Amicus, Shire Team on Rare Gene R&D
Amicus will receive an initial licensing payment of $50 million and is eligible to receive an additional $150 million tied to clinical and regulatory approvals, $240 million in sales-based milestones and tiered double-digit royalties. According to the agreement, U.K.-based Shire will have the rights to commercialize the products outside of the U.S., and New Jersey-based Amicus will have the right to commercialize inside the U.S.
The companies will share equally the costs toward global approval of the Amicus compounds: Amigal, Plicera and AT2220. Amigal is in phase II development for Fabry disease, Plicera is in phase II clinical trials for Gaucher disease, and AT2220 is in phase I trials for Pompe disease. (Shire also owns Replagal to treat the genetic disorder Fabry disease.)
The diseases belong to a class of lysosomal storage disorders, which are caused by a mutation in the genes that control enzymes responsible for breaking down lipids, sugars and other materials that can build up to harmful levels in the body.Genzyme (GENZ) makes Cerezyme for Gaucher disease and said in October that it completed enrollment for the phase II trial of an oral therapy for Gaucher disease and has requested a meeting with the FDA to discuss an expedited development strategy, hoping to bring the drug to market in three to four years. Genzyme also reported $53.6 million in sales from Myozyme therapy for Pompe disease and $104.6 million in sales of Fabrazyme, a recombinant form of a human enzyme to treat Fabry disease. It submitted an application to the FDA for approval of a larger-scale manufacturing process to supply Myozyme in the U.S., and it expects a decision from the agency in the first quarter of next year. Amicus shares, which surged about 12% in early trading, were up 53 cents, or 3.3% at $16.61 around midday.
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
Access the tool that DOMINATES the Russell 2000 and the S&P 500.
- Buy, hold, or sell recommendations for over 4,300 stocks
- Unlimited research reports on your favorite stocks
- A custom stock screener
- Upgrade/downgrade alerts
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
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 Plus 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