Pharmacogenetic Patents Have the Potential to Extend Drug Candidate’s Potential Commercial Exclusivity Period If Regulatory Approval Obtained

ARCA biopharma, Inc., a biopharmaceutical company developing genetically targeted therapies for cardiovascular diseases, announced that the U.S. Patent and Trademark Office (USPTO) has issued a patent on methods for determining whether to administer or prescribe bucindolol to a patient based on whether the patient has a specific genotype – homozygous for the arginine 389 polymorphism in the beta-1 adrenergic receptor. The patent (USP# 8,093,286) entitled “Methods for Treatment with Bucindolol Based on Genetic Targeting,” provides intellectual property protection in the United States for this novel approach to treating patients with bucindolol.

“We are pleased with the USPTO’s issuance of this patent, which we believe extends our pharmacogenetic intellectual property protection around bucindolol,” said Michael R. Bristow, President and Chief Executive Officer of ARCA. “This patent provides protection for the means to identify patients with a specific genotype, which, based on data from a prior Phase 3 clinical trial, we believe has more favorable cardiovascular responses to Gencaro as compared to the general population of patients with all genotypes. In a planned phase 3 clinical trial, we intend to evaluate bucindolol as a potential treatment for the prevention of atrial fibrillation in patients with this genotype, which we estimate is present in approximately 50% of the U.S. general population. We believe an important benefit of a pharmacogenetic approach to drug development is the potential for extending a drug candidate’s potential period of commercial exclusivity, if regulatory approval is obtained.”

About ARCA biopharma
ARCA biopharma is dedicated to developing genetically-targeted therapies for cardiovascular diseases. The company's lead product candidate, Gencaro™ (bucindolol hydrochloride), is an investigational, pharmacologically unique beta-blocker and mild vasodilator being developed for atrial fibrillation. ARCA has identified common genetic variations that it believes predict individual patient response to Gencaro, giving it the potential to be the first genetically-targeted atrial fibrillation prevention treatment. ARCA is collaborating with Laboratory Corporation of America to develop the companion genetic test for Gencaro.