Cardiome and Astellas have revised their development pact on RSD 1235, an experimental therapy for atrial fibrillation, the most common form of arrhythmia. The FDA had rejected their application for the drug last spring, citing inconsistencies and omissions in the data they provided. Developers blamed a clerical error. In the new agreement, Astellas will pay Cardiome $10 million when it files with the agency and will cover all the costs of revising the application. In their original agreement, Cardiome was to receive $10 million only if the FDA accepted the application for review. Cardiome CEO Bob Rieder called the new agreement an indication of Astellas' confidence in the therapy. Analysts have been waiting for upcoming data on a mid-stage clinical trial of an oral formulation of RSD 1235.
- here's the article on the deal from the Globe and Mail