Shionogi and Purdue Pharma establish alliance for joint U.S. commercialization of naldemedine.

Shionogi & Co., Ltd., a drug-discovery based pharmaceutical company and Purdue Pharma L.P., a privately-held pharmaceutical company, announced the establishment of an alliance for the joint U.S. launch and commercialization of Symproic (naldemedine). Symproic, a novel peripherally-acting mu opioid receptor antagonist (Pamora) for the treatment of opioid-induced constipation (OIC) in adults with chronic non-cancer pain, is currently under review at the U.S. Food & Drug Administration (FDA). The target action date for Symproic under the Prescription Drug User Fee Act (PDUFA) is Mar. 23, 2017.

In this alliance, Purdue’s expertise in the care of patients with pain will be combined with Shionogi’s knowledge as the inventor and global developer of naldemedine. Purdue and Shionogi will jointly launch and commercialize Symproic, including a comprehensive collaboration on all aspects of strategy, sales, and other activities.

“Shionogi is very pleased to create this alliance with Purdue, which is well established as the U.S. leader in providing treatments for those burdened with chronic pain. We firmly believe that Purdue is optimally positioned to bring naldemedine to market, following approval by FDA for the treatment of OIC in adult patients with chronic non-cancer pain, to benefit the appropriate patients and to the healthcare providers that care for them,” said Dr. Isao Teshirogi, president and chief executive officer, Shionogi & Co., Ltd.

“This alliance brings us into an exciting new therapeutic area and offers us the opportunity to further help patients with chronic pain while advancing our plans to diversify in high need areas adjacent to pain,” said Mark Timney, president and chief executive officer, Purdue Pharma L.P. “We’ve had a successful, long-term, strategic relationship with Shionogi for two decades and we look forward to continuing our work with them.”

Chadbourne & Parke LLP served as lead outside counsel for Purdue Pharma. Norton Rose Fulbright served as lead outside counsel for Shionogi.

(Source: Business Wire)