If you like the thrills of make-or-break biotech investing, watch for the Oct. 14 Food and Drug Administration advisory committee's review of a multiple sclerosis drug from Acorda Therapeutics
Unlike other drugs on the market, Acorda isn't claiming that its drug, Amaya, modifies the disease. Amaya's goal is to improve the MS patient's walking ability. Also, unlike existing drugs, Amaya is a sustained-release tablet.
Several companies, including Novartis
The advisory panel's review of Amaya should provide these companies -- and investors -- with insight about key issues facing oral MS drugs. And Amaya could be a big hit. A recent report by Merriman Curhan Ford says a best-case scenario could yield peak annual sales of $1 billion in 2015.
Acorda needs Amaya. The company sells only one drug -- Zanaflex for the management of spasticity, which provided modest sales of $29.4 million for the first half of 2009. Aside from Amaya, there's nothing in the research and development pipeline sufficiently advanced for investors to use to make an investment decision.
As for the advisory-panel vote, the FDA doesn't have to follow the recommendations of its outside advisors, but it usually does.
For Amaya, the agency’s PDUFA date -- the timetable for making a decision -- occurs eight days after the advisory panel meets. For a first-in-class drug like Amaya, there’s a good chance the FDA will require more time.
It's also possible Acorda will have to institute a risk evaluation and mitigation strategies (REMS) program, an increasingly frequent FDA requirement to ensure certain drugs are taken and administered safely.
Sharing revenues, expanding markets
If the FDA approves Amaya, which also is called fampridine-SR, Acorda will have to share its success with Elan, which manufactures the drug for Acorda.
Thanks to a recent agreement, Biogen Idec will commercialize Amaya outside the U.S. in return for a $110 million up-front payment, milestone payments of up to $400 million based on regulatory and/or sales successes, and royalties tied to sales. Biogen Idec is expected to seek European Union approval for Amaya early next year.
Acorda approaches the FDA advisory committee with some good clinical-trial data as well as some skepticism. Sell-side analysts favor Acorda with nine "buy" and two "hold" ratings. However, its one-star status at Motley Fool CAPS puts Acorda on the deathbed stocks list.
Soon, we'll know whether to trust the opinion of experts or the wisdom of crowds.
Check out this medical Foolishness:
Fool contributor Robert Steyer doesn't own shares of any companies cited in this story. Elan is a Motley Fool Rule Breakers pick. Novartis is a Global Gains recommendation. The Fool has a disclosure policy.