Acorda Therapeutics (Nasdaq: ACOR)
illustrates why investing in small biotech companies requires
nerves of steel.
In the past 12 months, its stock has bounced between the
mid-teens and high $20s. Today, it is back in the mid-$20s --
up about 50% -- after a scientific advisory panel to the Food
and Drug Administration endorsed Acorda's drug to improve the
walking abilityof people with multiple sclerosis.
The advisory committee, acting Wednesday while trading in
the stock was halted, voted 12-1 that the drug, Amaya, is
effective and 10-2 with one abstention that the drug is safe.
The panel said Acorda should evaluate the drug at lower
doses, adding that Acorda could do so after FDA approval.
Although Amaya isn't designed to treat the disease, FDA
approval would make it the first oral MS drug. So far, all
marketed drugs for treating MS must be injected or infused,
such as
Teva Pharmaceutical 's (Nasdaq: TEVA)
Copaxone.
Several companies,including
Novartis (NYSE: NVS) and Germany's Merck
KGaA, are developing oral medicines to treat MS.
Don't expect immediate action
The FDA isn't required to follow the advice of its
outside advisors, but it usually does so. The target date for
the FDA's verdict is Oct. 22. However, because Amaya can
cause severe side effects, I believe the FDA will take more
time to study it. In clinical trials, serious side effects
included a relapse of MS, convulsions, and four
"seizure-related events."
The FDA also will need time to review a
risk evaluationand mitigation strategy (REMS) program
from Acorda. These are an increasingly common FDA requirement
to ensure safe prescribing and use of drugs with potentially
severe side effects.
Acorda licenses Amaya from
Elan (NYSE: ELN), which continues to
manufacture the drug. Acorda
recently signedan agreement with
Biogen Idec (Nasdaq: BIIB) giving it
marketing rights in Europe. Biogen Idec is expected to seek
European Union approval early next year.
Investors react ... and overreact
The market's reaction today stood in sharp contrast to
Oct. 9, when an FDA staff report raised questions about
Amaya's effectiveness even though the drug had met the goals
of clinical trials. Continued... |