Neuromed licenses chronic pain product from ALZA Corporation

Neuromed Pharmaceuticals has announced that it has licensed from ALZA Corporation the exclusive U.S. rights to develop and commercialize OROS(R) Hydromorphone, an extended release formulation of a potent opioid analgesic in Phase 3 clinical development.

Under the terms of the agreement Neuromed will make an upfront payment of $30 million, additional regulatory milestone payments, and will pay royalties based on commercial sales of the product. Neuromed will develop and market the product in the U.S., while ALZA will retain the rights to develop and market the product in other countries. ALZA will manufacture the product for Neuromed as well as for other markets in which the product is sold.

OROS(R) Hydromorphone was developed by ALZA and uses the OROS(R) PUSH-PULL(TM) delivery system to release the opioid at a controlled rate. OROS(R) Hydromorphone has been approved in Germany and other European countries and is marketed by Janssen-Cilag under the name JURNISTA(TM). The product received an Approvable Letter from the U.S. Food and Drug Administration (FDA) in October, 2000. Neuromed anticipates that one successful adequate and well-controlled clinical trial will be needed to support approval of OROS(R) Hydromorphone in the U.S.

"Our licensing of the U.S. rights to OROS(R) Hydromorphone from ALZA is an excellent fit with Neuromed's strategy to address the significant need for alternative chronic pain treatments," said Dr. Christopher Gallen, President & CEO of Neuromed. "Hydromorphone is an effective and well-known pain reliever 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."

"OROS(R) 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 added. "Neuromed will develop a specialized sales force to market OROS(R) Hydromorphone in the U.S. upon FDA approval. The addition of a commercial presence in the U.S. will allow Neuromed to market niche products while continuing its dedication to the research and discovery of novel, breakthrough analgesics."

Hydromorphone is a Schedule II opioid that has been widely used for many years under the brand name DILAUDID(R) 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.

OROS(R) Hydromorphone employs the OROS(R) osmotic drug delivery technology.

The OROS(R) osmotic drug delivery technology provides controlled drug release over an extended period and has been employed as a sustained release formulation for many successful products, including CONCERTA(R), DITROPAN XL(R), COVERA-HS(R), and PROCARDIA XL(R). Four dosage strengths of OROS(R) Hydromorphone (8 mg, 16 mg, 32 mg and 64 mg) are currently marketed in Europe, with an additional lower strength (4 mg) in development.

OROS(R) Hydromorphone is an investigational product and is not approved by the FDA for use in the U.S. OROS(R) Hydromorphone has been studied in more then 1000 pain patients. The most common adverse events seen in clinical trials to date were opioid-related events of constipation, nausea, somnolence, headache, vomiting and dizziness. Respiratory depression is the most important hazard of opioid preparations including OROS(R) Hydromorphone.

http://www.neuromed.com/