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Sanofi (France) (SAN.PA) And Regeneron Pharmaceuticals, Inc. (REGN)'s Dupilumab Named "Clinical Advance Of The Year" By Scrip Intelligence


11/25/2013 10:02:26 AM

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PARIS
and TARRYTOWN, N.Y., Nov. 25, 2013 /PRNewswire/ -- Sanofi (EURONEXT: SAN and NYSE: SNY) and Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the Phase 2a study of dupilumab in asthma was named "Clinical Advance of the Year" by Scrip Intelligence at the 9th annual Scrip Awards. The award was announced last week by Scrip, a leading pharmaceutical industry publication.

Dupilumab is a fully-human monoclonal antibody that is being developed by Regeneron and Sanofi for the treatment of asthma, atopic dermatitis, and nasal polyposis.

George D. Yancopoulos, M.D., Ph. D., Chief Scientific Officer of Regeneron and President of Regeneron Laboratories, said, "We appreciate the recognition by Scrip that dupilumab is one of the most exciting emerging clinical candidates in the industry. We feel that this award is additional validation of the overall depth and productivity of our R&D team and the powerful VelociSuite® technologies they employ, which have delivered dupilumab and several other investigational therapeutic opportunities."

"On behalf of all of the men and women within our organizations working diligently to develop this investigational treatment, we are truly honored by this award," said Elias Zerhouni, M.D., President Global R&D, Sanofi. "The ultimate recognition for their innovative research, at the end of the day, is when we are able to deliver improved solutions to patients."

Award winners were selected by a 15-member panel of leading pharmaceutical industry executives, consultants, and researchers. More information about the panel is available at: http://www.scripintelligence.com/awards/judges/. In 2012, Scrip honored Regeneron as its Biotech Company of the Year.

About Dupilumab (REGN668/SAR231893)
Dupilumab is a fully human investigational monoclonal antibody delivered by subcutaneous injection that targets the alpha subunit of the interleukin 4 receptor (IL-4R alpha). By blocking IL-4R alpha, dupilumab modulates signaling of both IL-4 and IL-13, drivers of Th2 (Type 2 helper T cell) immune response. Dupilumab was created using Regeneron's VelocImmune® gene modification technologies and is being co-developed with Sanofi. Dupilumab is currently in Phase 2 studies in atopic dermatitis, asthma and nasal polyposis.

About Sanofi
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).

About Regeneron Pharmaceuticals, Inc.
Regeneron is a leading science-based biopharmaceutical company based in Tarrytown, New York that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron markets medicines for eye diseases, colorectal cancer, and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including hypercholesterolemia, oncology, rheumatoid arthritis, asthma, and atopic dermatitis. For additional information about the company, please visit www.regeneron.com.

Sanofi 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, 2012. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.

Regeneron Forward-Looking Statements
This news release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron, and actual events or results may differ materially from these forward-looking statements. Words such as "anticipate," "expect," "intend," "plan," "believe," "seek," "estimate," variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, the nature, timing, and possible success and therapeutic applications of Regeneron's products, product candidates, and research and clinical programs now underway or planned, including without limitation dupilumab; unforeseen safety issues resulting from the administration of products and product candidates in patients, including serious complications or side effects in connection with the use of Regeneron's product candidates in clinical trials; the likelihood and timing of possible regulatory approval and commercial launch of Regeneron's late-stage product candidates; ongoing regulatory obligations and oversight impacting Regeneron's research and clinical programs and business; determinations by regulatory and administrative governmental authorities which may delay or restrict Regeneron's ability to continue to develop or commercialize Regeneron's products and product candidates; competing drugs and product candidates that may be superior to Regeneron's products and product candidates; uncertainty of market acceptance and commercial success of Regeneron's products and product candidates; the ability of Regeneron to manufacture and manage supply chains for multiple products and product candidates; coverage and reimbursement determinations by third-party payers, including Medicare and Medicaid; unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron to meet any of its sales or other financial projections or guidance and changes to the assumptions underlying those projections or guidance; the potential for any license or collaboration agreement, including Regeneron's agreements with Sanofi and Bayer HealthCare, to be cancelled or terminated without any further product success; and risks associated with third party intellectual property and pending or future litigation relating thereto. A more complete description of these and other material risks can be found in Regeneron's filings with the United States Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2012 and its Form 10-Q for the quarterly period ended September 30, 2013. The reader is cautioned not to rely on any forward-looking statements made by Regeneron. Regeneron does not undertake any obligation to update publicly any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise.

Sanofi Contacts:








Media Relations



Investor Relations

Jack Cox



Sebastien Martel

Tel.: + (33) 1 53 77 46 46



Tel.: + (33) 1 53 77 45 45

mr@sanofi.com



ir@sanofi.com





Regeneron Contacts:








Media Relations



Investor Relations

Peter Dworkin



Manisha Narasimhan, Ph.D.

Tel: 1 (914) 847-7640



Tel: 1 (914) 847-5126

peter.dworkin@regeneron.com



manisha.narasimhan@regeneron.com

SOURCE Regeneron Pharmaceuticals, Inc.



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