The Medicines Co. abandons blood-loss drug over safety risk
The Medicines Company has ditched development of an experimental drug to lessen loss of blood in surgeries after spotting patient safety problems in a Phase IIb study, the company revealed on Thursday. The company was mum about the specific safety issues, saying that it would investigate and then publish them down the road.
The Parsippany, NJ-based company ($MDCO), which specializes in critical care treatments, says that the mid-stage study of the serine protease inhibitor known as MDCO-2010 was stopped after recruiting 44 of a planned 90 subjects for the initial stage of the trial. It alerted health authorities in Germany and Switzerland, where patients had been enrolled, along with Health Canada and the FDA because of plans to conduct the study in Canada and the U.S.
The setback deals an obvious blow the company's pipeline, which features three drugs in late-stage development and one earlier-stage product now that the firm has ended development of MDCO-2010. Those late-stage contenders include the anti-platelet treatments cangrelor and MDCO-157 as well as the broad-spectrum antibiotic oritavancin. The Medicines Company acquired oritavancin in its buyout of Targanta Therapeutics announced in 2009 after the FDA denied approval of the antibiotic.