NASH Pipelines Face Questions as Drugs Near Potential Approval

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There are dollar signs in the treatment of nonalcoholic steatohepatitis (NASH). The market is pegged to hit $25 billion by 2026 and companies are flooding the developmental pipeline with potential treatments for a disease that has no approved therapies in the United States.

The prevalence of NASH, a severe form of non-alcoholic fatty liver disease (NAFLD), is increasing worldwide in part due to the increase in obesity and diabetes diagnoses. Excessive accumulation of fat in the liver induces chronic inflammation, which causes progressive fibrosis, cirrhosis and eventually end-stage liver disease. In the United States NASH affects 2 to 5 percent of people. In China, it is estimated that 15 percent of the adult population has NAFLD and of those about 20 percent will develop NASH. 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.

In a recent deep dive on the NASH market and potential treatments, BioPharma Dive noted there about 195 treatments in the pipeline of various companies. As it stands, most of the therapies are in early- or mid-stage development and those that are in late-stage studies are still a year or more away from potential approval. Multiple companies are focused on the development of Nash drugs, including startup company Terns Pharmaceuticals, which licensed three NASH programs from Eli Lilly. Companies like AstraZeneca, Takeda Pharmaceuticals, Allergan and Gilead Sciences have all invested heavily into the space. In 2016 Allergan went on a buying spree to acquire multiple NASH developmental products. In 2016 Bristol-Myers Squibb slammed down $100 million to acquire rights for a NASH program from Osaka, Japan-based Nitto Denko Corporation. In April La Jolla, Calif.-based MediciNova halted a Phase II NASH trial following an interim analysis that showed its experimental treatment, MN-001 (tipelukast), yielded significant positive results in the treatment of patients with NASH and non-alcoholic fatty liver disease (NAFLD) with hypertriglyceridemia.

One of the key issues facing the market actually revolves around the diagnosis of the disease. NASH can be difficult to catch in an early diagnosis and can take years before patients show any sort of symptoms. BioPharma Dive pointed to the fact that NASH often goes hand-in-hand with other problems, like diabetes or cardiovascular issues. That can lead to physicians determining which indication is more pressing in their treatment decisions, BioPharma Dive noted in its report.

“The commercial strategy for these drugs will need to provide a clear case for why to treat those patients now, especially with all of their other co-morbidities like diabetes and heart disease — those are the things clinicians are trained to worry about first,” Greg Rotz, principal in PwC's Advisory business, told BioPharma Dive.

But, there will certainly be room for diagnostic advances in NASH, which will likely revolve around less invasive forms of diagnosis. Currently, the disease is determined through a biopsy.

Another key that will affect pharma companies down the road will be pricing. The companies will have to determine what price points will be acceptable to payers. In speaking with multiple pricing experts, BioPharma Dive noted that some analysts worry that NASH drugs could go the way of Hepatitis treatments that were expensive, but were ultimately seen as cures for the disease.

“Considering the current pricing environment, the unmet medical need, and the symptomless nature of the disease, it will be tricky for pharma to find that sweet spot when it comes to setting a price,” BioPharma Dive noted.

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