ARCA biopharma, Inc. (Nasdaq: ABIO), a biopharmaceutical company developing genetically-targeted therapies for heart failure and other cardiovascular diseases, today announced that the European Patent Office has issued a patent on methods of treating heart failure patients with bucindolol based on genetic targeting. The patent (European Patent Number 1802775) entitled “Methods for Treatment with Bucindolol Based on Genetic Targeting,” provides protection for this novel approach to treating patients with heart failure in France, Germany, Netherlands, Switzerland/Liechtenstein, Great Britain, Ireland, Luxembourg, Monaco, Spain, Italy and Sweden. ARCA had previously announced receipt of the European Patent Office Communication under Rule 71(3) EPC notice of intent to grant a European patent for this patent application.
Heart failure is one of the largest health care problems in the world. Industry sources estimate that approximately 14 million people in Europe currently suffer from heart failure and this number is forecast to increase to 30 million by the year 2020.
Over 3.6 million new cases of heart failure are reported each year in Europe.
“We are obviously pleased with the European Patent Office’s issuance of this patent, which we believe will extend our pharmacogenetic intellectual property protection around bucindolol and, if approved for marketing, provide Gencaro market exclusivity in the designated countries into 2025,” said Michael R. Bristow, President and Chief Executive Officer of ARCA.
(bucindolol hydrochloride) is a pharmacologically unique beta-blocker and mild vasodilator being developed for the treatment of chronic heart failure (HF). Gencaro is an oral tablet formulation, dosed twice daily. Gencaro is considered part of the beta-blocker class because of its property of blocking beta-1 as well as beta-2 receptors in the heart, preventing these receptors from binding with other molecules that would otherwise activate the receptor. Because of its mild vasodilator effects, the Company believes Gencaro is well-tolerated in patients with advanced HF.
On May 17, 2010, ARCA announced that it reached agreement with the U.S. Food and Drug Administration (FDA) regarding a Special Protocol Assessment (SPA) on the design of a clinical trial to assess the safety and efficacy of bucindolol in approximately 3,200 patients with chronic heart failure who have the genotype that appears to respond most favorably to bucindolol. An SPA is an agreement with the FDA that the proposed trial protocol design, clinical endpoints and statistical analyses are acceptable to support regulatory approval. The FDA has previously designated as a Fast Track development program the investigation of Gencaro for the reduction of cardiovascular mortality and cardiovascular hospitalizations in a genotype-defined heart failure population. In March 2010, ARCA was awarded a patent from the U.S. Patent and Trademark Office on methods of treating heart failure patients with bucindolol based on genetic testing.