CombinatoRx will be forced to wait at least until March 1 to hear if the FDA will approve its new pain drug Exalgo as regulators scramble to make up for the time lost to back-to-back blizzards.
The FDA's original PDUFA date was November 22, 2009 and missing that deadline proved financially painful for a big group of CombinatoRx shareholders. The developer was forced to restructure after its lead therapy flunked a mid-stage trial, and that set the stage for a complicated merger with Neuromed, which had advanced Exalgo through the trial process. Under the merger deal, CombinatoRx shareholders would have owned 30 percent of the combined company if Exalgo had been approved by January 1. Missing that deadline pushed their share to 40 percent of the company.
This delay, though, shouldn't be quite so costly to the pre-merger Neuromed shareholders. Pre-merger CombinatoRx shareholders will only see their equity jump another 20 percent if there's no approval by September 30. And it jumps another 10 percent if there's no approval by the end of the year.
A subsidiary of Covidien acquired the U.S. rights to the drug ahead of the merger. Exalgo is a once-daily form of hydromorphone commonly known by its brand name Dilaudid. FDA staffers have expressed some concerns about its potential abuse.
- check out the CombinatoRx's release