Staff and Wire Reports
Wednesday, 17 February 2010 08:43
While small cap investors had begun to bet big in anticipation of an FDA approval decision for CombinatoRx, Incorporated's (NASDAQ: CRXX) painkiller drug, federal regulators have decided to extend the review after a massive snowstorm in Washington shut down agency offices.
The Food and Drug Administration set a new review date of March 1 for Exalgo.
The U.S. rights to Exalgo tablets were acquired from Neuromed by Mallinckrodt Inc., a Covidien company, in June, 2009.
Neuromed then acquired the U.S. marketing rights to Exalgo tablets from ALZA Corporation in April 2007 and was responsible for clinical development and regulatory filings. CombinatoRx and Neuromed merged on December 21, 2009.
Covidien, which is based in Ireland and whose U.S. headquarters are in St. Louis, 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.
The drug is an extended-release opioid painkiller. It will be interesting to see how shares react to the news which was released one minute after the market closed on Tuesday. Most investors react negatively to delay news, but the announced delay is only one week.
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