Ligand, Medicines Co. deal
Ligand disclosed in its 2Q13 earnings that the companies mutually terminated a June 2011 deal that granted The Medicines Co. exclusive, worldwide rights to Captisol-enabled IV clopidogrel ( MDCO-157). Ligand said The Medicines Co. elected not to further develop the product after a pharmacokinetic study of oral clopidogrel and MDCO-157 in healthy volunteers showed a "potential difference in metabolism between the oral and IV routes." Ligand said the results "changed the timing and the outlook" of the program for The Medicines Co. and "as a result it no longer fit within their pipeline." Ligand said there are no further financial obligations between the companies, and The Medicines Co. could not be reached.
The Medicines Co. had been developing IV clopidogrel for acute coronary syndrome (ACS) under section 505(b)(2) of the Food, Drug and Cosmetic Act, which allows sponsors to reference data on safety and efficacy from the scientific literature or from previously approved products. All rights to the compound will return to Ligand, which said on its conference call to discuss its 2Q13 earnings that it will "assess the re-partnering landscape" but plans to maintain a focus for the compound in acute myocardial infarction (see BioCentury, June 13, 2011). ...