Sanofi partners with Janssen, Teva on E. coli, IBD treatments

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Sanofi announced separate collaborations this week with two pharmaceutical companies based in New Jersey: Janssen Pharmaceuticals Inc., a Johnson & Johnson company, and Teva Pharmaceuticals.

Sanofi, which also has a flagship location in the state, and Janssen entered an agreement to develop and commercialize the latter’s vaccine candidate for extraintestinal pathogenic E. coli (9-valent), which is currently in Phase 3. Under the agreement, the partners will co-fund current and future research and development costs, with Sanofi paying Janssen $175 million upfront, followed by development and commercial milestones.

According to Sanofi, the effort combines that company’s worldwide manufacturing footprint and expertise in launching innovative vaccines together with Janssen’s robust science.

“E. coli is a significant cause of sepsis, mortality, and antimicrobial resistance in older adults, and the number of cases is rising as the population ages,” said Thomas Triomphe, executive vice president, Vaccines, at Sanofi. “In line with our commitment to design and deliver first- or best-in-class medicines and vaccines, this agreement with Janssen aims to positively impact public health by reducing hospitalization costs and the burden on health systems associated with ExPEC and help older adults around the world to live longer, healthier lives.”

Invasive E. coli disease (IED) occurs when bacteria that normally resides in the intestines leave the intestinal tract and infect other parts of the body, according to Janssen.

“We’re committed to addressing the unmet need for a vaccine to protect against IED, which affects nearly 10 million adults each year, has only limited therapeutic options available and can cause life-threatening infections,” said Dr. Penny Heaton, global therapeutic area head, Infectious Diseases & Vaccines, for Janssen Research & Development LLC. “This agreement will enable us to accelerate the development and potential commercialization of this important preventive option.”

A profit-share arrangement will be established in the U.S.; France, Germany, Italy and Spain (EU4); and in the U.K. Throughout the rest of the world, Janssen will receive tiered royalties and sales milestones, according to the announcement.

Janssen, with locations in Raritan and Titusville, is in the midst of a name change to Johnson & Johnson Innovative Medicine, as part of a larger rebranding effort launched by Johnson & Johnson in September.

Closing is subject to customary regulatory clearance.

IBD

With Teva Pharmaceuticals, the Parsippany-based subsidiary of Israeli’s Teva Pharmaceutical Industries Ltd., Sanofi said the companies will co-develop and co-commercialize a treatment for two types of inflammatory bowel disease: ulcerative colitis and Crohn’s Disease.

Teva will receive an upfront payment of $500 million and up to $1 billion in development and launch milestones, under the agreement.

According to Sanofi, TEV’574 is currently in Phase 2b clinical trials. Initial program results are expected to be available in 2024.

Teva President and CEO Richard Francis described the effort as a new era for the company, adding that its “robust, innovative pipeline is key to our Pivot to Growth strategy,” which was announced earlier this year.

“This collaboration further validates the great science that Teva has to offer with our internally developed anti-TL1A,” Francis continued. “We are honored to partner with Sanofi to bring their proven capabilities, leadership, and success in the immunology and gastroenterology space together with our capabilities to optimize development and global launches.”

Each company will share global development costs equally as well as net profits and losses in major markets; other markets are subject to a royalty arrangement, Sanofi said, adding that it will lead the development of the Phase 3 program.

Teva will lead commercialization of the product in Europe, Israel and specified other countries, while Sanofi will lead in North America, Japan, other parts of Asia and the rest of the world.

The transaction will be effective after customary closing conditions are met.

An estimated 10 million people worldwide live with IBD, which is characterized by chronic inflammation of the gastrointestinal tract. Prolonged inflammation can cause damage to the area. Common symptoms for Crohn’s and UC include persistent diarrhea, rectal bleeding, abdominal pain, fatigue and weight loss.

“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,” commented Sanofi CEO Paul Hudson. “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.”