CombinatoRx has garnered its first drug approval. It’s a milestone for the Cambridge, MA-based drug developer, even if the path the company took to reach this point isn’t the one its founders had mapped out when they launched the company in 2000.
The FDA has approved the pain drug hydromorphone HCL (Exalgo), which is an extended-release tablet taken once a day for people with moderate to severe aches and pains, the company (NASDAQ:[[ticker:CRXX]]) reports today. The firm took on U.S. development of the drug through its December merger with Vancouver-based Neuromed Pharmaceuticals. In other words, the pain tablet is not a product of CombinatoRx’s own drug-discovery system, which uses computers to find novel treatments based on synergistic combinations of other drugs.
The approval has earned CombinatoRx—which still has a Vancouver office—a $40 million milestone payment from the healthcare products giant Covidien (NYSE:[[ticker:COV]]). Covidien, which has its corporate offices in Mansfield, MA, acquired U.S. rights to the pain treatment from Neuromed last year and is handling all marketing of the drug through its Mallinckrodt unit. CombinatoRx will get royalties on drug sales from Covidien, which plans to begin selling the product in the first half of this year.
CombinatoRx’s work on this pain drug is largely over, since Covidien is now responsible for all marketing and post-approval studies of the drug. Also, the ALZA unit of Johnson & Johnson (NYSE:[[ticker:JNJ]]), which licensed U.S. rights to the drug to Neuromed in 2007, is in charge of manufacturing supplies of the product that will be sold by Covidien in the U.S. CombinatoRx’s next closest drug to the market is its combination therapy for arthritis, which is in mid-stage clinical development.
The approval has given CombinatoRx’s stock a shot in the arm. According to Google Finance, the stock was up 45 cents, or 40.5 percent, to $1.56 per share in pre-market trading this morning.
