3 FDA Decisions You Need to Watch in 2013

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's (NASDAQ: AMRN  ) 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, because the number of patients in this group is around 10 times the size of those with severely high triglyceride levels. 

Amarin 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's shares should skyrocket.

2. Waiting on pins and needles
Antares Pharma (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' 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 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 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. 

3. A Tivo for kidney cancer?
By the end of July, we'll know if a "Tivo" for kidney cancer will become available. I'm referring to Tivopath, AVEO Pharmaceuticals' (NASDAQ: AVEO  ) proposed brand name for its drug tivozanib. The FDA accepted the NDA for tivozanib in November and set a final decision date of July 28 of this year.

Tivozanib targets treatment of an advanced form of kidney cancer that occurs in more than 250,000 new patients each year across the world. More than 100,000 people die from the disease each year. Unfortunately, the currently available therapies for advanced kidney cancer can be highly toxic and in many cases only provide less than a year of progression-free survival.

A late-stage clinical trial of tivozanib found that the drug produced fewer adverse effects and increased the median progression-free survival rate compared to Nexavar, which is co-marketed by Bayer and Onyx Pharmaceuticals (UNKNOWN: ONXX.DL  ) .However, the overall survival rate for patients taking tivozanib was slightly lower than Nexavar. Despite this disappointment, good news from the FDA could still be on the way. If tivozanib is ultimately approved, expect AVEO to generate solid sales.

Going fishing
Trying to predict what decisions the FDA will make can be tricky. My guess, though, is that all three companies will receive positive news. I recommend paying especially close attention to Amarin's sNDA. The company already launched Vascepa -- but without a partner. I would be surprised if there aren't several larger organizations carefully following the sNDA process for the drug's second indication. The right decision by the FDA could mean that a big player goes fishing for a fish oil drug.

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