PARIS, April 19, 2012 /PRNewswire/ -- Sanofi (EURONEXT: SAN andNYSE: SNY) announced today that it has entered into a collaboration with the Michael J. Fox Foundation (MJFF) to conduct a clinical trial to assess the safety and tolerability of AVE 8112, a Sanofi PDE4 inhibitor – phosphodiesterase type 4 inhibitor - in patients with Parkinson's disease (PD).
"AVE8112 has shown promising pro-cognitive activity in preclinical models that could be of interest to the under-addressed cognitive aspects of Parkinson's disease, an area of unmet need where a new treatment could make a tangible difference in patients' lives," said Todd Sherer, Ph.D., Chief Executive Officer of MJFF. "Groundbreaking collaborations with like-minded partners such as Sanofi are a hallmark of the Fox Foundation's approach and help us speed scientific advances with potential to improve the treatment of Parkinson's for patients today and in the future."
Under the terms of the collaboration, MJFF will sponsor a phase I b clinical trial to assess the safety and tolerability of AVE8112 in patients with Parkinson's disease. All data and results generated by the clinical trial will be owned by MJFF and shared with Sanofi. Further development plans will be based upon the results of the study.
"The Michael J. Fox Foundation has been a driving force in discovering and developing improved therapies for those living with Parkinson's disease. Through this research collaboration, together we will be able to study Sanofi's pharmaceutical compound for a possible new treatment for PD patients around the world," said Dr. Elias Zerhouni, President, Global R&D, Sanofi. "We hope to continue to develop relationships with private foundations like the Michael J. Fox Foundation to pool our resources and maximize the potential of our drug portfolio to address unmet medical needs."
The clinical trial will be conducted at clinical sites in the United States in Baltimore, MD, and Los Angeles, CA. Patient enrollment in the study is expected to begin later this year.
About Parkinson's Disease
Over one million people in the US and an estimated 5 million people globally suffer from Parkinson's disease, a neurodegenerative disorder caused by the diminished production of dopamine, a key neurotransmitter, resulting in progressive impairment of motor function including tremors, rigidity and difficulty in moving. Another symptom of PD is cognitive dysfunction, such as difficulty planning, sequencing, initiating and sustaining behavior toward a goal. Estimates vary but some studies suggest a cognitive deficit may occur in up to 80% of people with Parkinson's. While there is a drug approved for the treatment of dementia in PD, there are currently no treatments available for patients who experience less severe cognitive impairments.
Sanofi, a global and diversified healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and the new Genzyme. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
About The Michael J. Fox Foundation for Parkinson's Research
As the world's largest private funder of Parkinson's research, The Michael J. Fox Foundation is dedicated to accelerating a cure for Parkinson's disease and improved therapies for those living with the condition today. The Foundation pursues its goals through an aggressively funded, highly targeted research program coupled with active global engagement of scientists, Parkinson's patients, business leaders, clinical trial participants, donors and volunteers. In addition to funding more than $285 million in research to date, the Foundation has fundamentally altered the trajectory of progress toward a cure. Operating at the hub of worldwide Parkinson's research, the Foundation forges groundbreaking collaborations with industry leaders, academic scientists and government research funders; increases the flow of participants into Parkinson's disease clinical trials with its online tool, Fox Trial Finder; promotes Parkinson's awareness through high-profile advocacy, events and outreach; and coordinates the grassroots involvement of thousands of Team Fox members around the world. Now through December 31, 2012, all new and increased giving to The Michael J. Fox Foundation, as well as gifts from donors who have not given since 2009 or earlier, will be matched on a dollar-for-dollar basis with the $50-million Brin Wojcicki Challenge, launched by Sergey Brin and Anne Wojcicki.
Forward Looking Statements
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words "expects", "anticipates", "believes", "intends", "estimates", "plans" and similar expressions. Although Sanofi's management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the absence of guarantee that the product candidates if approved will be commercially successful, the future approval and commercial success of therapeutic alternatives, the Group's ability to benefit from external growth opportunities, trends in exchange rates and prevailing interest rates, the impact of cost containment policies and subsequent changes thereto, the average number of shares outstanding as well as those discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in Sanofi's annual report on Form 20-F for the year ended December 31, 2011. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.