* Company does not expect approval in 2014
* Shares fall about 11 pct
(Adds analysts' comment, details, shares)
By Natalie Grover
May 2 Acorda Therapeutics Inc said the
U.S. Food and Drug Administration rejected its nasal form of the
current standard therapy for epilepsy patients who experience
The biotechnology company's shares fell as much as 11
percent after it said that it does not expect the treatment to
receive regulatory approval this year.
Analysts expressed surprise at the agency's decision as the
drug's active ingredient is diazepam, the decades-old compound
commonly sold as anti-anxiety tablet Valium.
Piper Jaffray analyst David Amsellem said the drug's
marketing filing was also low risk as it allowed Acorda to
present data including research not conducted by or for the
The application referenced Valeant Pharmaceuticals'
Diastat - the current standard-of-care for epilepsy
accompanied by so-called cluster seizures - which is
administered rectally via a syringe.
The drug, Plumiaz, has a orphan drug status, providing the
company certain incentives including a period of marketing
Acorda did not disclose the reason for the rejection, but
said it planned to resubmit the application.
Aegis Capital analyst Raghuram Selvaraju said he expected
that the FDA would not mandate additional efficacy trials.
"We believe (Acorda) will refile (the marketing application)
by 2015 and hopefully get approval by the end of the year,"
Selvaraju said. He projected annual sales of $30 million to $60
million for the drug.
Selvaraju said he did not consider the drug would be a major
growth driver in the near term, but would have complemented
Acorda's existing central nervous system product mix.
The company currently markets Amypyra, used to improve
walking in people with multiple sclerosis; Qutenza for
post-shingles nerve pain and Zanaflex for use in spasticity.
Acorda is also testing Ampyra, which accounts for the bulk
of its revenue, for use in post-stroke deficit, a market
Selvaraju projects could be 10 times the size of the drug's MS
About 175,000 of the 2.8 million people in the United States
with epilepsy experience cluster seizures, Acorda said.
Epilepsy is a neurological condition that produces seizures,
which occur when a brief, strong surge of electrical activity
affects part or all of the brain.
The Ardsley, New York-based company's shares were down about
10 percent to $32.47 in afternoon trade on the Nasdaq on Friday.
(Editing by Sriraj Kalluvila)