Results from the phase III trial showed that AP failed to achieve statistically significant improvement compared to placebo in patients suffering from spasticity due to multiple sclerosis (MS).
AP’s failure in the phase III study is a major disappointment and setback for the company.
The company was looking to submit a new drug application (:NDA) for AP in the US at the end of 2013.
However, XenoPort has now decided to terminate any further studies on this program.
Shares were down 15.2% on the news.
We believe that the successful development and commercialization of AP would have boosted XenoPort’s portfolio which currently comprises only one approved drug, Horizant.
Going forward, XenoPort will shift its focus to its fumarate product candidate XP2389 along with investing in the commercialization of its prime drug, Horizant.
We note that XenoPort obtained the development and commercialization rights on Horizant in the US from GlaxoSmithKline plc (GSK), effective May 1, 2013, following the termination of their collaboration agreement in Nov 2012.
Horizant is approved in the US for the treatment of moderate-to-severe primary restless legs syndrome (:RLS) as well as for the management of postherpetic neuralgia (:PHN) in adults.
However, Horizant faces stiff competition for both indications. Pfizer’s (PFE) Neurontin competes with Horizant for the PHN indication.
XenoPort currently carries a Zacks Rank #3 (Hold). Right now, Anika Therapeutics, Inc. (ANIK) looks attractive with a Zacks Rank #1 (Strong Buy).
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