Cardiome Pharma has announced amendments to its co-development agreement with Astellas Pharma related to the planned resubmission of the new drug application (NDA) for RSD1235 (iv), an investigational new drug for acute conversion of atrial fibrillation.
Under terms of the amended agreement, Astellas has agreed to fund 100 percent of the costs associated with resubmission of the NDA, including engagement of any external consultants. Astellas has also agreed to modify the timing of the $10 million NDA milestone, which will now be payable on the date of resubmission. Prior to this amendment, the milestone was conditional on acceptance of the NDA for review.
In October 2003, Cardiome granted Astellas' predecessor, Fujisawa Healthcare, an exclusive license to develop and commercialize the intravenous formulation of RSD1235 in North America. Cardiome has retained all rights to the intravenous formulations outside of Canada, U.S. and Mexico, and has also retained worldwide rights to oral RSD1235 for the prevention of atrial fibrillation.