Neuromed Pharmaceuticals Ltd announced that its subsidiary Neuromed Development Inc, has sold the US rights to its lead investigational drug candidate, Exalgo (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 US 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 US 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 US 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."
Exalgo is an investigational drug and has not been approved by the FDA. Oral hydromorphone products currently available in the US are immediate release formulations, requiring dosing several times per day.
Neuromed is a privately held biopharmaceutical company in business to develop new and improved pain medicines. Neuromed has three programmes aimed at addressing this important unmet medical need.