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
See Cramer's multi-million dollar portfolio for FREE and get his new book Get Rich Carefully! Learn More

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) 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.

Stock quotes in this article: AMRN, GSK 

Select the service that is right for you!

COMPARE ALL SERVICES
Action Alerts PLUS
Try it NOW

Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
  • Weekly roundups
TheStreet Quant Ratings
Try it NOW
Only $49.95/yr

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
  • Upgrade/downgrade alerts
Stocks Under $10
Try it NOW

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

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
  • Weekly roundups
Dividend Stock Advisor
Try it NOW

Jim Cramer's protege, 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
  • Alerts when market news affect the portfolio
  • Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
Real Money Pro
Try it NOW

All of Real Money, plus 15 more of Wall Street's sharpest minds delivering actionable trading ideas, a comprehensive look at the market, and fundamental and technical analysis.

Product Features:
  • Real Money + Doug Kass Plus 15 more Wall Street Pros
  • Intraday commentary & news
  • Ultra-actionable trading ideas
Options Profits
Try it NOW

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

Product Features:
  • 100+ monthly options trading ideas
  • Actionable options commentary & news
  • Real-time trading community
  • Options TV
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.
DOW 16,438.65 +13.80 0.08%
S&P 500 1,866.98 +4.67 0.25%
NASDAQ 4,102.5290 +16.3040 0.40%

Brokerage Partners

Rates from Bankrate.com

  • Mortgage
  • Credit Cards
  • Auto
Advertising Partners

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