March 3, 2017
By Mark Terry, BioSpace.com Breaking News Staff
Swiss-based Novartis is believed to be in talks to buy France-based Genfit , according to insider sources.
Genfit took a big jump at the news, rising from 21.29 Euros on March 1 to a current trading value of 28.92 Euros. The current exchange rate is 1.06 U.S. dollars to one Euro.
Genfit headquarters are in France, with a U.S. site in Cambridge, Mass. The company is focused on metabolic diseases related to obesity. Its lead pipeline product is elafibranor (GFT505) for nonalcoholic steatohepatitis (NASH) to prevent fibrosis progression. It is currently being studied in a Phase III trial, RESOLVE-IT.
NASH, sometimes called the “silent liver disease,” resembles alcoholic liver disease, but appears in people who drink little or no alcohol. However, it can be quite severe and lead to cirrhosis. 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.
Genfit has projected the worldwide market for NASH treatments to exceed $30 billion. However, some analysts believe that’s unrealistic due to an assumption that 85 percent of the NASH population could be treated, which equates to a global NASH market size of around $30 to $40 billion.
There is a range of severity in NASH patients, and the advanced fibrosis stage (F3/F4) is when patients generally note symptoms that make them feel poorly and want treatment. A more conservative estimate for the addressable NASH patients is about 6 to 10 million patients, which would make the global NASH market size at least $10 billion.
Dublin-based Allergan made several strategic acquisitions last year in the NASH market, buying San Francisco-based Tobira Therapeutics for a deal that could add up to $1.695 billion. Tobira has two complementary development programs, Cenicriviroc (CVC) and Evogliptin, for NASH. And also in September, it acquired Akarna Therapeutics, headquartered in San Diego. Akarna’s lead candidate is also a NASH product.
With a wide-open market and no treatments, many companies are showing an interest in the NASH market. Other leaders in the area include Intercept , Gilead , Novo Nordisk , Shire , Galmed and Contus.
There were rumors last year that Novartis was considering buying Intercept.
In a February 8 report Genfit indicated, “Subject to satisfactory clinical results obtained during the first stage of this study (RESOLVE-IT) in a first group of approximately 1,000 patients, which GENFIT anticipates can be recruited by the Summer of 2017 and the authorization of the regulatory agencies, a conditional marketing authorization could be obtained for elafibranor in NASH during the course of the second half of 2019 or first half of 2020.”
The company also received approval from the U.S. Food and Drug Administration to start a Phase II trial of elafibranor in Primary Biliary Cholangitis (PBC). PBC is a rare, chronic disease characterized by the gradual destruction of the liver’s bile ducts, which inhibits the liver’s ability to clear the body of toxins. It can lead to liver tissue scarring, in other words, cirrhosis. The first patient is expected to be recruited in Spring 2017.
Genfit is also exploring potential combination therapies using elafibranor in NASH with other Genfit programs, as well as other products in development for NASH. The company also has other biomarkers under development for the diagnosis of NASH. The current approach to a definitive diagnosis is through expensive and invasive liver biopsies.
