NASH drug development

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With a global market estimated at $35 billion, developing a drug to treat a form of fatty liver disease called non-alcoholic steatohepatitis or NASH could be the next big thing for the pharmaceutical industry. Attention to this disease is happening because of declining drug development elsewhere, the obesity epidemic and the ravaging impact on as many as 30 million people.

Declining Drug Development

Yes, oncology drugs contribute $200 billion to the pharmaceutical industry but in a very crowded developmental field. Past successes in other disease states mean there are fewer diseases looking for viable treatments. Statins to treat high cholesterol were blockbusters from two decades ago but now are available as cheaper generic drugs. Industry returns on R&D spending fell to 1.9% in 2018 from over 10% in 2010 according to Deloitte. Intense competition and pricing pressure are eroding sales of medicines for diabetes, rheumatoid arthritis and other lucrative disease categories. Being the first to market with an approved treatment for NASH could be incredibly lucrative.

Obesity

Obesity continues to be a major public health problem. A 2017 study by the NIH found that nearly 40% of U.S. adults are obese. Of those 89 million have nonalcoholic liver disease of which as many as 30 million people or 12% of U.S. adults have NASH. https://www.biopharmadive.com/news/nash-drug-pipeline-market-liver-disease/523492/ Weidong Zhong, CEO of Terns Pharmaceuticals, a start-up incubating drugs to treat NASH said obesity, “is a major global problem, especially in China. In the past twenty years, obesity rates are soaring there and 43% of the population now has fatty liver disease.” The rising obesity rates at all ages mean liver specialists are seeing people in the 20s and 30s with NASH. Dr. Leona Kim-Schluger, a hepatologist at Mount Sinai Hospital in New York notes, “There is even NASH in the pediatric population.”

Asymptomatic

One of the difficulties with NASH is that it often isn’t diagnosed until it is in a late stage when cirrhosis starts to ravage the body and the only treatment available is a liver transplant. Dr. Maria Yataco, a gastroenterologist at Mayo Clinic, says, “By 2020 NASH will overtake hepatitis C as the No. 1 cause of liver transplantation in the U.S.” Other effects of NASH include fibrosis, fluid accumulation in the abdomen, bleeding in the esophagus and liver cancer. The only way to catch the disease at an earlier stage is a liver biopsy. Identifying patients from a typical physical exam isn’t currently possible. Less invasive methods of diagnosing the disease are as important as developing an effective medicine.

Who will be first to market?

BioMedtracker, a product from business intelligence firm Informa, counts 55 NASH drugs in clinical trials: 19 at Phase 1, 33 at Phase 2 and 4 at Phase 3. The four companies in Phase 3 are leading the effort to commercialize a drug to reverse the effects of NASH: Intercept Pharmaceuticals, Gilead Sciences , Allergan and French biotech GENFIT. After successfully curing hepatitis C with a whole new class of blockbuster direct-acting antiviral drugs, Gilead Sciences is poised to conquer the next big frontier in liver disease. Intercept already has a drug called Ocaliva with FDA approval to treat another liver disease. “It is a molecule 100 times more potent than human bile acid that amplifies the liver’s ability to regenerate,” says Dr. Mark Pruzanski, President of Intercept. “What we’re doing is trying to build a future without liver cirrhosis so people can avoid transplants.”

An exciting time to work in the pharmaceutical industry. Interested in discussing your career or your hiring needs? Contact Smith Hanley Associates’ Biostatistics Recruiter, Nihar Parikh, at [email protected].


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