants infringed upon the Bascom Research's Patents.<o:p></o:p></span><br />
<span style="font-family: Verdana, sans-serif; font-size: 10pt;">In
addition to the impressive news of a partial settlement, Lexington and
subsequently DSS have a very important date for their patent infringement
lawsuit coming up. Lexington previously<span class="apple-converted-space"> </span></span><a href="http://www.lex-tg.com/news.html?news_id=71749&year=2013&month=3" target="_blank"><span style="font-family: "Verdana","sans-serif"; font-size: 10.0pt;">announced</span></a><span class="apple-converted-space"><span style="font-family: Verdana, sans-serif; font-size: 10pt;"> </span></span><span style="font-family: Verdana, sans-serif; font-size: 10pt;">a markman hearing date for October 2nd,
2013. For those of you less familiar with what a markman hearing is, it is a
time where both sides have presented their proposed language that a jury will
hear as to what the patent covers. The judge will ultimately rule on which
language will be presented to a jury. Obviously, the Plaintiff would like as
broad of language as possible, as that would mean more chances for a finding of
infringement from a jury. Whereas the Defense would like a very narrow
definition, as it will be easier to argue that no infringement occurred. This
date is very important for patent litigation, and often stocks will run up if
they receive a favorable markman ruling for an example see ParkerVision (</span><a href="http://seekingalpha.com/symbol/prkr"><span style="font-family: "Verdana","sans-serif"; font-size: 10.0pt;">PRKR</span></a><span style="font-family: Verdana, sans-serif; font-size: 10pt;">). This date will help to get a
feeling for DSS about where its case will stand. The language will be very
important for both sides in the sense that it will determine how they tailor
their arguments to the jury. Turning back towards the settlement, the fact that
a Defendant chose to settle even before the markman hearing would suggest that
the infringement was pretty obvious no matter how the patent would be
interpreted by the court. Given the recent settlement, I would say that there
is a good chance for DSS to be successful in terms of their markman hearing.<o:p></o:p></span><br />
<br />
<span style="font-family: Verdana, sans-serif; font-size: 10pt;">The
settlement helps to further entrench DSS shareholders, and can help to reassure
shareholders that the patent litigation will ultimately be successful. While
patent litigation is inherently a risky business, the settlement can be nothing
but good news for DSS shareholders, which should help to encourage some other
Defendants to analyze the validity of Document's claims and whether or not it
would be cheaper to settle. The settlement should help to solidify the
positions of long term shareholders, and helps to provide the idea that
Document will be successful in their patent infringement lawsuit. We can only
hope to see a repeat of the Vringo scenario for DSS shareholders and ultimately
see a jury verdict in favor of DSS.<o:p></o:p></span></div>
amaxhttp://www.blogger.com/profile/08410478051767591573noreply@blogger.com2tag:blogger.com,1999:blog-1352585073800931048.post-48204317726196798242013-04-29T14:12:00.000-07:002013-06-29T05:52:55.854-07:00Generex Biotechnology: Why Investors Should Get Out Now!<div dir="ltr" style="text-align: left;" trbidi="on">
<br />
<div style="font-family: Verdana, sans-serif; font-size: 13px;">
In the biotech industry, just like with anything else. There are some companies who thrive, and others who fall into the wastebin. Generex is one of the latter. Not all of us end up with a winner like Vertex Pharmaceuticals (VRTX) or Jazz Pharmaceuticals (JAZZ). For some stocks, it is simply time to sell out and accept the losses that they have incurred since inception.</div>
<div style="font-family: Verdana, sans-serif; font-size: 13px;">
The first stock is a stock that I used to own when I first got into investing, and I sold it a year after that point in time, Generex Biotechnology (GNBT.OB). Generex has been leaking cash for years. Which is truly a shame because their Antigen Express <a _fcksavedurl="http://www.generex.com/news.php/news/738840" href="http://www.generex.com/news.php/news/738840" style="color: rgb(2, 73, 153) !important;">pipeline</a> seems to have quite a bit of quality. I would invest in Antigen, if I ever got the chance to, but not with Generex's management. Antigen as a matter of fact should be its own company by now, according to a <a _fcksavedurl="http://www.antigenexpress.com/news_release.asp?NewsID=155" href="http://www.antigenexpress.com/news_release.asp?NewsID=155" style="color: rgb(2, 73, 153) !important;">statement</a>made by the company on March 30th, 2011. Generex intended to spin out Antigen Express and issue dividends of Antigen Express shares to current shareholders, that was of course contingent upon shareholders approving a reverse stock split. This split was approved on June 8th, 2011; yet Antigen is still controlled by Generex to this day. Generex for some reason also scrapped the plan for the reverse stock split. Antigen was valued at <a _fcksavedurl="http://www.bizjournals.com/boston/blog/mass-high-tech/2011/12/antigen-breast-cancer-vaccine-shows-promise.html" href="http://www.bizjournals.com/boston/blog/mass-high-tech/2011/12/antigen-breast-cancer-vaccine-shows-promise.html" style="color: rgb(2, 73, 153) !important;">over $300 million</a> <a _fcksavedurl="http://www.antigenexpress.com/news_release.asp?NewsID=151" href="http://www.antigenexpress.com/news_release.asp?NewsID=151" style="color: rgb(2, 73, 153) !important;">according to Generex</a>. If this asset is worth so much money, why would Generex's market cap be sitting at a mere $17.97 million? Well, first of all what is mentioned in the press release is simply a "leading national valuation firm" estimated the value of Antigen Express to be at over $300 million. Well, this does not truly help to solve the value of Antigen Express, as I could tomorrow open a valuation firm, but that would not make me credible in terms of my valuation. They should have mentioned the name of the company that did this valuation. Now, moving away from the unrealized talk of the spinoff of Antigen Express, let's dive into Generex's financials and see why I believe that Generex could be on the verge of collapse. Generex, according to their recently filed <a _fcksavedurl="http://finance.yahoo.com/q/is?s=gnbt" href="http://finance.yahoo.com/q/is?s=gnbt" style="color: rgb(2, 73, 153) !important;">financials</a> lost $5 million last quarter. If you notice, Generex had a negative <a _fcksavedurl="http://finance.yahoo.com/q/cf?s=GNBT" href="http://finance.yahoo.com/q/cf?s=GNBT" style="color: rgb(2, 73, 153) !important;">operating cash flow</a> of $1.045 million. The only reason that they finished cash flow positive for that quarter is the fact that they ended up having $1.45 million in the sale of stock and another $708k in net borrowings. Now, before people say it, I know that many 'development' stage biotech companies are net negative for years while progressing their pipeline (although Oral-lyn is still undergoing Phase III testing, for what is now its fifth year of testing, given that it started North American testing on <a _fcksavedurl="http://www.firstwordpharma.com/node/62836?tsid=17" href="http://www.firstwordpharma.com/node/62836?tsid=17" style="color: rgb(2, 73, 153) !important;">April 7th, 2008</a>). In that time for Oral-lyn, Generex has announced two <a _fcksavedurl="http://www.news-medical.net/news/20110711/Preliminary-results-from-Generex-Oral-lyn-clinical-trial-on-type-1-diabetes.aspx" href="http://www.news-medical.net/news/20110711/Preliminary-results-from-Generex-Oral-lyn-clinical-trial-on-type-1-diabetes.aspx" style="color: rgb(2, 73, 153) !important;">phase III trial results</a>, only to discover that they will need more testing. With a dwindling cash supply, it looks as though Antigen's products might not reach the market before bankruptcy. The unrealized potential of Antigen Express is just some more empty talk from Generex.</div>
</div>
amaxhttp://www.blogger.com/profile/08410478051767591573noreply@blogger.com0tag:blogger.com,1999:blog-1352585073800931048.post-46757985948582944362013-04-05T14:47:00.002-07:002013-06-06T10:51:41.500-07:00Another interesting patent play: Single Touch<div dir="ltr" style="text-align: left;" trbidi="on">
Single Touch interactive (SITO) is a company that you doubtlessly have never heard of before. Similarly, I have never heard of SITO until recently. There are a few things that have caught my eye about this company, the first is the fact that it is suing Hulu, and recently sent Facebook a letter regarding Single Touch's intellectual property. They also have retained a rather good IP litigation firm in Polsinelli Shughar<span style="font-family: inherit;">t, a tier one patent litigation firm. This could be one to watch, and SITO is not your typical patent troll in the respect that it also has revenues and a solid core business, very similar to DSS once the merger is finally completed. I will do some more due </span>diligence<span style="font-family: inherit;"> on the company in the upcoming days and post a much more complete bio of why I like this company. This is definitely one to put on your radar!</span></div>
amaxhttp://www.blogger.com/profile/08410478051767591573noreply@blogger.com1tag:blogger.com,1999:blog-1352585073800931048.post-51434641046664763672013-04-04T08:40:00.005-07:002013-06-06T10:51:41.501-07:00Vringo's Appeal: Why it matters<div dir="ltr" style="text-align: left;" trbidi="on">
The purpose of this post is to rather quickly clear up some misconceptions of investors regarding the appeal filed by Vringo (VRNG). Vringo is appealing the laches and past damages portion of the judge's decision. They are not yet able to even appeal the running royalty rate etc. The easiest way to think about the case at this point would be as almost two seperate cases. One phase would be the laches, and the other the Running Royalty rate. This appeal was brought on by the judge's final rejection of Vringo's motion for a new trial yesterday, as soon as the judge rejected that all of the outstanding motions regarding the laches issue was therefore solved. This opened the door for Vringo's appeal.<br />
<br />
This appeal is great for Vringo, as it has the potential to yield a huge amount of money, with little downside as the worst that could happen is that the appeals court keeps the current damages calculation in place, which would mean $30 million for Vringo. I would however speculate that it was more positioning. If Vringo were in negotiations with Google, they just raised the ante and now have a stronger hand going into the negotiations. If Google does not provide the types of numbers that Vringo wants, Vringo will just simply walk away and say that they will see Google in the court of appeals. </div>
amaxhttp://www.blogger.com/profile/08410478051767591573noreply@blogger.com0tag:blogger.com,1999:blog-1352585073800931048.post-16551603599395093402013-03-23T21:01:00.001-07:002013-06-06T10:52:41.678-07:00Some interersting biotechs<div dir="ltr" style="text-align: left;" trbidi="on">
Some of my favorite Biotech stocks right now:<br />
<br />
1. Antares Pharmaceuticals*, as you can see through http://seekingalpha.com/article/1292491-antares-a-compelling-long-term-investment, I lay out some of the reasons why I personally own this stock as well as some compelling reasons that I believe that other people should own this stock.<br />
<br />
2. Titan Pharmaceuticals*- This company recently received a positive opinion from an FDA advisory panel, and received a massive boost in share-price as a result. I would look for it to "fill the gap" between where it was pre-panel and post-panel, before the PDUFA date. http://seekingalpha.com/article/1296401-why-titan-pharmaceuticals-is-currently-undervalued<br />
<br />
3. Looking for a little bit more long-term: An interesting buy at current price levels is Dynavax Pharmaceuticals (DVAX). The interesting part is that you are banking that they are not going to have to run any more trials, as that would hurt the share-price substantially. However, not having to run more trials would allow for a short-turn around time on a response to the CRL, and look for DVAX's meeting with the FDA to end up being positive. Remember that the FDA was the one who asked them to increase the age group, a main concern of the committee. If DVAX refiles relatively quickly we could see a run-up start all over again and subsequently, see huge gains on the stock.<br />
<br />
4. Another more long-term idea is to invest in Amarin. Now I know what you all are saying, Amarin, we have been down that road before. However, I believe that the commercial potential of Vascepa, is huge. Also the Anchor indication coming up could help to boost the patient population. I would own this stock over the long-term.<br />
<br />
Note: stocks with astricks (*) indicate stocks that I currently own. Note: if you would like for me to go more in-depth in any of my stocks please post a comment and I will do my best to go more in-depth.<br />
<br />
This post is meant for entertainment and informational purposes only. This does not constitute investment advice, or an offer to buy or sell securities. Conduct your own due diligence before investing. I have not been compensated for writing this post by any source except amaxstockideas.blogspot.com. Happy investing.</div>
amaxhttp://www.blogger.com/profile/08410478051767591573noreply@blogger.com0tag:blogger.com,1999:blog-1352585073800931048.post-1466805791168556572013-03-21T20:19:00.001-07:002013-06-06T10:52:41.677-07:00Generex Is anything left for this once interesting biotech?<div dir="ltr" style="text-align: left;" trbidi="on">
Generex Pharmaceuticals (GNBT)- Has for years been promising, and promising, and promising... yet nothing has been delivered. Generex has made promise time and time again to help increase the value of the company, for example promising to divest its Antigen Express subsidiary if shareholders would just agree to a reverse stock split. Well, shareholders agreed, and still nothing. Generex promised to have Oral-lyn Phase III trials designed, and still Oral-lyn appears to be sitting dead on the shelf, a multi-million dollar view-piece Collecting dust, and collecting past memories, that is Oral-lyn. Generex has still not cleared up its situation in India, and has still not designed a Phase III trial for AE-37, the one rather promising drug in Generex's pipeline.<br />
<br />
It is truly sad though, this company had such great potential, its Metformin gum would have revolutionized the marketplace, but that project was mysteriously dropped by the company. The system surrounding Oral-Lyn was supposed to help revolutionize the way that Americans perceive diseases and the way in which we treat diseases. Yet, the technology platform is rotting away seemingly, while Generex is burning cash at an alarming rate. At this rate, one must begin to wonder if it would be best for Generex to just go bankrupt, and thus allow for shareholders to buy Antigen Express, and unlock the true value of the company. This company has a chance, but the shareholders must quickly choose, management or the company?<br />
<br />
Note: the views expressed in the article are solely those of the author. This article is meant solely for informational purposes, and is not meant to be investment advice. The author has received no compensation for writing this article (other than from amaxstockideas.blogspot.com). You invest at your own risk, complete your own due diligence before investing in a particular stock. This article cannot be considered an offer to buy or sell securities. </div>
amaxhttp://www.blogger.com/profile/08410478051767591573noreply@blogger.com0tag:blogger.com,1999:blog-1352585073800931048.post-70125741841951884372013-03-21T19:03:00.001-07:002013-06-28T08:58:42.160-07:00Hot Stocks to Watch<div dir="ltr" style="text-align: left;" trbidi="on">
For all of us out there who like to watch stocks, here are some stocks to watch in the upcoming weeks and months in my opinion.<br />
<br />
1. Titan Pharmaceuticals (TTNP)- With their positive advisory vote today, Titan has the potential to start swinging for the fences. The Price per share might see an increase back to the levels where it was before the FDA released documents.<br />
<br />
2. France Telecom (FTE)- While I liked it better a week ago, I do believe that this stock is still one of the more undervalued stocks on the market. Its Forward P/E is very low, and it pays a hefty dividend. These facts combine to the conclusion that FTE could be in buy range.<br />
<br />
3. Vringo (VRNG)- For those of you who have never heard of this company, I will provide some background. It is a company that is primarily engaged in the enforcement of intellectual property rights. This company owns many different patents and recently won a key case against Google for patent infringement. While the jury came back with a running royalty, and some past damages the issues for Vringo remain what the running royalty will be, and if they can overturn the judge's controversial laches ruling. Vringo has the potential to jump based on the court's announcement any day, and the fact that they already won a trial by jury, where the jury found Vringo's patents to be valid, enforceable, and infringed upon helps to lower the possibilities for downside. It is rather clear that Vringo will get something, the question is just how much they will get in damages.<br />
<br />
4. Finally, another stock which as of late I have grown rather fond of is: Worlds inc (WDDD). This is another patent play, and they are suing activision blizzard over patent infringement related to the Call of Duty and World of Warcraft franchises, respectively. These lawsuits have the potential to become huge, and as we get closer to the marksman date, we should see the stock to continue to run.<br />
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I would keep my eye on these stocks in the coming weeks and months ahead, as I believe that they all have huge potential. As always, this article is meant for solely entertainment purposes, and should not be construed as investment advice. This is not an offer to buy or sell securities. You invest at your own risk. I have received no compensation for writing this article, other than from amaxstockideas.blogspot.com</div>
amaxhttp://www.blogger.com/profile/08410478051767591573noreply@blogger.com1tag:blogger.com,1999:blog-1352585073800931048.post-19512103139640573462011-09-08T16:54:00.000-07:002013-06-06T10:52:41.680-07:00Dendreon Opportunity?<div dir="ltr" style="text-align: left;" trbidi="on">Just today Dendreon Corporation (DNDN) announced "corporate restructuring" and that it would cut approximately 500 jobs. This comes on the back of disappointing sales for its Provenge treatment for Prostate Cancer, and an over 60 percent drop in its stock price on the day of the sales. Dendreon has spent a lot of money to open yet another manufacturing plant, and it seems to have atleast initially way over-anticipated the demand of Provenge. DNDN last quarter announced Provenge sales of just 49.6 million dollars, which is substantially lower than analyst estimates. DNDN also withdrew its previous revenue guidance and said that it expects moderate quarter over quarter growth in sales.<br />
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Previously DNDN had predictions of 350 to 400 million dollars in sales for the fiscal year, however that has now been withdrawn by the company.<br />
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The main problem that is facing DNDN is getting reimbursed by insurance companies.Provenge's price tag is a whopping 93 thousand dollars, and insurance companies seem to have a hard time justifying the cost in the face of how many more months it adds to a patient's life.<br />
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For the fourth quarter DNDN reported a net loss of 114.6 million dollars or 79 cents per share. DNDN is quickly bleeding cash and will need for Provenge sales to increase to have any hope.<br />
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The next question really becomes does DNDN have anything else in its pipeline that might be worth investing in? The answer is yes.... kind of. DNDN has a few different drug candidates listed under its pipeline, one of the more promising treatments appears to be a treatment called Sipuleucel-T, which is in Phase II and III trials in Hormone sensitive prostate cancer, as well as in metastatic Prostate Cancer. However, Cancer drug trials take a very long time to run by their very nature, so I am not sure how far away this drug is from the market, but I would say atleast a few years if it can even garner approval.<br />
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DNDN also has some other compounds which are in various stages of clinical trials but for now they seem to be reliant on Provenge for their future success.<br />
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On DNDN I would say invest on what you can see. I would estimate that the sales numbers although initially slumped, will probably pick up later, so the company could still be successful later. I believe that this company is very reliant on Provenge.<br />
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Its a risky bet but it might be worth picking up a few shares and being prepared for their next earnings and seeing if you can make some quick money on this one. DNDN's other drugs appear to be years out, so for right now Provenge seems to be the drug that is going to make or break this company.<br />
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Disclosure: I do not own a position in DNDN, and do not plan on opening one for the next week at least.<br />
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To view all drugs in their pipeline, here is a link to DNDN's home website:<br />
www.Dendreon.com<br />
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To get a quick rundown of the earnings report:<br />
<a href="http://www.thestreet.com/story/11208772/1/dendreon-earnings-provenge-whiffs-badly.html">http://www.thestreet.com/story/11208772/1/dendreon-earnings-provenge-whiffs-badly.html</a><br />
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Hope you enjoyed the post, please leave a comment!</div>amaxhttp://www.blogger.com/profile/08410478051767591573noreply@blogger.com1tag:blogger.com,1999:blog-1352585073800931048.post-56252740066235992002011-09-07T11:54:00.000-07:002013-06-06T10:52:41.684-07:00Amarin Pharmaceuticals a bust or a must?<div dir="ltr" style="text-align: left;" trbidi="on">Recently Amarin Pharmaceuticals has attracted a huge amount of attention about its triglyceride lowering drug AMR-101. The results for the studies speak for themselves, huge improvements over the standard of care and a seemingly best in class status. AMRN also has the potential to not just market the product to people with high triglycerides, but also in the medium level as well, which could be a potential gold mine, remember Loveza was never able to attain the ability to market to the medium level, which would open up a significantly bigger market for the drug. AMRN also says that they might investigate the drug for other cardiovascular indications, however right now it is important to focus on the upcoming events for the company.<br />
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After the Anchor results, the stock shot up to a high of $19.87. It is now around 11 dollars. The real question is is it time to buy, or do you hold off on this one until later? Well this is a complex situation.<br />
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The drug works remarkably well, however there are some serious concerns about the drug's patent protection. The real issue is: Is the drug able to attain sufficient patent protection that would withstand the challenge of a generic drug maker. Recently, the company was denied a patent, which seems to be a big fork in the road. Fortunately, the company does have the ability to appeal the denial and I believe will ultimately succeed in its attempt to patent this product. The company does have major concerns however and this seems to be a steep concern for investors, as very little or no patent protection can mean that getting the drug approved will help generic drug makers a lot more than shareholders.<br />
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Amarin is expected to file an NDA in September for approval in patients with high triglycerides, this would rely on the results from the Marine study. Last I heard, the company was going to include the Anchor results in order to try to get a possible label expansion from the FDA. However, I have also heard that there are going to have to be much more costly and larger trials run in order for the company to obtain approval in medium triglycerides.<br />
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Based on the results so far, the question for the company appears to be when and if this trial is going to be run. The company is still bleeding cash on its balance sheet, although it seems to be sitting on a mountain of cash.<br />
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My conclusion: Amarin on Marine alone should become profitable, and the profits will allow for it to be able to run trials in medium triglycerides, however that is looking pretty far down the road. Maybe, Amarin starts running the trials now...<br />
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Amarin definitely has a best in class drug, and some doctors seeing the results of the Anchor study should probably allow patients to use AMR-101 off label for the treatment of medium triglycerides.<br />
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I believe that the company will ultimately prevail in its patent issues, and that this is a great medium to long term buy for any investor. This drug has the chance to change the life of patients, I also believe that the patent issue seems to be the only thing that is holding a competitor from swooping in and buying out Amarin, so I would expect that if this patent issue is resolved relatively quickly, that we might see some potential suitors come knocking at the door.<br />
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The results of the trial speak for themselves:<br />
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Link to the Anchor results, this one is the one in Medium Triglycerides: <a href="http://www.nasdaq.com/aspx/company-news-story.aspx?storyid=201104180208rttraderusequity_0060&title=amarin-announces-positive-top-line-results-from-anchor-trial-for-amr101">http://www.nasdaq.com/aspx/company-news-story.aspx?storyid=201104180208rttraderusequity_0060&title=amarin-announces-positive-top-line-results-from-anchor-trial-for-amr101</a><br />
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Link to the Marine results, this one is the one in High Triglycerides, serving as the basis for the upcoming NDA: <a href="http://investor.amarincorp.com/releasedetail.cfm?ReleaseID=533361">http://investor.amarincorp.com/releasedetail.cfm?ReleaseID=533361</a><br />
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Amarin could be entering a huge market with a great drug, and a group of executives with experience in the area, this is definitely one to keep on your radar, and possibly a medium to long term buy. </div>amaxhttp://www.blogger.com/profile/08410478051767591573noreply@blogger.com0tag:blogger.com,1999:blog-1352585073800931048.post-80682634527826619902011-09-06T15:56:00.000-07:002013-06-06T10:52:41.685-07:00Biosante Pharmaceuticals Analysis<div dir="ltr" style="text-align: left;" trbidi="on">BPAX is one of my top recommendations. Biosante is a pharmaceutical company whose principal product is a gel, which is being tested to improve the sexual desire of women who have HSDD. This gel is currently in Phase III studies, with the efficacy end of study results due out before year end. The safety study seems to be going well as the data monitoring committee has allowed for the study to continue. I believe that results from the safety study are expected sometime in the early half of 2012 with an NDA being filed shortly after and the product ultimately hitting the market in 2013. This drug could be huge for the company, Pfizer and other pharmaceutical giants have tried to get to this market.... and failed.<br />
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Along with libigel the company has many other near term revenue generating prospects. The main one being that the Bio-T Gel which is being licensed from BPAX to Teva has an upcoming PDUFA date of November 14th. Why is this important? This is important for two reasons, as pursuant to the agreement I believe that BPAX will receive a milestone if the gel is indeed approved, and could receive royalties on any revenues from the product. With a pharmaceutical company like Teva marketing the gel, BPAX could get some nice and solid near term revenues.<br />
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Another noteworthy point is the fact that Biosante has already had one product approved, so they should theoretically know the process that they will have to face in order to get this product approved by the FDA. The product that has already been cleared by the FDA is Elestrin, which was licensed by the company to Azur pharmaceuticals. The company amended the agreement and recieved I believe around 3.16 million dollars for the product. They could recieve over 140 million dollars more if different sales milestones are met, however according to the CEO of Biosante this is unfortunately unlikely.<br />
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Another product in the Biosante Pharmaceuticals pipeline is the pill-plus, which is currently licensed to Pantahari Biosciences. The pill plus is in various Phase II/III tests around the world. This is significant because again if the product is approved it could allow for Biosante Pharmaceuticals to have a solid revenue stream. The Pill-Plus has already passed a Phase II clinical trial.<br />
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One of the more promising drugs in the Biosante pipeline is the melanoma drug, which Biosante Pharmaceuticals licensed to the Hussman foundation. This deal is great for Biosante, because despite the small upfront payment, Biosante has significantly derisked the program. Biosante is eligible for up to 39 million dollars in milestones, and would recieve royalties on any commercial sales of the product.<br />
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Finally, the last product which I am going to focus on is the Pancreatic Cancer vaccine which is currently licensed to Aduro Biotechnology. This vaccine is headed for Phase II trials in the end of 2011 and in my opinion has so far been rather promising.<br />
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In conclusion, I believe that Biosante Pharmaceuticals is a fantastic investment opportunity and should not be overlooked, I myself own BPAX stock and am looking forward to the future of the company. This is a company that has a very robust and promising pipeline, and the money to get through the Libigel Phase III and to the NDA according to the CEO, which helps to significantly reduce the risk of further dilution of the shares. BPAX should experience a run up into the Elestrin PDUFA date, and should also experience a pop on the news of the Libigel Phase III trials. These trials should be positive, given how positive the other Phase II trial for Libigel was, which surpassed any expectations that I had for this company. In conclusion, BPAX is a great company with a robust pipeline, and a most own for any biotech investor!</div>amaxhttp://www.blogger.com/profile/08410478051767591573noreply@blogger.com2tag:blogger.com,1999:blog-1352585073800931048.post-32071580512778748972011-09-06T12:50:00.000-07:002011-09-06T12:50:25.921-07:00What we are all aboutHere at stock ideas for average investors, we are just about that, discussing ideas for stocks. Some of my personal favorites, as the creator of the website, I will from time to time write about. I really appreciate any feedback in the form of comments that you might have. I follow many different stocks, however, I like to focus more on the Biotechnology Sector. Posts about other stock ideas that you would like for me to write about are more than welcome. Thank you for your visit and please enjoy the blog!amaxhttp://www.blogger.com/profile/08410478051767591573noreply@blogger.com0