Gilead Sciences announces the acquisition of Phenex Pharmaceuticals’ development program for non-alcoholic steatohepatitis (NASH) and other liver diseases.

Gilead Sciences and Phenex Pharmaceuticals announced the signing of a definitive agreement under which Gilead will acquire Phenex’s Farnesoid X Receptor (FXR) program comprising small molecule FXR agonists for the treatment of liver diseases including non-alcoholic steatohepatitis (NASH). Under the terms of the agreement, Gilead will pay Phenex an upfront payment plus additional payments based upon the achievement of certain development milestones that may potentially be worth up to $470M.

NASH is a common, yet serious chronic liver disease characterized by inflammation and excessive fat accumulation in the liver and may lead to progressive fibrosis, cirrhosis and liver failure. The disease is estimated to affect 10 to 20% of people in the developed world but there are currently no approved therapies to treat it. Phenex’s program is based on FXR, a nuclear hormone receptor highly expressed in the liver and the intestine, which regulates bile acid, lipid and glucose homeostasis. Pharmacological activation of the FXR receptor by synthetic agonists attacks the underlying causes of NASH, lowering liver lipids and improving hepatic insulin sensitivity. The treatment will be combined with a liver specific anti-fibrotic and anti-inflammatory effect.

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Dr. Claus Kremoser, CEO of Phenex Pharmaceuticals, said, “This agreement represents a significant milestone for our company and for the field of liver disease research. After 15 years of research, FXR is now one of the few clinically validated targets for NASH and we are delighted that Gilead will be continuing the research necessary to more fully realize its potential for advanced liver disease.

Last Ocotber, we met Dr. Kremoser in a conference where he told us the story of his company: in December of 2013 everything almost ended for Phenex. FXR program was in clinical stage in Vienna. The 4th patient of the study had showed heart problems side-effects due to the treatment and it seemed that everything needed to be cancelled. But in the same time a US-based company, Intercept, was developing the same agonist. In 2014 they were developing a Phase II and they went public with a 70 million stock exchange introduction. This showed to Phenex that they were not worried about the Vienna event because they knew that their product wasn’t producing side-effects. Fortunately, Phenex has also kept a back-up molecule in the pipeline and went to Phase II at the beginning of 2014. Despite its previous bad results in Vienna, Phenex has been contacted by 14 US companies interested in partnerships because on contrary to the Intercept’s candidate, the new Phenex’s molecule was not increasing HDL/LDL ratio in patients. Now, we know that Gilead win the bid to gain control over FXR program.

While the incidences of NASH are dramatically rising worldwide, a new hope comes from the acquisition of Phenex’s FXR program by Gilead, which represents an important opportunity to develop new treatment options for fibrotic liver diseases.

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