Sanofi and ImmuNext Enter into Agreement to Develop Treatments for Autoimmune Diseases

BRIDGEWATER, N.J. and LEBANON, N.H., Jan. 9, 2017 /PRNewswire/ -- Sanofi and ImmuNext, Inc., announced today an agreement focused on the development of a novel antibody with the potential to treat a range of autoimmune diseases including Lupus and Multiple Sclerosis. Under the terms of the agreement, ImmuNext will grant Sanofi an exclusive, worldwide license to develop and commercialize INX-021, a CD40L monoclonal antibody in preclinical development that suppresses the activity of a cellular pathway that is overactive in many autoimmune diseases. In addition, Sanofi and ImmuNext will initiate a research collaboration to support clinical trials. ­

Potential milestone payments to ImmuNext under the agreement could total $500 million. ImmuNext is also eligible to receive tiered royalties up to double digits on sales of products.

"The immunoregulatory molecule, CD40L, is critical to the progression of a wide spectrum of autoimmune diseases," said Randolph Noelle, Ph.D., co-founder and Chief Scientific Officer of ImmuNext and Professor of Microbiology and Immunology, Geisel School of Medicine, Dartmouth College. "Antibodies that block the function of CD40L have proven in pre-clinical models of autoimmunity to be amongst the most effective agents in treating disease. The development of anti-CD40L for the treatment of autoimmune diseases offers a unique opportunity to silence disease progression and offer long-term remission."

"Sanofi is committed to expanding our pipeline of specialty care products in multiple sclerosis, where we have established a strong foundation, and immunology, where we are poised to launch new treatments this year for atopic dermatitis and rheumatoid arthritis," said Frank Nestle, Global Head of Immunology & Inflammation Research Therapeutic Area and also North America Chief Scientific Officer. "We are excited to collaborate with Dr. Noelle and the team at ImmuNext on this promising endeavor."

About Sanofi
Sanofi, a global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Sanofi is organized into five global business units: Diabetes and Cardiovascular, General Medicines and Emerging Markets, Sanofi Genzyme, Sanofi Pasteur and Consumer Healthcare. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).

About ImmuNext, Inc.
ImmuNext develops compounds on the cutting edge of immunotherapy for cancer and autoimmune diseases.  Our lead product, anti-VISTA, is partnered with Janssen for the treatment of cancer.  Our second product, VISTA agonists, is partnered with Hoffmann-La Roche for the treatment of autoimmune diseases. Other programs include a CD40 agonist for neoantigen cancer vaccines and a novel immuno-metabolic target, in each case establishing new classes of compounds. 

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 regarding the marketing and other potential of the product, or regarding potential future revenues from the product. Forward-looking statements are generally identified by the words "expects", "anticipates", "believes", "intends", "estimates", "plans", "looks forward" 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, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the absence of guarantee that the product will be commercially successful, the uncertainties inherent in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and volatile economic conditions, as well as those risks 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, 2015. 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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SOURCE Sanofi