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Teva Presents New Data Supporting Safety, Tolerability and Target Engagement of Anti-TL1A (TEV-574) Antibody at the 2024 ECCO Annual Meeting

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  Results demonstrate rapid and sustained suppression of free TL1A, confirming target engagement of anti-TL1A (TEV-'574)¹
  
  


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  Anti-TL1A (TEV-'574) was shown to be safe and well-tolerated, with a low incidence of antidrug antibodies²
  
  


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  Data support the ongoing Phase 2b clinical investigation of anti-TL1A (TEV-'574) in inflammatory bowel disease³
  
  

"These results from the first-in-human trials of anti-TL1A (TEV-'574) are exciting because they show that it effectively engages with the TL1A target, supports its safety profile and is well-tolerated. This aligns with our extensive pre-clinical evidence and further supports ongoing clinical investigations of anti-TL1A (TEV-'574) in IBD, where TL1A plays a prominent role in amplification of immune response leading to burdensome inflammation and fibrosis in the gastrointestinal tract," said Dr. Eric Hughes, Executive Vice President of Global R&D and Chief Medical Officer at Teva. "We are currently investigating the efficacy and safety of anti-TL1A (TEV-'574) in IBD through the RELIEVE UCCD Phase 2 trial, which features an innovative and efficient basket study design allowing the inclusion of patients with either type of IBD (ulcerative colitis and Crohn's disease). These data reinforce the potential for anti-TL1A (TEV-'574) to become a novel treatment option for IBD and solidifies our ongoing commitment to provide innovative medicines to improve the lives of people living with IBD, as quickly as possible."

First-in-human pharmacokinetic and safety data for anti-TL1A (TEV-'574) from a Phase 1 study in healthy volunteers and patients with mild asthma and a Phase 2 study in patients with severe asthma show:

• Dose-proportional increases in anti-TL1A (TEV-'574) exposure and minimal accumulation after multiple dosing every two weeks.¹
• A rapid and prolonged decrease in free TL1A levels indicating successful target engagement. This decrease was sustained up to two months after the last dose despite low or undetectable anti-TL1A (TEV-'574) levels.¹
• A favorable safety profile and well tolerated up to doses of 2300mg.^1,2

Also to be presented at ECCO 2024 is the study design of the RELIEVE UCCD Phase 2 trial investigating the efficacy and safety of anti-TL1A (TEV-'574) in patients with moderate-to-severe UC or CD.³ This first-ever basket study design for an IBD trial offers an efficient approach to help advance anti-TL1A (TEV-'574) to Phase 3 studies.

On November 30, 2023, Teva and Sanofi (EURONEXT: SAN and NASDAQ:SNY) announced the closing of their collaboration deal to co-develop and co-commercialize anti-TL1A (TEV-`574) for the treatment of UC and CD, two types of inflammatory bowel disease.⁴ Under the terms of the agreement, Teva received an upfront payment of $500 million shortly after closing and will receive 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.

About Inflammatory Bowel Disease

Inflammatory bowel disease (IBD) is the term for two conditions ― Crohn's disease (CD) and ulcerative colitis (UC) ― characterized by chronic inflammation of the gastrointestinal (GI) tract.⁵ CD and UC are chronic inflammatory conditions in the GI tract characterized by repetitive cycles of relapses and remission. Prolonged inflammation can lead to damage within the GI tract, including fibrosis, a common complication of IBD characterized by an excessive accumulation of scar tissue in the intestinal wall, which may cause narrowing and obstruction. Common symptoms of both conditions include persistent diarrhea, rectal bleeding, abdominal pain, loss of appetite, and weight loss. No cure exists for IBD - the goal of treatment is to induce and maintain remission and prevent flares.⁶ Globally, ~4.9 million cases of IBD have been identified, with incidence rising in several regions.⁷

About RELIEVE UCCD

RELIEVE UCCD is a 14-week Phase 2b, randomized, double-blind, dose-ranging study to determine the pharmacokinetics, efficacy, safety, and tolerability of anti-TL1A (TEV-'574) in adults with ulcerative colitis (UC) or Crohn's disease (CD). In the trial, patients who meet pre-specified inclusion criteria are randomized to subcutaneously receive either one of two anti-TL1A (TEV-'574) dose regimens or placebo in a 1:1:1 ratio (stratified by diagnosis [UC or CD] and previous exposure to advanced IBD therapy [biologics and small molecules]) for 14 weeks. Participants who complete the 14-week induction period have the option to enter the long-term extension (LTE), consisting of a 44-week maintenance period for responders and a re-induction period for non-responders. Primary efficacy endpoints for both the 14-week and 44-week LTE study are number of participants with moderate-to-severe UC who show clinical remission (as defined by the modified Mayo score) and the number of participants with moderate-to-severe CD who show an endoscopic response (as defined by the endoscopic score for CD). The trial includes sites in the U.S., Canada, Europe, and Asia.^8,9

About Anti-TL1A (TEV-'574)

Anti-TL1A (TEV-'574) is a potentially best-in-class human IgG1 monoclonal antibody that targets tumor necrosis factor (TNF)-like ligand 1A (TL1A), also known as TNF superfamily member 15. TL1A signaling is believed to amplify inflammation and drives fibrosis associated with asthma and inflammatory bowel disease (IBD); thus, targeting TL1A with TEV-'574 may mitigate the over-active immune response in these conditions. Anti-TL1A (TEV-'574) is currently in Phase 2b clinical trials for the treatment of ulcerative colitis (UD) and Crohn's disease (CD), two types of inflammatory bowel disease. The safety and efficacy of anti-TL1A (TEV-'574) have not been reviewed by any regulatory authority.

About Teva

Teva Pharmaceutical Industries Ltd. (NYSE and TASE:TEVA) is a global pharmaceutical leader with a category-defying portfolio, harnessing our generics expertise and stepping up innovation to continue the momentum behind the discovery, delivery, and expanded development of modern medicines. For over 120 years, Teva's commitment to bettering health has never wavered. Today, the company's global network of capabilities enables its 37,000 employees across 58 markets to push the boundaries of scientific innovation and deliver quality medicines to help improve health outcomes of millions of patients every day. To learn more about how Teva is all in for better health, visit www.tevapharm.com.

Cautionary Note Regarding 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 relating to: our ability to successfully compete in the marketplace, including our ability to achieve expected results from investments in our product pipeline including to successfully develop and commercialize our anti-TL1A (TEV-'574) asset for the treatment of ulcerative colitis and Crohn's disease, two types of inflammatory bowel disease; our exclusive collaboration with Sanofi; the risk that we will incur significant costs in connection with the development of anti-TL1A (TEV-'574), which may exceed any revenue generated by anti-TL1A (TEV-'574); risks that regulatory approvals and other requirements may delay the development and commercialization of our anti-TL1A (TEV-'574); 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; our business and operations in general, including the impact of global economic conditions and other macroeconomic developments and the governmental and societal responses thereto; the impact of the state of war declared in Israel and the military activity in the region, including the risk of disruptions to our operations and facilities, such as our manufacturing and R&D facilities, located in Israel; and other factors discussed in this press release and in our Annual Report on Form 10-K for the year ended December 31, 2023, 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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1. Balyan, R., Ghibellini, G., Sunzel, E. M. et al. (2024). P633 First-in-Human Pharmacokinetic and Safety Study of an Anti-TL1A Antibody, TEV-48574, in Healthy Volunteers and Asthma Patients. Journal of Crohn's and Colitis, 18(Supplement_1), i1215-i1216. https://doi.org/10.1093/ecco-jcc/jjad212.0763.
2. Raphael, G., Damera. G., Angeles, T. et al. (2024). P1061 TEV-48574, an anti-TL1A antibody in development for use in IBD, is safe and well tolerated following 16 weeks of subcutaneous treatment in adults with severe uncontrolled T2-low/non T2 asthma. Journal of Crohn's and Colitis, 18(Supplement_1), i1908-i1908. https://doi.org/10.1093/ecco-jcc/jjad212.1191.
3. Reinisch, W., Stoyanov, S., Raphael, G. et al. (2024). P998 Phase 2 basket design study evaluating the efficacy and safety of an anti-TL1A antibody (TEV-48574) in moderate to severe ulcerative colitis or Crohn's Disease (RELIEVE UCCD). Journal of Crohn's and Colitis, 18(Supplement_1), i1811-i1811. https://doi.org/10.1093/ecco-jcc/jjad212.1128.
4. Teva Completes Closing of Exclusive Collaboration Deal to Deliver Inflammatory Bowel Disease Treatment. https://ir.tevapharm.com/news-and-events/press-releases/press-release-details/2023/Teva-Completes-Closing-of-Exclusive-Collaboration-Deal-to-Deliver-Inflammatory-Bowel-Disease-Treatment/default.aspx. Accessed Feb 2024.
5. What is inflammatory bowel disease (IBD)? Centers for Disease Control and Prevention. 2022. Available at: https://www.cdc.gov/ibd/what-is-IBD.htm. Accessed Feb 2024.
6. McDowell, C., Farooq, U., & Haseeb, M. (2020). Inflammatory Bowel Disease (IBD). PubMed; StatPearls Publishing. https://www.ncbi.nlm.nih.gov/books/NBK470312/.
7. Dharni, K., Singh, A., Sharma, S. et al. Trends of inflammatory bowel disease from the Global Burden of Disease Study (1990-2019). Indian Journal of Gastroenterology (2023). https://doi.org/10.1007/s12664-023-01430-z.
8. A Study to Test the Effect of TEV-48574 in Moderate to Severe Ulcerative Colitis or Crohn's Disease (RELIEVE UCCD) https://clinicaltrials.gov/study/NCT05499130?term=TEV-48574&rank=2. Accessed Feb 2024.
9. A Study to Evaluate the Long-Term Effect of TEV-48574 in Moderate to Severe Ulcerative Colitis or Crohn's Disease. https://clinicaltrials.gov/study/NCT05668013?term=TEV-48574&rank=1. Accessed Feb 2024.

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