FDA Approves Exalgo™ Extended-Release Tablets

Main Category: Pain / Anesthetics
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 04 Mar 2010 - 3:00 PDT

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CombinatoRx, Incorporated (NASDAQ: CRXX) announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for Exalgo™ (hydromorphone HCl) extended-release tablets, 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.

CombinatoRx will receive a $40 million milestone payment from Covidien based on Exalgo approval and is eligible to receive tiered royalties on Exalgo net sales. Under the terms of the agreements relating to the merger with Neuromed Pharmaceuticals, effective with the FDA approval of Exalgo, approximately 38,609,168 additional shares of CombinatoRx common stock are outstanding, resulting in CombinatoRx having total shares of common stock outstanding following FDA approval of Exalgo of approximately 88,610,640.

"Our considerable product development expertise played a key role in facilitating this successful NDA submission, with the goal of providing much needed relief to those who suffer from chronic pain," commented Mark H.N. Corrigan, MD, President and CEO of CombinatoRx. "We will continue to apply our strong development capabilities to the many promising drug candidates in our pipeline going forward."

The U.S. rights to Exalgo tablets were acquired from Neuromed by Mallinckrodt Inc., a Covidien company, in June, 2009. Neuromed acquired the U.S. marketing rights to Exalgo tablets from ALZA Corporation in April 2007 and was responsible for clinical development and regulatory filings. Covidien is responsible for all commercialization activities for Exalgo in the U.S., including marketing, sales and all post-approval FDA regulatory filings, and will now own the intellectual property for the product. ALZA is responsible for manufacturing, packaging and supply of the product. CombinatoRx and Neuromed merged on December 21, 2009.

Source
CombinatoRx

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