CRME off 41% in Toronto [t]tse:com[/t] on FDA delay in IV V response. Has recovered somewhat and is now off about 13%.
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Cardiome And Astellas Announce Regulatory Update
NASDAQ: CRME TSX: COM
VANCOUVER and DEERFIELD, IL, Jan. 21 /PRNewswire-FirstCall/ - Cardiome Pharma Corp. (NASDAQ: CRME / TSX: COM) and its co-development partner Astellas Pharma US, Inc. ("Astellas") today announced that they have been informed by the U.S. Food and Drug Administration (FDA) that a decision has not yet been made regarding the New Drug Application (NDA) for KYNAPID(TM) (vernakalant hydrochloride). The FDA did not provide an action letter prior to the PDUFA date of January 19, 2008.
"While we look forward to the FDA reaching a decision, we respect their need for additional time to review the KYNAPID NDA," said William E. Fitzsimmons, PharmD, Senior Vice President, Research & Development at Astellas. "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."
In October 2003, Cardiome granted Astellas Pharma US, Inc. an exclusive license to develop and commercialize KYNAPID in North America. Cardiome has retained all rights to the intravenous formulations outside of Canada, the U.S. and Mexico. The NDA for KYNAPID, based on a five-year clinical development program, was submitted in December 2006. In December 2007, the FDA Cardiovascular and Renal Drugs Advisory Committee voted 6-2 in favour of recommending to the FDA that KYNAPID be approved for the rapid conversion of acute AF to sinus rhythm.
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