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Thursday, September 8, 2011

Dendreon Opportunity?

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.

Previously DNDN had predictions of 350 to 400 million dollars in sales for the fiscal year, however that has now been withdrawn by the company.

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.

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.

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.

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.

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.

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.

Disclosure: I do not own a position in DNDN, and do not plan on opening one for the next week at least.

To view all drugs in their pipeline, here is a link to DNDN's home website:

To get a quick rundown of the earnings report:

Hope you enjoyed the post, please leave a comment!

Wednesday, September 7, 2011

Amarin Pharmaceuticals a bust or a must?

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.

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.

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.

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.

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.

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...

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.

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.

The results of the trial speak for themselves:

Link to the Anchor results, this one is the one in Medium Triglycerides: http://www.nasdaq.com/aspx/company-news-story.aspx?storyid=201104180208rttraderusequity_0060&title=amarin-announces-positive-top-line-results-from-anchor-trial-for-amr101

Link to the Marine results, this one is the one in High Triglycerides, serving as the basis for the upcoming NDA: http://investor.amarincorp.com/releasedetail.cfm?ReleaseID=533361

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. 

Tuesday, September 6, 2011

Biosante Pharmaceuticals Analysis

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.

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.

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.

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.

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.

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.

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!

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Here 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!