BioCentury
ARTICLE | Clinical News

Exalgo regulatory update

March 8, 2010 8:00 AM UTC

FDA approved an NDA for Exalgo hydromorphone to manage moderate to severe pain in opioid-tolerant patients. The approval triggers a $40 million milestone payment from U.S. commercialization partner Covidien to CombinatoRx, which merged with Neuromed Pharmaceuticals Ltd. late last year. Under the terms of the merger, former Neuromed shareholders received 37,883,123 in Escrow shares upon approval of Exalgo, increasing their stake in the combined company to about 60%. CombinatoRx is also eligible for tiered royalties on sales of the extended-release formulation of hydromorphone hydrochloride. ...