VANCOUVER and DEERFIELD, IL, Jan. 21 /PRNewswire-FirstCall/ - CardiomePharma Corp. (NASDAQ: CRME / TSX: COM) and its co-development partner AstellasPharma US, Inc. ("Astellas") today announced that they have been informed bythe U.S. Food and Drug Administration (FDA) that a decision has not yet beenmade regarding the New Drug Application (NDA) for KYNAPID(TM) (vernakalanthydrochloride). The FDA did not provide an action letter prior to the PDUFAdate of January 19, 2008.
"While we look forward to the FDA reaching a decision, we respect theirneed for additional time to review the KYNAPID NDA," said William E.Fitzsimmons, PharmD, Senior Vice President, Research & Development atAstellas. "Astellas and Cardiome strongly believe in the therapeutic value ofKYNAPID based on clinical trial data and are confident it will be an importanttherapy in the treatment of atrial fibrillation."
In October 2003, Cardiome granted Astellas Pharma US, Inc. an exclusivelicense to develop and commercialize KYNAPID in North America. Cardiome hasretained all rights to the intravenous formulations outside of Canada, theU.S. and Mexico. The NDA for KYNAPID, based on a five-year clinicaldevelopment program, was submitted in December 2006. In December 2007, the FDACardiovascular and Renal Drugs Advisory Committee voted 6-2 in favour ofrecommending to the FDA that KYNAPID be approved for the rapid conversion ofacute AF to sinus rhythm.
Cardiome Pharma Corp. is a product-focused cardiovascular drug developmentcompany with two late-stage clinical drug programs focused on atrialarrhythmia (intravenous and oral dosing), a Phase 1 program for GED-aPC, anengineered analog of recombinant human activated Protein C, and a pre-clinicalprogram directed at improving cardiovascular function.
Vernakalant (iv) is the intravenous formulation of an investigational drugbeing evaluated for the acute conversion of atrial fibrillation. Positivetop-line results from two pivotal Phase 3 trials for vernakalant (iv), calledACT 1 and ACT 3, were released in December 2004 and September 2005. Cardiome'sco-development partner Astellas Pharma US, Inc. submitted a New DrugApplication for vernakalant (iv) in December 2006. Positive top-line resultsfrom an additional Phase 3 study evaluating patients with post-operativeatrial arrhythmia, called ACT 2, were released in June 2007. An open-labelsafety study evaluating recent-onset AF patients, called ACT 4, has completed.
Vernakalant (oral) is being investigated as a chronic-use oral drug forthe maintenance of normal heart rhythm following termination of AF. Cardiomeannounced positive results from a Phase 2a pilot study for vernakalant (oral)in September 2006. A Phase 2b study for vernakalant (oral) is ongoing.
In April 2007 Cardiome acquired exclusive worldwide rights for GED-aPC forall indications. Cardiome intends to initially develop GED-aPC in cardiogenicshock, a life-threatening form of acute circulatory failure due to cardiacdysfunction, which is a leading cause of death for patients hospitalizedfollowing a heart attack.
Cardiome is traded on the Toronto Stock Exchange (COM) and the NASDAQNational Market (CRME).
Astellas Pharma US, Inc., located in Deerfield, Illinois, is a U.S.affiliate of Tokyo-based Astellas Pharma Inc. Astellas is a pharmaceuticalcompany dedicated to improving the health of people around the world throughthe provision of innovative and reliable pharmaceutical products. Theorganization is committed to becoming a global category leader in focusedareas by combining outstanding R&D and marketing capabilities.
In the US, Astellas markets products in the areas of Immunology, Urology,Anti-Infectives, Cardiovascular and Dermatology. For more information aboutAstellas Pharma US, Inc., please visit our website at www.astellas.com/us.