Cardiome: Astellas to fund new NDA filing for RSD1235

By Elaine Rigoli

Tampa, Fla., July 10 - Cardiome Pharma Corp. said Astellas Pharma US, Inc. has agreed to fund 100% of the costs associated with the planned re-submission of the New Drug Application for RSD1235, an investigational new drug for acute conversion of atrial fibrillation.

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.

In October 2003, Cardiome granted Astellas' predecessor Fujisawa Healthcare, Inc. 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, the United States and Mexico and has also retained worldwide rights to oral RSD1235.

Cardiome is a product-focused cardiovascular drug-development company based in Vancouver, B.C.

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