Acorda Therapeutics, Inc. (ACOR) recently announced data from a phase I study evaluating its epilepsy candidate, diazepam nasal spray. The company is developing diazepam nasal spray for treating epilepsy patients who experience cluster seizures/acute repetitive seizures. The data was presented at the 65th annual meeting of American Academy of Neurology.
The open-label crossover phase I study, which enrolled 24 healthy volunteers compared the use of a single dose of 20 mg diazepam nasal spray with a single dose of 20 mg diazepam rectal gel. Similar safety and tolerability profile was observed in both arms of the study. Additionally, diazepam nasal spray demonstrated comparable plasma bioavailability to diazepam rectal gel.
Currently, Acorda is preparing to submit a 505(b)(2) type new drug application (:NDA) for diazepam nasal spray. The company plans to submit the regulatory application to the US Food and Drug Administration (:FDA) in 2013.
We note diazepam nasal spray was added to Acorda’s neurology pipeline following the acquisition of privately-held Neuronex, Inc. in Dec 2012.
We are pleased with the company’s efforts to develop its pipeline. However, most of the candidates are in early stages of development. Consequently they are quite a few years away from entering the market, if at all. We are also concerned about Acorda’s dependence on Ampyra (improve walking in patients with multiple sclerosis), which accounts for the bulk of the company’s net product revenues, for growth.
While we are encouraged by the improvement in Ampyra’s performance in the fourth quarter of 2012 and the 2013 Ampyra guidance, it remains to be seen whether the trend can be sustained.
Acorda carries a Zacks Rank #4 (Sell) in the short run. Stocks that currently look attractive in the pharma space include companies like Cytokinetics, Inc. (CYTK) , Osiris Therapeutics, Inc. (OSIR) and Agenus Inc. (AGEN) . While Cytokinetics and Osiris are Zacks Rank #1 (Strong Buy) stocks, Agenus is a Zacks Rank #2 (Buy) stock.
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