Amarin share prices settle ahead of FDA approval decision Print E-mail
By Brian Wilson   
Tuesday, 15 November 2011 08:26
FDA CalendarShares of Amarin Corporation (AMRN) have been on a slow, but steady decline since April, following some initial excitement about the Irish biotech company's development of AMR101 for the treatment of  high (hyper-) blood levels of triglycerides, the most abundant fatty molecule in most organisms.

As many biotech investors already know, Amarin specializes in the research and development of cardiovascular disorder drugs. More specifically, Amarin focuses on lipid-based treatments. Their flagship product, currently named AMR101, has passed through all its clinical trials and is on the verge of being approved by the FDA. An NDA for AMR101 was submitted in September, 2011 for the treatment of the treatment of very high triglyceride levels. The FDA is expected to respond by November 26, 2011, which will set the decision date for the drug.

As of September 30th 2011, the company was reported to have raised $126 million, which is more than enough to keep the company operational as further clinical trials are initiated for AMR101 for treatment of more specific conditions. This would include the development of AMR 101 for the treatment of patients with mixed dyslipidemia, which is still finishing phase 3 trials.

Amarin doesn’t have any other drugs in its pipeline for the time being, so news on AMR101 should be a major driver for the stock.

The time leading up to the FDA decision could be positive for the stock, as the company continues to promote itself and its main drug at investor conferences and meetings. Considering that the company is only raising cash through outside investment, it’s integral that AMR101 makes it to the market within a reasonable timeframe although the aforementioned cash balance of $126 million won’t likely be exhausted for years.

The BioMedReports FDA Calendar  does show one additional milestone for the company which was tracked from a news release issued in August. In it, the firm stated that it had reached agreement with the FDA on a Special Protocol Assessment agreement for the design of the previously described cardiovascular outcomes study of AMR101 formally titled REDUCE-IT (Reduction of Cardiovascular Events with EPA - Intervention Trial). Amarin previously announced that it achieved the primary endpoints of two Phase III studies of AMR101, both of which were conducted under separate SPAs. Consistent with prior comments, Amarin estimates that the study will require approximately 8,000 patients and take approximately 6 years for completion.The Company anticipates that if, as intended, AMR101 commences REDUCE-IT Outcomes study activities in 2011 that it will be positioned to achieve approximately 50% enrollment before the end of 2012.

Shares appear to have bottomed out at the current support levels but could see some additional volatility just ahead of the key pending FDA decision.






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