Teva Presents New Data Supporting Safety, Tolerability and Target Engagement of Anti-TL1A (TEV-‘574) Antibody at the 2024 ECCO Annual Meeting - Seite 2

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