On the Radar…

ARCA biopharma announced that it received a complete response letter from the FDA regarding the New Drug Application (NDA) for the use of Gencaro in the treatment of patients with chronic heart failure. The FDA stated it cannot approve Gencaro based on the current application and requested several additional pieces of data. Among the additions requested were an additional clinical efficacy trial, additional clinical pharmacology studies, and additional non-clinical studies to further characterize the metabolites of Gencaro. The FDA response raised concerns about the integrity of the data from the pivotal BEST trial of Gencaro noting questions about specific clinical sites where the trial was conducted. The FDA’s response was made without evaluation of the additional data including comparative effectiveness analysis of Gencaro relative to other β-blocker therapies, clinical pharmacology studies, and some non-clinical data submitted by ARCA in May 2009. ARCA believes that this submission may address several of the key deficiencies cited by the FDA. Investors seem somewhat more skeptical as the company’s stock (NASDAQ: ABIO) is down over 40% in trading this morning. Gencaro (bucindolol hydrochloride), the lead product candidate for ARCA, is a beta-blocker for which ARCA has identified a genetic variation which it believes can help predict individual response to the drug. Based in Broomfield, Colorado, ARCA is focused on the development and commercialization of genetically targeted therapies for cardiovascular conditions.