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Biotech / Medical : Cardiome -- CRME
CRME 2.330-2.1%May 16 5:00 PM EST

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From: tuck8/11/2008 9:55:50 AM
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>>Cardiome And Astellas Announce Receipt Of FDA Approvable Letter For KYNAPID(TM)
Monday August 11, 9:18 am ET
NASDAQ: CRME TSX: COM

VANCOUVER and DEERFIELD, IL, Aug. 11 /PRNewswire-FirstCall/ - Cardiome Pharma Corp. (NASDAQ: CRME/TSX: COM) and its co-development partner Astellas Pharma US, Inc. ("Astellas") today announced that they have received an action letter dated August 8, 2008 from the U.S. Food and Drug Administration (FDA) for KYNAPID(TM) (vernakalant hydrochloride) Injection for the treatment of atrial fibrillation (AF) - a potentially life-threatening condition that occurs when electrical signals in the heart malfunction. KYNAPID is under review for the rapid conversion of AF to sinus rhythm.

In the action letter, the FDA informed the sponsor (Astellas) that it has completed its review of the KYNAPID NDA and that the application is approvable. Prior to considering approval, FDA requires additional information associated with the risk of previously identified events experienced by a subset of patients during the clinical trials in order to assure an acceptable risk benefit profile compared to electrical cardioversion. FDA has also requested a safety update from ongoing or completed studies of vernakalant, regardless of indication, dosage form, or dose level. Cardiome and Astellas will work closely with the FDA to address all issues raised in the approvable letter.

"Astellas will be in contact with the FDA within the next few days to discuss next steps, and we expect that several months may be required to assemble a complete and appropriate response," stated Bob Rieder, Chief Executive Officer and Chairman of Cardiome. "While this action letter could result in the need for an additional clinical study, Cardiome is optimistic that the questions raised can be satisfactorily addressed from currently available data."

"Astellas and Cardiome strongly believe in the therapeutic value of KYNAPID based on clinical trial data and are confident it will be an important therapy in the treatment of atrial fibrillation," said William E. Fitzsimmons, PharmD, Senior Vice President, Research & Development at Astellas.

In October 2003, Cardiome granted Astellas Pharma US, Inc. an exclusive license to develop and commercialize KYNAPID in North America. Cardiome retains worldwide rights to vernakalant (oral) for the prevention of AF recurrence and all rights to the intravenous formulations outside of Canada, U.S. and Mexico. The NDA for KYNAPID, based on a five-year clinical development program, was submitted in December 2006.<<

I have vague memories about a safety issue in a subset, but can't find my notes on this. I seem to remember a cardiologist consultant on a conference call, saying he didn't think it would be a deal breaker. Oh, well.

Stock getting beaten back down into the $7s on this.

Cheers, Tuck
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