The $40 Billion NASH Market and the 3 Biotechs That Stand to Profit From it

The $40 Billion NASH Market and the 3 Biotechs That Stand to Profit From it November 1, 2016
By Alex Keown, Breaking News Staff

NEW YORK – The treat non-alcoholic steatohepatitis (NASH) market is huge, estimated to reach $40 billion by 2025, according to analyst predictions. It’s no wonder multiple companies are devoting resources to develop therapies for the liver disease. And investors should take note of three companies, Gilead Sciences , Intercept Pharmaceuticals and Allergan , which are leading the way.

The prevalence of NASH is increasing worldwide in part due to the increase of obesity and diabetes diagnoses. According to the National Institute of Diabetes and Digestive and Kidney Diseases, NASH affects 2 to 5 percent of people in the U.S. There are currently no specific treatments aside from weight loss, increased physical activity and avoiding alcohol and unnecessary medications. NASH is projected to become the leading indication for liver transplant by 2020.

1. Allergan

In order to develop a NASH pipeline, Allergan has been snapping up multiple companies focused on NASH treatments this year, including Akarna Therapeutics, Ltd. and Tobira Therapeutics . Brent Saunders, Allergan’s president and chief executive officer, said NASH will become a chronic disease of epidemic proportions. Because of that, the company is investing heavily in new treatments. With the acquisitions, Allergan brought the experimental small molecule, non-bile acid FXR agonist, AKN-083, into its pipeline from Akarna. The acquisition of Tobira brought two NASH programs, enicriviroc (CVC) and Evogliptin, into the pipeline.

2. Gilead

Gilead already leads the market in hepatitis C treatments with its blockbuster drugs Harvoni and Sovaldi, but with those markets declining, the company is looking at other liver diseases, including NASH. Earlier this year, Gilead Sciences snapped up Cambridge, Mass.-based Nimbus Apollo, Inc. for its Acetyl-CoA Carboxylase (ACC) inhibitor program in an effort to bolster the company’s pipeline for metabolic disorders and the treatment of non-alcoholic steatohepatitis (NASH). The addition of NDI-010976 will back up NASH research Gilead is conducting with its investigational monoclonal antibody simtuzumab, which was acquired from Arresto Biosciences in 2011. In total, Gilead has five candidates, including standalone and combination, therapies for NASH in its pipeline. NDI-010976 was granted Fast Track designation by the U.S. Food and Drug Administration (FDA) in February.

3. Intercept Pharmaceuticals

New York-based Intercept is aiming its drug Ocaliva, FXR agonist, which has already been approved for another liver disease, primary biliary cholangitis, at NASH. The drug is currently in late-stage trials for NASH and is expecting interim data in the first half of 2017. NASH is a more common liver disease than PBC, which would give Ocaliva a much wider target audience, generating more revenue for the company.

Other companies are also developing treatments for NASH. In 2015, San Diego-based startup Metacrine, Inc. launched with goals of developing treatments for NASH and other liver disorders. Although the company has remained tight-lipped about its approaches, its therapies are armed with a therapy acquired from the Salk Institute.

Writing for The Motley Fool, Keith Speights speculated that of the three companies, Gilead has the cash reserves to ensure it’s the company to beat when it comes to NASH treatments. Gilead, Speights said, has about “$24.6 billion in cash, cash equivalents, and marketable securities that it can use if necessary.” There are also questions as to whether or not Gilead will snap up Intercept—a rumor that was making the rounds earlier this year.

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