VANCOUVER, and CONSHOHOCKEN, PA, April 24 /PRNewswire/ - Neuromed Pharmaceuticals Ltd., a biopharmaceutical company developing next-generation chronic pain drugs, announced today 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.
About Neuromed
Neuromed is a privately held biopharmaceutical company in business to develop safer and more effective pain drugs. We are combining our pharmaceutical expertise in research, development and commercialization to improve existing pain treatments as well as develop new pain medicines. For more information visit www.neuromed.com.
--------------------------------------------- CONCERTA(R), DITROPAN XL(R), OROS(R), and PUSH-PULL(TM) are trademarks of ALZA Corporation; JURNISTA(TM) is a trademark of Janssen-Cilag; PROCARDIA XL(R) is a trademark of Pfizer Inc.; COVERA-HS(R) is a trademark of G.D. Searle & Co.; DILAUDID(R) is a trademark of Abbott Laboratories.
Neuromed cautions you that statements included in this press release that are not a description of historical facts may be forward-looking statements. Forward-looking statements are only predictions based upon current expectations and involve known and unknown risks and uncertainties. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of release of the relevant information, unless explicitly stated otherwise. Actual results, performance or achievement could differ materially from those expressed in, or implied by, Neuromed’s forward-looking statements due to the risks and uncertainties inherent in Neuromed’s business including, without limitation, statements about: the progress and timing of its clinical trials; difficulties or delays in development, testing, obtaining regulatory approval, producing and marketing its products; unexpected adverse side effects or inadequate therapeutic efficacy of its products that could delay or prevent product development or commercialization, or that could result in recalls or product liability claims; the scope and validity of patent protection for its products; competition from other pharmaceutical or biotechnology companies; and its ability to obtain additional financing to support its operations. Neuromed does not assume any obligation to update any forward-looking statements.
CONTACT: Julie Jang, Manager, Communications, Neuromed Pharmaceuticals, Phone: (604) 909-2547, Email: jjang@neuromed.com
Neuromed Technologies Inc.
CONTACT: Julie Jang, Manager, Communications, Neuromed Pharmaceuticals,Phone: (604) 909-2547, Email: jjang@neuromed.com
