Cowen: Acorda Therapeutics Not Worried About Civitas Therapeutics' New Parkinson's Drug

November 20, 2014

By Riley McDermid, BioSpace.com Breaking News Sr. Editor

Biopharmaceutical company Acorda Therapeutics said its new acquisition of Civitas Therapeutics is as “hand in glove” as a deal could be and it is not worried about the safety of its flagship Parkinson’s drug, said Phil Nadeau, a biotech analyst with Cowen and Co., on Thursday.

Acorda was hosted by Cowen earlier this week and management executives Acorda's Chief Executive Officer Ron Cohen, Chief Business Development Officer Andrew Hindman, and Senior Vice President of Corporate Communications Tierney Saccavino were all present to talk about the company’s near-term strategy.

Acorda recently acquired privately held Civitas for $525 million, thus obtaining global rights to CVT-301, a Phase III candidate for the treatment of Parkinson disease OFF episodes.

“Management is excited about the Civitas, noting that it is as close to a ‘hand in glove’ acquisition as one can find. For the past several years ACOR's stock has been held back by a lack of visible growth drivers,” wrote Nadeau in a note to investors. “With this acquisition, ACOR has added a promising Phase III candidate to its pipeline. Civitas' neurology focus fits well with Acorda's core research and development efforts in specialty neurology.”

Nadeau said that anagement noted that as Acorda “already fields” a neurology salesforce in the U.S., CVT-301 can be commercialized with little additional infrastructure. Still, concerns about the safety of the drug remain, after the U.S. Food and Drug Administration's concern about pulmonary-delivered drugs for non-respiratory conditions. Management attempted to address those worries Tuesday.

“Acorda noted that it diligenced CVT-301's pulmonary safety extensively, and could find no worrisome signals. In particular, Acorda has much pulmonary function data on CVT-301 as well as on the underlying powder technology (from the Lilly-Alkermes collaboration on insulin) and found no impact on pulmonary function,” said Nadeau.

“Moreover, Acorda has examined the correspondence between Civitas and the FDA. Acorda was impressed by the general tenor of the interactions,” he wrote. “Management appears confident that the FDA is not overly concerned by CVT-301's pulmonary delivery (or any other aspect of its safety profile), and that CVT-301's Phase III program will be sufficient to support FDA approval.”