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30 October 2018Americas

Novartis and Pfizer sign clinical development agreement

Swiss pharmaceutical company Novartis has partnered with Pfizer, its American rival, in efforts to advance the treatment of non-alcoholic steatohepatitis (NASH).

The non-exclusive clinical development agreement, announced yesterday, October 29, will include a study to evaluate the effect that combinations of Novartis’s Tropifexor (LJN452) and Pfizer’s investigational therapies will have for the treatment of NASH.

According to Novartis, NASH, the progressive form of non-alcoholic fatty liver disease, is a “complex condition with no currently available treatment options” and affects up to 6.5% of the population worldwide.

Novartis is developing Tropifexor, a farnesoid X receptor (FXR, also known as the bile acid receptor) agonist for the treatment of NASH. Tropifexor is an oral treatment designed to address certain features of NASH, such as the fat build-up in the liver, inflammation, and fibrosis.

Novartis said that early animal studies with Tropifexor have shown a reduction of fat accumulation in the liver. The US Food and Drug Administration granted the FXR ‘fast track’ designation for NASH with liver fibrosis in October 2016.

Under the agreement, the companies will conduct non-clinical and phase 1 clinical studies of Pfizer’s investigational therapies together with Tropifexor, according to a statement made by Pfizer.

Pfizer noted that NASH is expected to be the leading cause of liver transplants within the next decade.

Morris Birnbaum, senior vice president and chief scientific officer of internal medicine at Pfizer, said: “We are confident that by drawing from our history and deep understanding of the close interplay between metabolic, inflammatory and cardiovascular conditions, we can potentially uncover treatments that truly meet patient needs.”

Eric Hughes, global development unit head of immunology, hepatology, and dermatology at Novartis, said: “Liver diseases, including NASH, are multifaceted with various factors that contribute to the progression of the disease. This makes them difficult to treat with a single compound.”

He added: “We want to collaborate with multiple partners to drive the science and understanding of how to treat non-viral liver diseases. Targeting different pathways in NASH with a broad array of therapies is an essential strategy to bring the best treatments to patients.”

In March 2017, Novartis announced a clinical trial collaboration with Allergan for the treatment of NASH fibrosis combining Tropifexor and cenicriviroc, a once-daily, oral immunomodulator.

Financial terms of the agreement between Novartis and Pfizer have not been disclosed.

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