(National Library of Medicine, NIH)
6 January 2015. Biopharmaceutical company Gilead Sciences bought an experimental drug to treat non-alcoholic liver diseases from Phenex Pharmaceuticals AG, a German biotechnology firm. Gilead, in Foster City, California, is expected to pay Phenex up to $470 million for the drug.
Under the deal, Gilead acquires Phenex’s work developing a drug that binds to and activates the Farnesoid X receptor, a protein for converting DNA into chemical signals to cells in the body, in this case cells in the liver regulating metabolism of lipids — fats and oils — and insulin sensitivity. Phenex developed the drug, code-named Px-104, as a treatment for two related disorders, nonalcoholic fatty liver disease and nonalcoholic steatohepatitis. Both conditions are the result of fat build-up in the liver, and believed to be associated with rising obesity rates in developed countries.
Accumulation of fat in the liver is not considered a normal condition, but it is becoming less uncommon. National Institute of Diabetes and Digestive and Kidney Diseases estimates 10 to 20 percent of Americans have nonalcoholic fatty liver disease, defined as excess fat in the liver, but with few observable symptoms, and no inflammation or scarring. When combined with obesity, a sedentary lifestyle, or metabolic syndrome the condition can result in inflammation in the liver, or nonalcoholic steatohepatitis, that affects the liver’s ability to function properly. While nonalcoholic steatohepatitis affects a much smaller percentage of Americans (2 to 5%), if left untreated it can lead to cirrhosis, or scarring in the liver, and eventually liver cancer or failure.
Phenex, based in Ludwigshafen, Germany, says Px-104 acts by lowering lipids in the liver as well as improving sensitivity to insulin. The company says its research with lab animals shows Px-104 helps reduce liver inflammation and fibrosis or scarring. In addition, early-stage clinical trials with healthy volunteers show an earlier form of the drug (Px-102) is safe and well-tolerated. An intermediate-stage clinical trial with patients having nonalcoholic fatty liver disease is recruiting participants.
Under the deal, Gilead gains control of Phenex’s development program for Px-104, although Phenex is expected to collaborate with Phenex in further development of the drug. Gilead plans to pay Phenex $470 million in initial and staged payments keyed to developmental milestones, although the initial payment amount was not disclosed.
In December 2012, Phenex and Janssen Biotech — a division of Johnson & Johnson — agreed to collaborate on discovering drugs treating chronic inflammatory and autoimmune disorders, based on a similar technology developed by Phenex. That deal makes Phenex eligible for up to $135 million in milestone payments, as well as royalties on subsequent product sales.
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