HAWTHORNE, NY (
) --In the end, the vote wasn't even close. By a 12-1 margin, a panel of experts convened by the Food and Drug Administration recommended approval of a drug from
that helps multiple sclerosis patients to walk.
With the panel recommendation set, Acorda now waits for the final FDA decision on its drug, known as Amaya.
The positive outcome of the advisory panel meeting Wednesday came despite a more skeptical review of Amaya by the FDA's own medical reviewers. That review was posted to the agency's web site Friday and caused shares of Acorda to fall going into the panel meeting.
In a signal that the FDA wasn't necessarily of one mind on the risk-benefit of Amaya, however, the agency added an unusual disclaimer to its own review stating that the negative conclusions expressed did not necessarily reflect the overall view of the FDA.
In another 12-1 vote, the panel did recommend that Acorda test a lower dose of the drug, but by a 10-2 margin, the panel said the low-dose studies could be done after Amaya was approved.
Much discussion was given to a risk-management plan for Amaya, which would warn patients and doctors about the drug's safety risks, including seizures.
The final decision on Amaya's approval is made by FDA, which has a deadline of Oct. 22. That decision will likely be delayed, however, given the timing of Wednesday's panel and the likely need to finalize discussions over the drug's labeling and risk-management plan. An approval delay into early next year may not hurt Acorda's stock price since it is widely expected.
is the co-marketing partner for Amaya.
Acorda shares were halted Wednesday at $16.74.
Tamiflu Star of Roche's Third-Quarter Results
Swiss drug giant
, now reporting combined results with its U.S.-based
unit, reported a 10% rise in third-quarter sales spurred by extra-heavy demand for the flu drug Tamiflu.
But minus Tamiflu, Roche drug sales, most notably the cancer drugs Avastin, Herceptin and Rituxan, all fell short of expectations in the quarter. Biogen Idec, which receives Rituxan royalies, may see the ill-effects of that drug's shortfall during Thursday's trading session.
received royalties on Tamiflu sales, so that stock may benefit Thursday because Roche raised Tamiflu sales guidance for 2009 and 2010.
Protalix Reports Positive Gaucher Drug Results
announced positive top-line results from a phase III study of Uplyso in patients with Gaucher disease. The study met its primary endpoint of reducing spleen volume after nine months of treatment for both doses of Uplyso tested, according to the company.
Protalix plans to complete an approval filing to the Food and Drug Administration by the end of the year. The FDA is already allowing Protalix to treat U.S. Gaucher patients with Uplyso due to a shortages of an approved, competing drug sold by
Targacept Drug Data Expected Tonight
As a reminder, researchers will be presenting detailed results from a phase II study of
at a medical meeting today. The presentation is scheduled for 6 PM EDT.
-- Reported by Adam Feuerstein in Boston
Adam Feuerstein writes regularly for TheStreet.com. In keeping with TSC's editorial policy, he doesn't own or short individual stocks, although he owns stock in TheStreet.com. He also doesn't invest in hedge funds or other private investment partnerships. Feuerstein appreciates your feedback;
to send him an email.