Amylin, which currently markets twice-daily Byetta with third partner Eli Lilly (LLY), is also up against a competitive time crunch to get its once-weekly product approved. Its competitor Novo Nordisk (NVO) has already submitted its application for a once-daily injection and pending the outcome of a panel in March, could have its product approved by mid-2009.
Amylin isn't the first company to face pressure from the FDA to show that products manufactured at separate plants are the same. Genzyme's (GENZ) Myozyme produced at a new, larger-scale manufacturing facility was considered a different product than the already-approved product, causing unforeseen regulatory delays.
The potential setback disclosed in the Alkermes SEC filing on Tuesday isn't Amylin's first for the year. Amylin's shares have been depressed on reports of pancreatitis, and in some cases death, of patients taking its twice-daily Byetta, although there is no known link between the drug and pacreatitis.
Eastbourne Capital, which owned a nearly 13% stake in Amylin as of late August, said earlier in the week that it intends to hold discussions with management, other shareholders and third parties, regarding actions that could enhance shareholder value, including a possible sale of the company.For more stories like this, check out our Biotech Stock section.
Select the service that is right for you!COMPARE ALL SERVICES
Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.
- $2.5+ million portfolio
- Large-cap and dividend focus
- Intraday trade alerts from Cramer
- Weekly roundups
Jim Cramer's protege, David Peltier, identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.
- Diversified model portfolio of dividend stocks
- Alerts when market news affect the portfolio
- Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
24/7 market commentary from Jim Cramer and 20+ veteran Wall Street gurus. Get access to the latest trading ideas on stocks, options, and ETFs as well as a real-time forum to see the pros exchanging their investment ideas.
- Jim Cramer + 20 Wall Street pros
- Intraday commentary & news
- Real-time trading forum
- Actionable trade ideas
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.
- Real Money + Doug Kass + 15 more Wall Street Pros
- Intraday commentary & news
- Ultra-actionable trading ideas
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.
- 100+ monthly options trading ideas
- Actionable options commentary & news
- Real-time trading community
- Options TV