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's Fish Oil Pill Faces Even More Exclusivity Risks

BEDMINSTER, NJ ( TheStreet) -- More market exclusivity woes for Amarin (AMRN) and its prescription fish oil pill Vascepa.

I was speaking with an institutional investor last week who made money on Amarin when Vascepa was still in clinical development and known as AMR101. He's been out of Amarin for awhile but was taking another look with the stock trading near a 16-month low. While digging into the controversy over Amarin's inability to win five years of marketing exclusivity for Vascepa as a New Chemical Entity (NCE), it dawned on him that FDA had also refused (so far) to grant the drug three years of market exclusivity as a New Molecular Entity (NME.)

NME exclusivity is supposed to be the consolation prize awarded by FDA to new drugs refused the preferred NCE status. But not in this case. If you look at the FDA Orange Book, Vascepa is listed as having "no unexpired exclusivity." No NCE. No NME.

By now, most people believe FDA is unwilling to grant NCE status to Vascepa because its active moiety, or active ingredient, is the same as GlaxoSmithKline's (GSK - Get Report) Lovaza. But my investor source believes FDA is also refusing to grant Vascepa three years of marketing exclusivity as an NME because Vascepa is approved for the same indication -- triglyceride reduction in patients with very high ( >500mg/dl) hypertriglyceridemia -- previously awarded to Lovaza. (These are the patients who encompassed Amarin's "Marine" phase III trial.)

FDA could grant Vascepa NME status and three years of marketing exclusivity for the larger, mixed dyslipidemia "Anchor" indication. Lovaza is not approved for these patients so there is no overlap.

But here's where Amarin runs into big trouble even if Vascepa wins three years of marketing exclusivity for the "Anchor" indication. The absence of NME exclusivity for the "Marine" patients makes it easier for generic versions of Vascepa to reach the market. And if a generic Vascepa is approved -- assuming a label for "Marine" very high triglyceride patients only -- doctors (with the encouragement of insurance companies) will be able to prescribe the less expensive generic for all patients, including the mixed dyslipidemia "Anchor" patients.
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 $1.94 0.00%
GSK $43.33 0.09%
AAPL $95.32 1.80%
FB $117.60 -0.82%
GOOG $695.17 -0.44%


Chart of I:DJI
DOW 17,771.66 -119.50 -0.67%
S&P 500 2,063.80 -17.63 -0.85%
NASDAQ 4,773.2230 -44.3710 -0.92%

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs