CONSHOHOCKEN, PA and VANCOUVER, BC, June 17 /PRNewswire/ - Neuromed Pharmaceuticals Ltd. announced today that its subsidiary Neuromed Development Inc., has sold the U.S. rights to its lead investigational drug candidate, Exalgo(TM) (hydromorphone HCl) Extended-Release Tablets (CII), to Covidien's subsidiary Mallinckrodt Inc.
On March 23, 2009, Neuromed announced that Exalgo met the primary endpoint in a pivotal phase III clinical trial. On May 22, 2009, Neuromed submitted a response to an Approvable Letter to the U.S. Food and Drug Administration seeking approval for Exalgo for the management of moderate to severe pain in opioid tolerant patients requiring continuous, around-the-clock opioid analgesia for an extended period of time. On June 12, 2009, the FDA informed Neuromed that the Exalgo submission would be classified as a Complete, Class 2 Response with a corresponding PDUFA date of November 22, 2009.
"We believe that Exalgo, designed to be a once-daily hydromorphone formulation, if approved, will offer an additional option in the management of moderate to severe pain in opioid tolerant patients requiring continuous, around-the-clock opioid analgesia for an extended period of time," said Dr. Christopher Gallen, President and Chief Executive Office of Neuromed. "The sale of the Exalgo U.S. rights to Mallinckrodt ensures that Exalgo will be optimally supported going forward."
Neuromed has received a one-time upfront payment. In addition, Neuromed could receive additional development and, if Exalgo is approved, regulatory approval milestone payments, as well as a royalty based on commercial sales of Exalgo.
"The proceeds of the sale of the U.S. rights to Exalgo provides the resources to focus on our corporate strategy of advancing our other key assets and realizing our goal of creating innovative medicines," said Dr. Christopher Gallen, President and Chief Executive Officer of Neuromed. "This strategic move raises significant capital in a manner that supports moving our science forward during a challenging period for our entire industry."
About Exalgo
Neuromed acquired from ALZA Corporation the U.S. rights to Exalgo, an extended release formulation of hydromorphone. Hydromorphone is a Schedule II opioid that has been used for many years. Exalgo is an investigational drug and has not been approved by the FDA. Oral hydromorphone products currently available in the U.S. are immediate release formulations, requiring dosing several times per day. Exalgo employs the OROS(R) PUSH-PULL(TM) osmotic delivery system designed to release hydromorphone at a controlled rate over an extended period of time. An identical formulation, under the trade name JURNISTA(R), has been launched in several countries by Janssen-Cilag. JURNISTA(R) was first launched in Germany in August 2006.
To date, Exalgo has been studied in more than 2,000 patients in clinical trials. The most common adverse events seen in those clinical trials to date are opioid-related events such as constipation, nausea, somnolence, headache, vomiting and dizziness. Respiratory depression is the most important hazard of opioid preparations including Exalgo.
About Neuromed
Neuromed is a privately held biopharmaceutical company in business to develop new and improved pain medicines. Neuromed has three programs aimed at addressing this important unmet medical need. Its lead investigational drug candidate, Exalgo is an extended release formulation of hydromorphone. Neuromed is also developing oral drug candidates to block N-type calcium channels, a new and important target directly involved in pain signaling. Its third program is focused on producing promising T-type calcium channel blockers aimed at treating pain, epilepsy and hypertension. For more information visit our website at www.neuromed.com.
OROS(R) and Push-Pull(TM) are trademarks of ALZA Corporation.
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: regarding this press release, contact: Rachael Froese Zamperini,
Tel: (604) 612-6345, Email: info@outsidein.ca