CARDIOME TRIES AGAIN FOR FDA APPROVAL

Cardiome Pharma is making another attempt at FDA approval for its investigational cardiovascular drug, the company announced.

Cardiome recently met with the agency to discuss problems with its new drug application (NDA), the company said in a July 7 release. The agency sent a "refusal to file" letter to the company in May for RSD1235 (iv), citing "inconsistencies and omissions in the databases submitted with the NDA." The drug is designed for acute conversion of atrial fibrillation.

Cardiome is planning to work with its co-development partner, Astellas Pharma U.S., to address this problem. "Astellas and Cardiome have dedicated substantial resources within their clinical and regulatory groups to conducting a comprehensive re-review and audit of the NDA documents and associated databases," the company said. Cardiome will resubmit its NDA once this review is complete.

Astellas will take on the full financial burden for the resubmission, Cardiome added July 10. Astellas is also modifying the timing of a $10 million payment to Cardiome, bolstering the cash-poor company's finances. Cardiome reported having approximately $8.4 million on hand as of Dec. 31, 2005.

Originally the $10 million was supposed to be paid when the agency accepted the NDA for review. Now the payment will be made once the application is resubmitted.