Sanofi US to co-promote teplizumab, adding it to its current commercial activities in diabetes care, leveraging its existing best-in-class customer-facing field teams Provention Bio, Inc. retains all rights to teplizumab Commercialization activities are dependent on U.S. FDA approval of teplizumab, potentially on November 17, 2022.
BRIDGEWATER, N.J., Oct. 6, 2022 /PRNewswire/ --Sanofi US has announced it has entered into a co-promotion service agreement with Provention Bio, Inc., for the commercialization of teplizumab in the United States. Teplizumab, developed by Provention, is an investigational anti-CD3 monoclonal antibody that is being evaluated for the delay of clinical type 1 diabetes (T1D) in at-risk individuals, as indicated by the presence of two or more T1D-related autoantibodies. If approved by the U.S. Food and Drug Administration (FDA), teplizumab would be the first-ever disease-modifying therapy in T1D. Pending FDA approval, Sanofi US will co-promote teplizumab along with its existing portfolio of diabetes therapies, and leverage its customer-facing field teams with the aim of accelerating uptake of teplizumab across the U.S. Olivier Bogillot Jason Hoitt The FDA is expected to make a decision on the regulatory approval for teplizumab on November 17, 2022. Agreement Terms As of the effective date of the service agreement, Sanofi US has committed to make an upfront payment of $20 million to Provention Bio. In connection with this transaction, Provention Bio has granted Sanofi US an exclusive right of first negotiation for a potential in-license agreement of teplizumab in T1D. Sanofi US also has agreed to make an equity investment of $35 million in Provention Bio, within a defined period after FDA approval of teplizumab, should this take place. About type 1 diabetes Living with T1D is complex. In addition to daily insulin injections or infusion via an insulin pump, people living with T1D also need to adopt a strict management plan which includes regular blood sugar monitoring, healthy diet and physical activity. About Sanofi Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY Media Relations Investor Relations 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” 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 fact that product may not 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 and market conditions, and the impact that COVID-19 will have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. Any material effect of COVID-19 on any of the foregoing could also adversely impact us. This situation is changing rapidly and additional impacts may arise of which we are not currently aware and may exacerbate other previously identified risks. The risks and uncertainties also include the uncertainties 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, 2021. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. SOURCE Sanofi | ||
Company Codes: NASDAQ-NMS:SNY, EuronextParis:SAN |
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