This Day On The Street
Continue to site right-arrow
ADVERTISEMENT
This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here
TheStreet Open House

Amarin in Deep Hole so Top Execs Get Cash Bonus Offer

Amarin  (AMRN - Get Report) top executives will earn cash bonuses if the company is able to convince FDA or a judge to allow some expansion of the label covering its prescription-grade fish pill Vascepa.

The new Amarin executive bonus plan was disclosed in a regulatory filing Monday night and echoes what the company told investors on the last quarterly conference call: If FDA cannot be convinced to approve Vascepa for the treatment of mixed dyslipidemia patients (the so-called "Anchor" patient population), Amarin intends to push for inclusion of the "Anchor" data in the Vascepa label without an expanded label indication. 

If Plan A and B fail, Amarin will sue FDA on first amendment grounds, seeking a judge's ruling which would allow the company to speak with doctors about the "Anchor" trial data. 

Amarin President John Thero, R&D chief Steven Ketchum and General Counsel Joe Kennedy are eligible for the one-time cash bonuses of $1500,000 to $250,000 if the company is successful on or before June 30, 2014. Amarin CEO Joe Zakrzewski is not included in the bonus program, according to the company. 

The FDA is expected to decide on the Vascepa label expansion by Dec. 20, but Amarin executives have warned investors not to expect good news based on the agency's stated opposition and the negative votes of an advisory panel in October

The most likely outcome, absent Amarin's successful intervention, will be an FDA decision to reject Vascepa's for mixed dyslipidemia and ask the company to resubmit with additional clinical data demonstrating a positive cardiovascular benefit for patients. Amarin is conducting a large phase III study known as Reduce-It which might provide these data but results are still 3-4 years away. 

Amarin shares have lost 77% of their value this year, hurt by disappointing Vascepa sales, the lack of a marketing partner and the setbacks with the FDA over expanded the drug's label to treat a much larger swath of patients. 

Ever since the negative FDA advisory panel in October, Amarin executives have issued public comments that walk a fine line between expressing a desire to work cooperatively with the FDA and blasting the agency for changing the rule unfairly.

Amarin's rhetoric against the FDA ratcheted higher after the agency last month revoked the Special Protocol Assessment (SPA) agreement covering Vascepa and the "Anchor" mixed dyslipidemia indication. More than anything, this action signaled the FDA's resolve not to veer from its opposition to an expanded Vascepa label. 

Convincing FDA to allow the results from the "Anchor" phase III study to be included in the Vascepa label might be Amarin's best and only shot at partial redemption. The company is likely to argue that a precedent has already been set: FDA granted GlaxoSmithKline's  (GSK - Get Report) request years ago to allow data from a mixed dyslipidemia study to be included in the Lovaza label even though the fish-oil pill is not approved for the treatment of mixed dyslipidemia. 

Despite the Lovaza precedent, FDA may still balk at Amarin's demands because of concerns that including Anchor data in the Vascepa label will allow the company to skirt rules prohibiting off-label marketing. The FDA has also clearly become more conservative and skeptical about the efficacy of prescription fish-oil pills in the absence of additional clinical data. This was not an issue for FDA when Glaxo was seeking to include more data in the Lovaza label. 

The last step for Amarin will be suing the FDA using the argument that the company has a first amendment right to discuss clinical data with doctors. 

<P/> <I>-- Reported by Adam Feuerstein in Boston.</I>

<P/>Follow Adam Feuerstein on <B><A HREF="http://twitter.com/adamfeuerstein" target="new">Twitter</A></B>.

Adam Feuerstein writes regularly for TheStreet. In keeping with company editorial policy, he doesn't own or short individual stocks, although he owns stock in TheStreet. He also doesn't invest in hedge funds or other private investment partnerships. Feuerstein appreciates your feedback; click here to send him an email.

Check Out Our Best Services for Investors

Action Alerts PLUS

Portfolio Manager Jim Cramer and Director of Research Jack Mohr reveal their investment tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
Quant Ratings

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
Stocks Under $10

David Peltier uncovers low dollar stocks with serious upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
14-Days Free
Try it NOW
Only $9.95
Try it NOW
14-Days Free
Try it NOW

Check Out Our Best Services for Investors

Dividend Stock Advisor

David Peltier identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Updates with exact steps to take - BUY, HOLD, SELL
Trifecta Stocks

Every recommendation goes through 3 layers of intense scrutiny—quantitative, fundamental and technical analysis—to maximize profit potential and minimize risk.

Product Features:
  • Model Portfolio
  • Intra Day Trade alerts
  • Access to Quant Ratings
Options Profits

Our options trading pros provide over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.

Product Features:
  • Actionable options commentary and news
  • Real-time trading community
Try it NOW
Try it NOW
Try it NOW
To begin commenting right away, you can log in below using your Disqus, Facebook, Twitter, OpenID or Yahoo login credentials. Alternatively, you can post a comment as a "guest" just by entering an email address. Your use of the commenting tool is subject to multiple terms of service/use and privacy policies - see here for more details.
Submit an article to us!
SYM TRADE IT LAST %CHG
AMRN $2.41 0.00%
GSK $47.02 0.00%
AAPL $123.25 0.00%
FB $83.30 0.00%
GOOG $548.34 0.00%

Markets

DOW 17,712.66 +34.43 0.19%
S&P 500 2,061.02 +4.87 0.24%
NASDAQ 4,891.2190 +27.8570 0.57%

Partners Compare Online Brokers

Free Reports

Free Newsletters from TheStreet

My Subscriptions:

After the Bell

Before the Bell

Booyah! Newsletter

Midday Bell

TheStreet Top 10 Stories

Winners & Losers

Register for Newsletters
Top Rated Stocks Top Rated Funds Top Rated ETFs