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In Depth Review of Gilead Sciences’ NASH Pipeline Opportunities


Oct. 13 2016, Updated 8:04 a.m. ET

NASH market potential

Nonalcoholic steatohepatitis (or NASH) doesn’t have any existing approved treatments on the market, but a number of companies are vying for a share of the untapped market, which is estimated to be worth $20 billion by 2025. According to Gilead Sciences (GILD), approximately 15 million people in the United States are estimated to be suffering from NASH. Investors interested in gaining exposure to Gilead Sciences and participating in its growth potential can invest in the Vanguard Growth ETF (VUG), which holds ~1.1% of its total portfolio in Gilead Science.

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Gilead’s NASH pipeline

Gilead Sciences has a strong opportunity for growth with the company’s NASH product pipeline, which might gradually offset its revenue deceleration due to the company’s weakening HIV and HCV sales. Gilead Sciences aims to develop a comprehensive NASH portfolio. It has four drugs in its pipeline for the treatment of NASH, including Simtuzumab, ASK1 inhibitor GS-4997, FXR agonist GS-9674, and NDI-010976 with other preclinical ACC inhibitors. These drugs are being developed to target different disease areas and they could be used in combination. Phase two data readouts for Simtuzumab and GS-4997 are expected to be released in 2H16.


Intercept Pharmaceuticals (ICPT) is a small New-York-based pharmaceutical company established in 2012 that is well ahead of behemoths like Gilead Sciences and Allergan (AGN) that are actively pursuing the NASH space. Intercept began its phase three trials for its NASH drug, Obeticholic Acid, in September 2015. Gilead Sciences acquired Nimbus Therapeutics in April 2016, thereby expanding its NASH product pipeline. For more on the acquisition, read Gilead Sciences Focuses on a Strong Inorganic Growth Strategy.

Allergan acquired Tobira Therapeutics and entered the NASH market in September 2016. Tobira’s potential NASH drug, Cenicriviroc, is under phase two clinical trials. Shire’s (SHPG) candidate, SHP626 (or Volixibat), is another competitive NASH drug that gained FDA fast-track approval in August 2016 and is undergoing phase two trials.


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