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ARCA Discovery Inc. Names Dr. Ann Lenich Hards Executive Vice President Regulatory Affairs



7/10/2006 10:51:31 AM

DENVER, July 10 /PRNewswire/ -- ARCA Discovery, Inc., a privately held biopharmaceutical company developing genetically-targeted therapies for heart failure and other cardiovascular diseases, today announced the appointment of Ann Lenich Hards, Ph.D., as Executive Vice President Regulatory Affairs. Dr. Hards has over fifteen years of experience in the pharmaceutical/biotechnology industry at Sanofi-Aventis, Somatix Therapy Corporation, Pharmacia Inc. and Parke-Davis Pharmaceuticals, with thirteen years of that experience in regulatory affairs. Most recently, she served as Vice President, Clinical Investigation Realization at Sanofi-Aventis with responsibility for ensuring that clinical development strategies and documentation addressed the current and future standards of regulatory approval. Prior to that, she held a number of senior regulatory-management positions including Vice President Worldwide Cardiovascular and Thrombosis Regulatory Affairs. Notably, Dr. Hards has played an integral part in the preparation, submission and prosecution of eleven new NDAs/major efficacy supplements, including the initial and subsequent approvals of Plavix(R), an anti-platelet agent with a $6.5 billion market. Dr. Hards received her B.S. degree from Purdue University and Ph.D. degree in Biophysics and Genetics from the University of Colorado Health Sciences Center.

In making the announcement, ARCA's President and Chief Executive Officer Dr. Michael R. Bristow said, "We are very pleased to have Ann join the ARCA team. She brings to the Company the regulatory expertise, experienced leadership and knowledge in pharmacogenetics that we need to compile and submit our bucindolol NDA. In addition, the high quality regulatory group that Dr. Hards has assembled at ARCA will play a major role in ARCA's mission to pioneer the development of genetically targeted cardiovascular therapy."

"The future of medicines based on patient genotype has been under discussion for a number of years with limited effects on marketing authorization. It is exciting to be a part of the bucindolol story which has the potential to change this situation and advance the era of genetically customized medicines," said Dr. Hards.

About ARCA Discovery, Inc.

ARCA Discovery, Inc. is a privately held biopharmaceutical company developing genetically-targeted therapies for heart failure and other cardiovascular diseases. The Company's first product is bucindolol, a third generation beta-blocker-vasodilator for advanced heart failure and other indications, that promises to be the first genetically-targeted cardiovascular drug. Bucindolol has extensive Phase III data and a unique Phase III DNA sub-study. Using this sub study, ARCA's founding scientists have confirmed two genetic polymorphisms that interact with bucindolol's unique pharmacology to modify patient response. ARCA is preparing an NDA for bucindolol and intends to seek FDA approval of bucindolol during 2007.

ARCA Discovery, Inc.

CONTACT: Dr. Michael Bristow, President and Chief Executive Officer ofARCA Discovery, Inc., +1-303-893-1599


Read at BioSpace.com


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