Sequester or no sequester, the folks at the Food and Drug Administration look to be quite busy in 2013. Their schedules are full with plenty of important decisions that could greatly impact the fates of biotech and pharma companies — and the fortunes of shareholders as well. Here are three FDA decisions that you should watch over the coming months.
1. Will Vascepa be allowed to play limbo?
Much ado has been made about when the FDA will decide on New Chemical Entity, or NCE, status for Amarin Corporation plc (ADR) (NASDAQ:AMRN)‘s cholesterol drug Vascepa and what that decision will be. However, a much more significant FDA decision this year for Amarin will be related to the supplemental New Drug Application, or sNDA, submitted by the company in late February for use of Vascepa in patients with less severe levels of triglycerides.
Vascepa, a highly refined fish oil pill, is currently approved for patients with severe hypertriglyceridemia, which involves triglyceride levels greater than or equal to 500 mg/dL. If the recently submitted sNDA is ultimately approved, patients with greater than or equal to 200 mg/dL triglyceride levels will be able to take Vascepa. This submission is extremely important for Amarin Corporation plc (ADR) (NASDAQ:AMRN), because the number of patients in this group is around 10 times the size of those with severely high triglyceride levels.
Amarin Corporation plc (ADR) (NASDAQ:AMRN) should hear from the FDA within the next couple of months about whether the sNDA has been accepted for review. If it is accepted, the final decision on approval for the new indication would be given in late 2013. If Vascepa is allowed to play limbo by lowering the bar for triglyceride levels, Amarin Corporation plc (ADR) (NASDAQ:AMRN)’s shares should skyrocket.
Antares Pharma Inc (NASDAQ:ATRS) anxiously awaits an FDA decision in October for Otrexup, a self-injection for the treatment of rheumatoid arthritis. The FDA announced on Feb. 27 that Antares Pharma Inc (NASDAQ:ATRS)’ NDA had been accepted for review.
Otrexup uses Antares’ Medi-Jet parenteral drug delivery system to allow patients to self-administer methotrexate, or MTX. An estimated 70% of the 1.3 million Americans with rheumatoid arthritis take MTX alone or with another therapy. MTX is available in tablet form or via injection, but better absorption of the drug is obtained through injection. Antares Pharma Inc (NASDAQ:ATRS) hopes to capture a nice chunk of the market for those patients who currently self-administer with conventional needles or pen injectors.
Should the FDA approve Otrexup, the prospects for Antares Pharma Inc (NASDAQ:ATRS) seem to be quite good. I suspect that many patients will like the idea of taking MTX with the easier self-injection approach offered by the Medi-Jet technology.