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 Loses Bid for Vascepa 5-Year Market Exclusivity

The question of New Chemical Entity (NCE) status for Amarin's (AMRN) prescription fish-oil pill Vascepa was finally settled on Friday. Like all of Amarin's recent regulatory decisions, this one also went against the company.

The FDA finally told Amarin that Vascepa would not be granted the five years of market exclusivity that comes with NCE status. Instead, FDA said Vascepa was a New Product (NP) entitled to three years of exclusivity.

The "NCE or no NCE" question has been hanging over Amarin since before Vascepa was approved on July 26, 2012.

The product's market exclusivity now expires on July 26, 2015. After that date, generic drug makers can seek FDA approval to make their own versions of Vascepa. Amarin will almost certainly sue any generic drug maker who files and will receive an automatic 30-month extension of Vascepa exclusivity. Amarin believes patents on Vascepa, some of which extend out to 2030, protect the product beyond the expiration of market exclusivity.

Must Read: Vertex Pharma Swaps Endpoints in Key Cystic Fibrosis Studies

Amarin may never face a generic challenge to Vascepa because the product's current sales are so small. The company is expected to report fourth-quarter and 2013 revenue of $11.2 million and $27.38 million, respectively, according to S&P CapitalIQ consensus estimates.

Analysts have Amarin growing Vascepa revenue to $71 million this year and $115 million in 2015.

To put those estimates in perspective, prior to Amarin's approval, the Vascepa consensus sales estimate for 2014 was almost $450 million, according to S&P CapitalIQ.

More than the lack of NCE, Amarin's biggest problems is its inability to market Vascepa to the broader swath of patients with mixed dyslipidemia -- the so-called "Anchor" patient population. As those who have followed Amarin are well aware, an FDA advisory panel voted overwhelmingly to recommend against expanding Vascepa's label until the company produces data demonstrating improvement in cardiovascular outcomes.

While FDA hasn't made a formal approval decision yet, nothing the agency has done suggests a willingness to be lenient on Amarin and go against the negative decision of the panel.

Without an expanded label, Amarin is forced to market Vascepa only to patients with extremely high triglycerides -- a task the company isn't doing very well.

Amarin shares closed Friday at $1.86. The stock has lost 88% of its value since Vascepa was approved compared to a 100% gain in the Nasdaq Biotechnology Index over the same time period. 

AMRN Chart
AMRN data by YCharts

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.


Chart of I:DJI
DOW 17,773.64 -57.12 -0.32%
S&P 500 2,065.30 -10.51 -0.51%
NASDAQ 4,775.3580 -29.9330 -0.62%

Adam's Tweets

Select the service that is right for you!

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
  • Weekly roundups
Real Money Pro

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
Trifecta Stocks

Trifecta Stocks analyzes over 4,000 equities weekly to find the elite 1% of stocks that pass rigorous quantitative, fundamental and technical tests.

Product Features:
  • Model portfolio
  • Trade alerts
  • Recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
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
  • Weekly roundups
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
  • Upgrade/downgrade alerts
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
  • Alerts when market news affect the portfolio
  • Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
Growth Seeker

Chris Versace, using sophisticated stock screening and fundamental research, identifies potentially explosive small and mid-cap stocks.

Product Features:
  • Model portfolio
  • Small-cap and mid-cap focus
  • Intraday trade alerts
  • Weekly roundups
Daily Swing Trade

Master swing trader Alan Farley uses his sophisticated software screens to review thousands of stocks each day for you, to find just the handful that meet his demanding criteria.

Product Features:
  • Daily commentary and coaching on swing trading
  • Technical charts and analysis
Top Rated Stocks Top Rated Funds Top Rated ETFs