PDUFA date for Exalgo is approaching (NASDAQ:CRXX)

CombinatoRx, Incorporated (NASDAQ:CRXX) and Neuromed Pharmaceuticals Inc., two companies which have merged into one on June 30, 2009, have developed a drug called Exalgo™ (the brand name for hydromorphone HCl). The companies submitted a new drug application (NDA) to the Food and Drug Administration (FDA) to get the regulator’s approval to market extended release tablets of Exalgo™. Previously, the FDA had accepted the NDA and assigned it a Prescription Drug User Fee Act date – also called Action date or just PDUFA date. However, on November 20, 2009, the companies disclosed to its stockholders that the FDA has delayed the PDUFA date – by 3 months (or 90 days). The new PDUFA date was February 22, 2010. This was the date on which the FDA was supposed to complete reviewing the new drug application and provide its response or feedback to CombinatoRx and Neuromed – specifically, telling the companies whether it has accepted their NDA or not. As a result, all the stakeholders of CombinatoRx and Neuromed were eagerly waiting for this day. However, they would have to wait for longer since the PDUFA date got extended again – though, only by a week. The expected PDUFA date is March 1, 2010.

So, why did the FDA extend the PDUFA date in the first instance? The answer was given by CombinatoRx. According to the company, the FDA wanted “more time” to conduct a thorough review of the new drug application. The companies also made a few changes to its submitted NDA. The FDA also needed time to review these changes.

As expected, the FDA review was completed before February 22 (the prior expected PDUFA date); however, the regulator could not announce its decision because of “government closings” that happened due to unfavorable weather conditions.

In the meantime, both companies are working closely with Mallinckrodt Inc., a company of Coviden (NYSE: COV) which will be commercializing Exalgo in the markets of United States – if the NDA is accepted by the Food and Drug Administration. For this agreement, Neoromed, which is a privately owned specialty biopharmaceutical company, was given “milestone payments” of more than $15 million. Neuromed will receive a higher payment – higher than $30 million – if the FDA approved the NDA. Mallinckrodt will also pay (about $16 million) for the expenses of clinical development and other activities needed for regulation of Exalgo.