ARCA biopharma, Inc. (Nasdaq: ABIO), a biopharmaceutical company
developing genetically targeted therapies for heart failure and other
cardiovascular diseases, today announced that the U.S. Patent and
Trademark Office (USPTO) has issued a patent on methods of treating
heart failure patients with bucindolol based on genetic testing. The
patent (USP# 7,678,824) entitled “Methods for Treatment with Bucindolol
Based on Genetic Targeting,” provides protection in the United States
for this novel approach to treating patients with heart failure, one of
the largest health care problems in the United States and the rest of
the world. ARCA had previously announced the notice of allowance of this
patent. Industry sources estimate that approximately 5.7 million
Americans have heart failure and nearly 670,000 new patients are
diagnosed annually. In addition, heart failure is the underlying reason
for approximately 12 to 15 million annual visits to physicians,
6.5 million annual hospital days and over $37 billion in direct and
indirect healthcare costs in the United States.
“Methods for Treatment with Bucindolol Based on
Genetic Targeting”
“We are obviously pleased with the USPTO’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 into 2025,” said Michael R. Bristow,
President and Chief Executive Officer of ARCA. “Chronic heart failure
continues to be a major health care problem, and among the challenges to
improving care is the uncertainty of patient responses to drug
treatment. We believe that a new heart failure therapy that includes a
simple test to identify a substantial subpopulation of patients more
likely to benefit has the potential to help alleviate some of the
problems encountered with the current standard of practice.”
On March 25, 2010, ARCA submitted a revised clinical study protocol for
review under the U.S. Food and Drug Administration’s (FDA) Special
Protocol Assessment (SPA) process for the design of a clinical trial to
assess the safety and efficacy of Gencaro in approximately 3,200
patients with chronic heart failure who have the genotype that appears
to respond most favorably to Gencaro. 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. Any
proposed trial protocol must be reviewed and agreed upon with the FDA
and the final trial protocol may be significantly different from the
Company’s SPA submission. If ARCA obtains sufficient funding and FDA
approval of the SPA, ARCA currently expects it could begin the proposed
clinical trial approximately one year after such funding and 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.
Study: 40% of newly diagnosed heart failure patients also have atrial fibrillation