Cardiome cardiovascular news
Cardiome said it will seek external funding and/or partners for its GED-aPC program. The engineered analog of recombinant human activated protein C (APC) is in Phase I testing to treat cardiogenic shock, with data expected by year end. Cardiome said the move would allow it to share financial risk and to give the program the maximum chance of success. As a result of the decision, CMO and EVP of Clinical Regulatory Affairs Charles Fisher will leave the company but assist as a consultant in developing the program. The company received exclusive worldwide rights to the compound from Eli Lilly and Co. (NYSE:LLY, Indianapolis, Ind.) in 2007 (see BioCentury, May 7, 2007).
Cardiome's IV vernakalant is under EMEA review to treat acute atrial fibrillation (AF). Merck & Co. Inc. (NYSE:MRK, Whitehouse Station, N.J.) has exclusive rights from Cardiome to develop and commercialize the IV formulation of the mixed ion channel antagonist outside the U.S., Canada and Mexico, where Astellas Pharma Inc. (Tokyo:4503, Tokyo, Japan) has rights, and worldwide rights to the oral formulation under a 2009 deal with Cardiome. The biotech received an approvable letter from FDA for the IV formulation in 2008, while the oral formulation of the mixed ion channel antagonist is in Phase II testing (see BioCentury, Aug. 17). ...