Covidien plc (COV) announced that the U.S. Food and Drug Administration has approved the New Drug Application 21-217 for Exalgo, or hydromorphone Hcl, Extended-Release Tablets, or CII. The indication for Exalgo is once daily administration 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. Covidien expects that it will launch Exalgo tablets in the first half of calendar year 2010.
In addition, CombinatoRx Inc. (CRXX) said that it 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, about 38.61 million 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 88.61 million.
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