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.
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.
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