This Day On The Street
Continue to site
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

Amarin Finally Admits FDA Discord Over Vascepa Market Exclusivity

BEDMINSTER, NJ ( TheStreet) -- Amarin (AMRN) included some interesting new language in an 8-K filed Wednesday regarding Vascepa and the long-delayed FDA decision on New Chemical Entity (NCE) status:

"While Amarin continues to believe its arguments in support of an NCE determination for Vascepa are strong, the FDA may not agree with Amarin's arguments."

Vascepa was approved in late July and yet there's still no FDA decision on the much-needed five years of market exclusivity that comes with NCE designation. [For those keeping score at home, we're on NCE decision delay No. 4.]

What's different this time, however, is that Amarin appears to be finally acknowledging the big risk: FDA isn't convinced Vascepa deserves NCE designation because the active ingredient in the prescription fish-oil pill is too similar to GlaxoSmithKline's (GSK - Get Report) Lovaza.

The previous two Amarin 8-Ks dealing with Vascepa NCE decision delays did not include the above-mentioned sentence.

Amarin has warned investors about the risks related to Vascepa and NCE designation in previous quarterly SEC filings using the following language:

"We cannot assure you that FDA will make this determination in a timely manner, or that we will be granted NCE exclusivity."

There's a subtle difference but significant.

Amarin also states in Wednesday's 8K:

"As previously disclosed, Amarin continues to anticipate commercial launch of Vascepa in the first quarter of 2013, and continues to consider three potential paths for the marketing and sale of the product: an acquisition of Amarin, a strategic collaboration, or self-commercialization, the latter of which could include third-party support. As previously disclosed, Amarin is now focused on continued commercial preparations for Vascepa which includes, but is not limited to, finalizing the introduction of Vascepa to managed care plans to gain formulary access, building up inventory levels, hiring key personnel and coordinating other pre-launch marketing activities."

The likelihood that Amarin launches Vascepa on its own grows as the NCE decision delay continues. Amarin bulls continue to insist that NCE status is irrelevant and that a takeover at a big premium is in the works.

Amarin shares are down 8% to $10.89 in Wednesday trading, which means the stock has lost almost 30% of its value since Vascepa was approved. I'd say the market doesn't agree with the Amarin bull story.

-- Reported by Adam Feuerstein in Boston.

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
Only $9.95
14-Days Free
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
SYM TRADE IT LAST %CHG
AMRN $2.20 0.00%
GSK $43.46 -0.11%
AAPL $114.64 -3.21%
FB $94.06 -0.08%
GOOG $630.13 -0.17%

Markets

Chart of I:DJI
DOW 17,550.69 -47.51 -0.27%
S&P 500 2,093.32 -4.72 -0.22%
NASDAQ 5,105.5460 -9.8360 -0.19%

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs