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news.Cardiome Pharma and Astellas are to amend their co-development agreement in order to aid the resubmission of RSD1235 for the treatment of atrial fibrillation after the FDA refused to file the initial application for the drug.
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As a result of a recent meeting with the FDA, the companies announced that they would re-submit an amended application seeking approval for RSD1235.
Under terms of the amended agreement, Astellas has agreed to fund 100% of the costs associated with re-submission 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 re-submission. Prior to this amendment, the milestone was conditional on acceptance of the NDA for review.
“This action by our partner Astellas is a clear demonstration of their confidence in the RSD1235 program,” said Bob Rieder, CEO of Cardiome. “The integrity and commitment embodied in this Astellas action demonstrates again that they are an outstanding partner company.”
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, US and Mexico, and has also retained worldwide rights to oral RSD1235 for the prevention of atrial fibrillation.