Axsome Therapeutics Inc. entered into an agreement for an exclusive U.S. license to Pfizer Inc.'s clinical and nonclinical data, intellectual property for reboxetine, and the license to develop and market esreboxetine in the U.S.
New York-based Axsome is developing reboxetine, or AXS-12, for the treatment of narcolepsy. The sleep disorder is characterized by excessive sleepiness, sleep paralysis, hallucinations and episodes of cataplexy, or a partial or total loss of muscle control often triggered by a strong emotion such as laughter.
The drug significantly reduced the number of cataplexy attacks in patients in a mid-stage study and also holds orphan-drug status in the U.S. Pfizer markets reboxetine outside the U.S. for treating depression, but it is not approved in the U.S. for any indication.
Esreboxetine, or AXS-14, is being developed as a potential treatment of fibromyalgia — a disorder characterized by widespread musculoskeletal pain accompanied by fatigue, sleep, and memory and mood issues. Under the agreement, Axsome will solely be responsible for developing AXS-14 for any indication.
Under the agreement, Pfizer will receive an up-front cash payment of $3 million, with up to $323 million in regulatory and sales milestones as well as mid-single to low double-digit royalties on future sales.
In addition, Pfizer will receive $8 million worth of Axsome's common stock and will have the right of first negotiation on any potential future strategic transactions involving the drugs.
Axsome will receive the license to Pfizer's data for AXS-12 and AXS-14, encompassing a full range of nonclinical studies, short-term and long-term clinical studies involving more than 5,000 patients. This includes results from a phase 2 and a phase 3 clinical trial of AXS-14 in the treatment of fibromyalgia in which the drug helped patients by significantly reducing pain.