This Day On The Street
Continue to site
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 NCE Delay is Bad News For Fish-Oil Pill

BEDMINSTER, NJ ( TheStreet) --The U.S. Food and Drug Administration approved Amarin's (AMRN) Vascepa on July 26 yet almost two months later, regulators still can't decide if the prescription fish-oil pill deserves five years of market exclusivity as a New Chemical Entity (NCE).

The latest "non decision" on Vascepa's NCE status was disclosed Monday night in an Amarin regulatory filing.

Amarin has a serious problem here, folks.

My read of the tea leaves: FDA decided long ago that Vascepa's chemical structure -- its "active moiety" -- is too similar to GlaxoSmithKline's (GSK - Get Report) Lovaza. Therefore, Vascepa can't be granted NCE status and the much-coveted five years of market exclusivity that goes along with the designation. The FDA's consolation prize is three years of exclusivity for Vascepa, but that also means Amarin will likely face almost immediate generic challenges to the drug's patents.

If FDA has made up its mind internally to deny NCE status to Vascepa, why not just come out with the news already? Because Amarin appears to be doing all it can to stave off the bad news, including deploying a small army of lawyers to lobby, cajole and strong-arm FDA to reverse its decision. Remember the June meeting between Amarin and FDA?

That's the only logical explanation for this ridiculous delay.

Amarin bulls counter with two arguments: 1) NCE status is irrelevant because Amarin's recent Vascepa patents wins are more important; or 2) the recent Vascepa patent wins will persuade FDA to grant the drug NCE status.

If NCE status isn't important, why is everyone so keenly focused on it? And why are Amarin shares still trading at a discount to where the stock stood on the day of Vascepa's approval?

Moreover, granted patents have no role in the FDA's NCE decision-making process, which is described in the agency's regulations, says John Tucker, an analyst at BioMedTracker.

Tucker, a chemist by training, believes Vascepa doesn't deserve NCE status. Nor does Dr. Andrew Goodwin of Chimera Research Group. His argument against can be found here.

I used to doubt these guys, but no longer. I think they're right.
1 of 2

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
Real Money

More than 30 investing pros with skin in the game give you actionable insight and investment ideas.

Product Features:
  • Access to Jim Cramer's daily blog
  • Intraday commentary and news
  • Real-time trading forums
Only $49.95
14-Days Free
14-Days Free
AMRN $2.05 -0.49%
GSK $39.86 0.91%
AAPL $110.78 0.36%
FB $93.69 1.80%
GOOG $638.06 1.80%


Chart of I:DJI
DOW 16,776.43 +304.06 1.85%
S&P 500 1,987.05 +35.69 1.83%
NASDAQ 4,781.2640 +73.4890 1.56%

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs