Teva Pharmaceuticals, a U.S. subsidiary of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) announced today closing of its collaboration deal to co-develop and co-commercialize asset TEV ‘574 with Sanofi (EURONEXT: SAN and NASDAQ: SNY). TEV '574 is currently in Phase 2b clinical trials for the treatment of ulcerative colitis and Crohn's disease, two types of inflammatory bowel disease.
As announced on October 4th, 2023, under the terms of the agreement, Teva will receive an upfront payment of $500 million shortly after closing and up to $1 billion in development and launch milestones. Each company will equally share the development costs globally and net profits and losses in major markets, with other markets subject to a royalty arrangement and Sanofi will lead the development of the Phase 3 program. Teva will lead commercialization of the product in Europe, Israel and specified other countries, and Sanofi will lead commercialization in North America, Japan, other parts of Asia and the rest of the world. Initial program results are expected to be available in 2024.
Inflammatory bowel disease (IBD) is the term for two conditions -- Crohn’s disease and ulcerative colitis – characterized by chronic inflammation of the gastrointestinal (GI) tract. Prolonged inflammation results in damage to the GI tract. The common symptoms for both conditions are persistent diarrhea, rectal bleeding, abdominal pain, fatigue, and weight loss. An estimated ~10 million people worldwide live with IBD.
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) has been developing and producing medicines to improve people’s lives for more than a century. We are a global leader in generic and innovative medicines with a portfolio consisting of over 3,500 products in nearly every therapeutic area. Around 200 million people around the world take a Teva medicine every day and are served by one of the largest and most complex supply chains in the pharmaceutical industry. Along with our established presence in generics, we have significant innovative medicines research and operations supporting our growing portfolio of innovative medicines and biopharmaceutical products. Learn more at www.tevapharm.com.
Cautionary Note of Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. You can identify these forward-looking statements by the use of words such as “should,” “expect,” “anticipate,” “estimate,” “target,” “may,” “project,” “guidance,” “intend,” “plan,” “believe” and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance. Important factors that could cause or contribute to such differences include: risks related to our exclusive collaboration with Sanofi and the timing of and our ability to achieve expected results for TEV ‘574 (anti-TL1A), including our ability to commercialize TEV ‘574; the extent to which we will realize the anticipated financial and other benefits of the Sanofi collaboration; our ability to satisfy the conditions to receiving milestone cash payments under the Sanofi collaboration agreement; the risk that we will incur significant costs in connection with the development of TEV ‘574, which may exceed any revenue generated by TEV ‘574; risks that regulatory approvals and other requirements may delay the development and commercialization of TEV ‘574; our ability to successfully compete in the marketplace, including our ability to develop and commercialize biopharmaceutical products, competition for our innovative medicines, including AUSTEDO®, AJOVY® and COPAXONE®, our ability to achieve expected results from investments in our product pipeline, our ability to develop and commercialize additional pharmaceutical products, and the effectiveness of our patents and other measures to protect our intellectual property rights including any potential challenges to our Orange Book patent listings in the U.S.; our ability to successfully launch and execute our Pivot to Growth strategy, including to expand our innovative and biosimilar medicines pipeline and profitably commercialize the innovative medicines and biosimilar portfolio, whether organically or through business development, and to sustain and focus our portfolio of generics medicines; our substantial indebtedness; our business and operations in general, including, the impact of global economic conditions and other macroeconomic developments and the governmental and societal responses thereto, and costs and delays resulting from the extensive pharmaceutical regulation to which we are subject; compliance, regulatory and litigation matters, including failure to comply with complex legal and regulatory environments; other financial and economic risks; and other factors discussed in our Quarterly Report on Form 10-Q for the third quarter of 2023 and in our Annual Report on Form 10-K for the year ended December 31, 2022, including in the section captioned “Risk Factors.” Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements.
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