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Date: 2015-02-09

Type of information: Nomination

Compound:

Company: Cerenis Therapeutics (France)

Therapeutic area: Cardiovascular diseases

Type agreement:

nomination

Action mechanism:

Disease:

Details:

* On February 9, 2015, Cerenis Therapeutics, the biopharmaceutical HDL company developing CER-001, an engineered human apoA-I-containing pre-β HDL mimetic for the treatment of cardiovascular disease, announced the appointment of a new CMO and new Board Members and the leadership of a Phase II clinical CARAT study of CER-001 in post-Acute Coronary Syndrome (ACS) patients.

- Appointment of a new CMO: Dr. Renee Benghozi is an international clinical specialist in the development of pharmaceutical products for the treatment of cardiovascular and metabolic diseases. She has spent more than fifteen years at F. Hoffmann-La Roche Ltd. where she was recently the International Medical Director. Her past career in clinical medicine and her substantial experience in the pharmaceutical industry with the cardiology patients are also extremely valuable regarding her critical management role in drug development at Cerenis.

- Appointment of a new Board Members: Mr. Christian Chavy and Drs. Michael Davidson and Marc Riviere join the Cerenis Board of Directors as new members. Christian Chavy brings substantial pharma and biotech management experience to the Board. He is currently Chief Executive Officer of Stallergenes. In 2010, Mr. Chavy joined ARES Life Science, an investment fund dedicated to healthcare. Previously, he served as President of Global Operations for Actelion Pharmaceuticals. Prior to joining Actelion, he was Vice President at Serono’s reproductive medicine strategic unit in Geneva and Chairman of Serono’s French subsidiary. He also spent five years at Groupe Rhône Poulenc Rorer as its Chairman in Canada, having previously been Chairman and CEO of Rorer France. Dr. Michael H. Davidson is an internationally recognized expert on atherosclerosis and lipids. He is the founder of Omthera Pharmaceuticals, bought by AstraZeneca in 2013. Dr. Davidson has coordinated more than 1,000 clinical trials in areas of preventive cardiology. He has published more than 250 articles for leading medical journals and has written 3 books on Lipidology. Dr. Davidson has been named one of \"The Best Doctors in America\" by Best Doctors Inc. for the past 10 years and was named Father of the Year by the American Diabetes Association, 2010. He recently served as president of the National Lipid Association, and is a Professor of Medicine at the University of Chicago. Dr. Marc Rivière is General Partner at the Montreal-based TVM Capital Life Science team since 2013. Previously he was Vice-President, Axcan Pharma Inc., in charge of Clinical Development and Medical Affairs. Marc’s expertise encompasses various clinical indications from pre-clinical development to post-marketing surveillance. He is a director of GLWL Inc. and an observer on the Board of Colucid Inc.

- Appointment of the Principal Investigator for the future Phase II clinical CARAT study of CER-001:Dr. Stephen Nicholls has been designated to lead the study as Principle Investigator and Chairman of the Steering Committee for the future Phase II clinical CARAT study of 3mg/kg CER-001 in post-Acute Coronary Syndrome (ACS) patients. In May 2012, Dr. Stephen Nicholls was appointed to lead SAHMRI’s Heart Health Research Theme Team (South Australian Health & Medical Research Institute, Adelaide, Australia). Professor Nicholls is the SAHMRI Deputy Director and Heart Foundation Heart Health Theme Leader, Professor of Cardiology at the University of Adelaide and Consultant Cardiologist, Royal Adelaide Hospital. His research interests span the translational spectrum from the factors influencing the biological activity of HDL through to the development and use of innovative plaque imaging modalities and, ultimately, large-scale clinical trials of anti-atherosclerotic therapies.

In addition to Dr. Stephen Nicholls (Principal Investigator), the following outstanding leaders in the field of atherosclerosis research and IVUS technology will make up the CARAT Steering Committee:

- Dr. John Kastelein, professor of medicine, chairman of the department of vascular medicine, Strategic Chair of Genetics in Cardiovascular Disease at the Academic Medical Center of the University of Amsterdam, Amsterdam, The Netherlands;

- Dr. Béla Merkely, Chairman at Semmelweis University Heart and Vascular Center, Head of the Laboratory of Hemodynamics – Saint George Hospital of the County of Fejér, Budapest, Hungary;

- Dr. Steven Nissen, Chairman of the Robert and Suzanne Tomsich Department of Cardiovascular Medicine at Cleveland Clinic’s Sydell and Arnold Miller Family Heart & Vascular Institute, Cleveland, USA;

- Dr. Kausik Ray, Professor of Cardiovascular Disease Prevention in the Division of Cardiovascular Sciences at St George’s Hospital, University of London, Honorary Consultant Cardiologist at St George’s Hospital NHS Trust, London, United Kingdom;

- Dr. Gregory Schwartz, Professor of Medicine Chief, Cardiology Section, at the Veterans Affairs Medical Center, Denver, USA;

- Dr. Stephen Worthley, Head of the Cardiovascular Research Centre at the University of Adelaide and Helpman Professor of Cardiovascular Medicine, Adelaide, Australia.

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