IBD, Crohn's disease, ulcerative colitis
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Sanofi and Teva Pharmaceuticals yesterday announced a collaboration to co-develop and co-commercialize TEV’574, a TL1A inhibitor currently in Phase IIb clinical trials for the treatment of ulcerative colitis and Crohn’s disease, two types of inflammatory bowel disease (IBD). The deal is worth potentially $1.5B overall, with $500M upfront.  Teva Pharmaceuticals is a U.S. subsidiary of Tel Aviv-based Teva Pharmaceutical Industries Ltd.

The global IBD market is estimated to be worth more than $20B, and anti-TL1A offers a new category that is heating up. Recent studies show TL1A (Tumor necrosis factor-like cytokine 1A) acts as a regulator of mucosal immunity and acts in immunological pathways involved in the IBD pathogenesis.

In December of last year Roivant teamed up with Pfizer to develop its RVT-3101. Roivant announced “best-in-indication potential” results in January of this year from its global Phase IIb trial overall, and in the biomarker positive patients.

In April of this year Merck bought Prometheus Biosciences in a $10.8 billion deal that included the biotech’s lead candidate, PRA023—an anti-TL1A humanized monoclonal antibody. In December 2022, the company had announced positive results for PRA023 from ARTEMIS-UC, a Phase II study in patients with moderate to severely active ulcerative colitis and APOLLO-CD a Phase IIA in patients with Crohn’s.

“Anti-TL1As are a promising class of therapies, and we believe that TEV’574 could emerge as a best-in-class option for people living with serious gastrointestinal diseases,” said Paul Hudson, CEO, Sanofi.

He added that, “This collaboration strengthens our commitment to advancing innovative treatment options for inflammatory conditions with a high unmet need and bolsters our goal to be an industry leader in immunology.”

Under the terms of the agreement, Teva will receive an upfront payment of €469 million ($500 million) and up to €940 million ($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. The transaction will become effective after customary closing conditions are met. Initial program results are expected to be available in 2024.

“This is a new era for Teva, and our robust, innovative pipeline is key to our Pivot to Growth strategy. This collaboration further validates the great science that Teva has to offer with our internally developed anti-TL1A,” said Richard Francis, president and CEO, Teva.

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. Current leading therapies do not induce a response in about a-third of patients, and 40% of the rest lose response over time.

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