said Monday that a second late-stage study of its Fampridine-SR improved walking speed of multiple sclerosis patients with no new safety risks.
Shares of the biotech company rose in premarket trading to open up 21% at $26.13 Monday morning.
The Hawthorne, N.Y., company said the 240-patient study met its primary endpoint of consistent improvement in walking speed. The study looked at patients between the ages of 18 and 70 with a definite diagnosis of MS and some degree of walking disability. In a timed 25-foot walk, 42.9% of patients in the Fampridine arm showed improvement vs. 9.3% of patients in the placebo arm. The results were statistically significant.
Acorda said that in the recent study adverse events were generally mild to moderate and largely consistent with the safety profile observed in previous studies of Fampridine-SR in people with MS.
Notably, there were instances of no seizures in the Fampridine arm of the study, allaying investor safety fears. "We note that interferons and Copaxone (used in approximately 60-65% of Fampridine-SR trials) are known to lower the threshold for seizure," wrote JP Morgan analyst Geoffrey Meacham in a note to investors. "However, there has been no signal for increased seizures at 10mg twice daily, and as expected, the rate appears to be 1/100 patient years, in line to below that of ABCRs." Thus, he sees the Fampridine-SR program as now de-risked, upping the value of the franchise and Acorda.
"We believe that, subject to FDA
Food and Drtug Administration review, the results of our two phase 3 trials are adequate to support an NDA
new-drug application. We expect to submit this application in the first quarter of 2009 and plan to request priority review," said Ron Cohen, CEO of Acorda Therapeutics, in a release.
JP Morgan's Meacham said in his Monday note that peak sales in the U.S. could be in the $500 million range with worldwide peak sales reaching $800 million pending a strong U.S. launch. He has an overweight rating.
Acorda is developing the sustained-release drug with manufacturing partner
Acorda shares were up $6.80, or 31.5%, to $28.36 in recent trading Monday, while Elan was down a slight 2 cents, or 0.2% at $25.
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