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Big drug companies are constantly on the lookout for smaller companies with promising new drugs about to come to market. Often, the hunt is on for a class of drugs designed to combat a disease or condition that hasn’t had a lot of research but does have a great deal of potential in terms of the number of patients.

One recent disease du jour is Non-Alcoholic SteatoHepatitis (NASH). NASH is a progressive fatty liver disease which experts say will be the leading cause of liver transplants by 2020.


Huge Potential Market

Eventually, the market for NASH is predicted to be between $20 billion and $35 billion. It will be most prevalent in countries with fatty diets. Obviously the U.S. falls into that category. There are currently no approved treatments for NASH.

Meanwhile, competition and pricing pressure have cut into sales of meds for diabetes, rheumatoid arthritis and other diseases that formerly fed cash to big pharma. NASH, it seems, is coming along at a good time for drug companies – assuming treatments develop.

Companies Looking To Cash In

Among drug companies currently developing their own drugs are Pfizer (NYSE:PFED), which has 3 early-stage drugs in clinical trials and Bristol-Myers Squibb (NYSE:BMYC), which recently confirmed it is looking to develop NASH drugs in-house.

Only a few years ago Gilead Sciences (NASDAQ:GILDC) was the lone drugmaker discussing NASH. Gilead has one failure but has since struck deals with two small companies involved in NASH research. Others in the mix include Allergan (NYSE:AGNB), Novartis AG (NYSE:NVSC), Merck & Co (NYSE:MRKC) and Johnson & Johnson (NYSE:JNJC).

Smaller Players Are Also Active

While big pharma has been aggressive, small companies like NGM Bio are also looking to get into the mix. NGM Bio has what it believes is a strong candidate, injectable NGM282, which met its primary endpoint of reducing liver fat against a dummy treatment over 12 weeks.

NGM Bio president, Jeff Jonker, said that although the study was not powered to see an improvement in fibrosis, “biomarkers of fibrosis were examined as exploratory endpoints in the study and we see statistically significant results from several.”


Patient Recruitment A Problem

One company, Genfit, has struggled to recruit patients to its phase 3 NASH trials, thanks to the explosive growth in NASH related research in recent months. The French-based biotech said in Q1 results that recruitment of the first 1,000 patients into its phase 3 RESOLVE-IT trial could be delayed 4 to 6 months.

The company said it had plenty of patients with less severe (F1) fibrosis, it is having great difficulty finding patients that fit into the more severe F2 and F3 stages. According to Genfit the delay is partly due to the increasing number of clinical trials now being launched in NASH. It is also attributable to Genfit’s desire to ensure enrollment quality in order to produce the most statistically robust clinical trial.

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