Agency has until mid October to review NDA for lorcaserin.
Eisai is paying Arena Pharmaceuticals’ $50 million up front for exclusive rights to commercialize the latter’s obesity and weight-management drug, lorcaserin, in the U.S. The serotonin 2C receptor agonist is currently undergoing review by FDA, and a Prescription Drug User Fee Act (PDUFA) date of October 22nd has been assigned.
Under the terms of the deal Arena could receive up to another $90 million in milestone payments on regulatory approval of lorcaserin and delivery of the product for launch. The drug will be manufactured by Arena at its Swiss facility, and Eisai will be responsible for marketing and distribution in the U.S. Arena will in addition be eligible for another $1.6 billion in the form of one-time purchase price adjustment payments based on annual sales levels of lorcaserin plus potentially $70 million in regulatory and development milestone payments.
Arena’s Phase III program for lorcaserin consisted of two pivotal trials, Bloom and Blossom, which included nearly 7,200 patients. Both studies found lorcaserin treatment for up to two years resulted in statistically significant weight loss in either overweight or obese patients with or without comorbid conditions such as hypertension, cardiovascular disease, or glucose intolerance.
Locaserin is separately undergoing evaluation specifically in obese and overweight patients with type 2 diabetes. Results from the Bloom-DM study are due later this year, Arena says. The firm then aims to file the data as an sNDA.
Arena is focused on the development of oral GPCR-targeting drugs for the treatment of cardiovascular, CNS, inflammatory, and metabolic diseases. Early clinical candidates in the firm’s in house pipeline include APD791, a selective inverse agonist of the serotonin 2A receptor for the treatment of arterial thrombosis and other related conditions. The compound has completed Phase Ia and Ib trials.
APD916 is a histamine H3 inverse agonist in development the treatment of narcolepsy and cataplexy. Phase I trials with this drug were started in March. Arena’s preclinical-stage candidate APD811 is a selective agonist of the prostacyclin receptor for the treatment of pulmonary arterial hypertension.
Arena also has an ongoing clinical-stage collaboration with Ortho-McNeil-Janssen Pharmaceuticals, centered on developing compounds targeting GPR119 for the treatment of type 2 diabetes and other related disorders. Ortho-McNeil-Janssen initiated a Phase I trial with candidate APD597 in 2008.