Sanofi To Expand Access to Clinical Trial Data
Paris, France – January 2, 2014 – Starting in January, Sanofi (EURONEXT: SAN and NYSE: SNY) will expand access to information and data from clinical trials, sponsored by companies of the Sanofi group, in support of industry-wide efforts to promote a set of Principles for Responsible Sharing of Clinical Trial Data that the Pharmaceutical Research and Manufacturers of America (PhRMA) and the European Federation of Pharmaceutical Industries and Associations (EFPIA) jointly released in July 2013.
“Sanofi has a history of contributing in this collective effort of sharing clinical trial data and results with researchers and patients with initiatives such as Project Data Sphere, an independent initiative of the Life Sciences Consortium of the CEO Roundtable on Cancer, the Coalition Against Major Diseases, and Prize4Life”, said Christopher A. Viehbacher, Sanofi Chief Executive Officer and currently serving as President of EFPIA. “Finding new therapies can be accelerated by fully sharing the successful and unsuccessful research results with other researchers. Data sharing helps to reduce duplication and allows researchers to build more effectively on the findings of other researchers. The private sector has taken a lead on this which I would hope academic researchers will follow.”
Sanofi will provide access to clinical trial data and related documents, including Clinical Study Reports (CSR), for studies sponsored by Sanofi companies that conduct clinical studies in humans. These studies must have been submitted to U.S. and E.U. regulatory agencies and the product must have been approved by both agencies on or after January 1, 2014. For Sanofi Pasteur, requested studies must have been submitted either to the U.S. or E.U. regulatory agencies and the product must have been approved by either agency on or after January 1, 2014.
Sanofi will continue to submit for publication the results from all company-sponsored clinical studies, regardless of the study outcome. In addition, the industry, including Sanofi, is working with regulators to adopt mechanisms so that clinical study sponsors will be able to provide lay language summary results directly to the individuals who participate.
To enable the process for requesting and gaining access to clinical trial data, Sanofi is participating in a multi-company portal for clinical trial data sharing (https://clinicalstudydatarequest.com). A link to this portal is available on the Sanofi.com website as of January 1.
For further information see: Our Data Sharing Commitments
Sanofi, an integrated global 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).
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, 2012. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.
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