Alza licensed its Phase III pain drug candidate to Neuromed Pharmaceuticals. The company thus obtained the exclusive U.S. rights to develop and commercialize Oros® Hydromorphone, an extended-release formulation of a potent opioid analgesic.
“Hydromorphone is an effective and well-known pain reliever,” comments Christopher Gallen, M.D., Ph.D., president & CEO of Neuromed, “and we believe a once-daily version can provide a significant benefit for the large number of patients with moderate-to-severe pain that require pain relief around the clock.”
Alza will receive $30 million upfront, additional regulatory milestone fees, and royalties based on commercial sales of the product. Neuromed will develop and market the product in the U.S., while Alza retains the rights in other countries. Alza will manufacture the product for Neuromed as well as for other markets in which the product is sold.
Oros Hydromorphone is already approved in Germany and other European countries and is marketed by Janssen-Cilag under the name JURNISTA™, according to NeuroMed. The company anticipates that one successful clinical trial will be needed to support approval of Oros Hydromorphone in the U.S.
“Oros Hydromorphone is a perfect fit with our existing programs, including our partnered N-type calcium channel program and our own T-type calcium channel blocker program,” Dr. Gallen adds. “Neuromed will develop a specialized sales force to market Oros Hydromorphone in the U.S. upon FDA approval.”
Hydromorphone is a Schedule II opioid that has been widely used for many years under the brand name Dilaudid® and is also available from various generic manufacturers. Current formulations of hydromorphone marketed in the U.S. are immediate release, requiring dosing several times per day.