Madrigal Pharmaceuticals has hired Carole Huntsman as its new chief commercial officer to help the biotech navigate a new and potentially tricky launch in nonalcoholic steatohepatitis (NASH).
This comes after Madrigal started a rolling submission with the FDA for resmetirom in NASH, a form of fatty liver disease, back in the summer.
It has since revealed more positive data demonstrating the experimental drug's efficacy in reducing fat in the liver. An FDA decision on the drug is anticipated by March 14. If all goes well (though in NASH, that is far from certain), a launch could occur later in the year, marking the first approval for a drug targeting this condition.
Madrigal, hoping the FDA will give it the green light for a launch, has hired Huntsman to help shore up the company and transform it from an R&D biotech into a commercial outfit and help push the drug’s trajectory as high as possible. She has some strong credentials, having most recently served as senior vice president and head of specialty care for North America and U.S. country lead at Sanofi.
There, she helped launch Dupixent, the immunology drug co-marketed by Sanofi and Regeneron, into what has become a megablockbuster franchise.
Huntsman comes on board with another former Sanofi alum in the guise of Madrigal’s new CEO Bill Sibold, who also worked at the French Big Pharma, most recently as its executive vice president of specialty care and president of North American operations.
He took over in September, leading to a wobble in the company’s stock price as investors questioned the company’s decision to change leaders so close to its potential launch date.
Selling the drug for NASH may pose a greater challenge for the Sanofi veterans. This condition, affecting tens of millions of Americans, is commonly associated with obesity and can, in some instances, lead to liver damage, increasing the risk of liver failure and death.
Numerous attempts have been made to bring a NASH drug to the FDA finish line, but the path to approval is fraught with failures. Most recently, and devastatingly for the company, Intercept Pharmaceuticals faced a setback in this pursuit.
Intercept first nabbed an approval for its drug Ocaliva in 2016 for primary biliary cholangitis but has for years tried to get a second label in the more lucrative NASH space. The long journey to an FDA approval for the company ended this year after a second FDA rejection that led Intercept to ditch its NASH hopes and restructure.
This regulatory failure followed from a whole series of trial flops and setbacks in NASH over the past five years, including for Genfit, Novo Nordisk, Akero Therapeutics, Conatus/Novartis and many others, which all failed to make their therapies work well enough and safe enough in trials to warrant an approval.
A successful NASH drug could still prove to be a megablockbuster for any company if it can produce the right results and a strong launch.
Analysts have agreed that Madrigal’s once-daily oral thyroid hormone receptor is likely to be the first NASH treatment to make it to market, and Mizuho analysts have previously forecast that the biotech could see $1 billion in peak sales as the first in the indication.
But being first to market also has its drawbacks: Madrigal will need to beat the first path and convince patients and healthcare professionals about the need for this new drug as well as educate on diagnosis. This is where Huntsman’s experience will likely need to come into play.
“Carole Huntsman’s leadership skills and experience are a perfect fit for Madrigal as we prepare for a first-to-market launch of resmetirom in the U.S.,” said Sibold in a press release.
“She has an extensive track record of specialty launch success and excels in building and leading high-performing teams that deliver innovative new therapies to patients with serious diseases. I’m thrilled to welcome Carole to Madrigal and look forward to working with her as we continue to build a world-class commercial organization.”