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GEN News Highlights : Jan 24, 2012

Santhera Regains Global Rights to Parkinson Disease Drug Fipamezole from Ipsen

New agreement gives Ipsen call option to obtain exclusive worldwide license to clinical-stage candidate.

Santhera Pharmaceuticals and Ipsen have amended their existing agreement for the development and commercialization of Santhera’s clinical-stage Parkinson disease drug, fipamezole. Ipsen is returning to Santhera rights to all territories outside of North America and Japan, in exchange for milestone payments and royalties based on future partnering and commercial success.

Santhera thus effectively regains worldwide rights to the drug, including the freedom to license the program to a third party. The new deal does include a call option allowing Ipsen, under certain circumstances, to obtain an exclusive, worldwide license itself, in return for milestone and royalty payments.

Fipamezole is a selective adrenergic alpha-2 receptor antagonist, which is in development for managing levodopa-induced dyskinesia in Parkinson disease patients. Santhera has already successfully completed two Phase II trials demonstrating the efficacy and safety of the drug. However, the firm admits fipamezole won’t be top of its development priorities list.

“In the short term, the focus of our investments remains on our lead product Catena® and its multiple product opportunities in neuromuscular and mitochondrial orphan indications,” remarks Thomas Meier, Santhera CEO. “However, fipamezole continues to be a valuable asset in Santhera’s late-stage clinical pipeline.”

Santhera and Ipsen signed their original fipamezole deal back in September 2010. With €13 million up front, Ipsen obtained rights to fipamezole outside the U.S., Canada, and Japan.