3 FDA Decisions You Need to Watch in 2013

Watch stocks you care about

The single, easiest way to keep track of all the stocks that matter...

Your own personalized stock watchlist!

It's a 100% FREE Motley Fool service...

Click Here Now

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.

Small biotech companies usually crash and burn when it comes to launching drugs -- but can Amarin prove the doubters wrong with its new lipid-lowering drug? In our new premium research report, The Motley Fool’s top biotech analyst offers an in-depth look at this drugmaker’s upcoming opportunities, along with reasons to buy and sell this stock today. To find out more simply click here now to claim your copy.

Read/Post Comments (0) | Recommend This Article (1)

Comments from our Foolish Readers

Help us keep this a respectfully Foolish area! This is a place for our readers to discuss, debate, and learn more about the Foolish investing topic you read about above. Help us keep it clean and safe. If you believe a comment is abusive or otherwise violates our Fool's Rules, please report it via the Report this Comment Report this Comment icon found on every comment.

Be the first one to comment on this article.

Compare Brokers

Fool Disclosure

Sponsored Links

Leaked: Apple's Next Smart Device
(Warning, it may shock you)
The secret is out... experts are predicting 458 million of these types of devices will be sold per year. 1 hyper-growth company stands to rake in maximum profit - and it's NOT Apple. Show me Apple's new smart gizmo!

DocumentId: 2327444, ~/Articles/ArticleHandler.aspx, 9/30/2016 12:58:57 AM

Report This Comment

Use this area to report a comment that you believe is in violation of the community guidelines. Our team will review the entry and take any appropriate action.

Sending report...

Today's Market

updated 3 hours ago Sponsored by:
DOW 18,143.45 -195.79 -1.07%
S&P 500 2,151.13 -20.24 -0.93%
NASD 5,269.15 -49.39 -0.93%

Create My Watchlist

Go to My Watchlist

You don't seem to be following any stocks yet!

Better investing starts with a watchlist. Now you can create a personalized watchlist and get immediate access to the personalized information you need to make successful investing decisions.

Data delayed up to 5 minutes

Related Tickers

9/29/2016 4:00 PM
AMRN $3.13 Down -0.11 -3.40%
Amarin CAPS Rating: ****
ATRS $1.77 Up +0.02 +1.14%
Antares Pharma CAPS Rating: ***
AVEO $0.89 Up +0.01 +1.13%
AVEO Pharmaceutica… CAPS Rating: **
ONXX.DL $0.00 Down +0.00 +0.00%
Onyx Pharmaceutica… CAPS Rating: **