Following the US Food and Drug Administration’s (FDA) acceptance of Madrigal Pharmaceuticals’ new drug application and priority review for its thyroid hormone receptor-beta agonist resmetirom in nonalcoholic steatohepatitis (NASH), the company has started to restructure its leadership team in preparation for the drug’s anticipated launch in the second quarter of 2024.
In September this year, Madrigal appointed Bill Sibold as the new CEO and a member of the board of directors (BOD), replacing Paul Friedman MD, who has been serving as CEO since 2016.
Friedman will remain on the BOD. Before joining Madrigal, Sibold held the position of executive vice-president of speciality care at Sanofi, served as president of Sanofi North America, and was a valued member of the Sanofi Executive Committee.
Earlier this month, Madrigal welcomed Carole Huntsman, another Sanofi alum, as its new CCO.
Huntsman previously held various leadership positions at Sanofi, including senior vice-president, head of speciality care North America, and US country lead.
Both Sibold and Huntsman played a key role in the successful launch of Dupixent, a blockbuster immunology drug co-marketed by Sanofi and Regeneron.
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Madrigal has made the above changes to its senior management team to maximise its commercial strategy for resmetirom.
In addition to these leadership changes, Madrigal has also been engaged in a series of financing rounds to support resmetirom through the remaining clinical stages and into the planned commercial activities.
In December 2022, the company announced that it had raised $259m in equity securities sales and $50m in additional debt financing capacity in a Series B financing round.
The financing round occurred shortly after the company had announced positive topline data from its pivotal Phase III MAESTRO-NASH clinical trial of resmetirom (NCT03900429), which demonstrated that resmetirom achieved a reduction in the NASH activity score and lowered the level of low-density lipoprotein cholesterol, both of which are clinical endpoints that the FDA has associated with predicting clinical benefit.
In late September 2023, Madrigal raised $500m following a public offering of 1.2 million shares of its common stock and prefunded warrants of two million shares of common stock at a price of $151.69 per share/prefunded warrant.
Despite these last two financing rounds, it remains to be seen how Madrigal intends to handle the launch of resmetirom, as $759m ($259m + $500m) is not nearly enough funding to launch a new drug into the market.
For context, Deloitte, a business services consultancy, reported that the average cost of developing a new drug among the top 20 global pharmaceutical companies in 2022 was $2.3bn.
Nonetheless, there is still time for Madrigal to raise more funds, as the FDA has assigned resmetirom a Prescription Drug User Fee Act date of 14 March 2024.
Still, there has been speculation that Madrigal is positioning itself to procure a partnership with a more established pharmaceutical company or as an acquisition target prior to the launch of resmetirom.
Despite these preparations, it remains to be seen how Madrigal will handle the launch of resmetirom in NASH, as it is anticipated to be the first drug to be marketed for NASH in the US.
Despite positive clinical results, the commercialisation of resmetirom may still prove to be a tough battle, particularly for a clinical-stage biopharmaceutical company.
According to a 2021 analysis by McKinsey & Company, a prominent management consultant, although the share of first-time launchers (small biopharmaceutical companies) has more than tripled over the past ten years, these companies also have a harder time achieving their sales forecasts.
However, changes in Madrigal’s leadership seem to be steps taken in the right direction to maximise the large commercial opportunity in NASH.
With a potential first-to-market therapy for NASH, Madrigal will have to navigate the difficulties of high development costs and educate patients, healthcare professionals, and payers about resmetirom and its role in NASH.
While the expertise of the Sanofi alum from Dupixent’s commercialisation team will be crucial for this part of the product life cycle, there is also a possibility that the company may position itself as an attractive stakeholder to partner within NASH, adding to a list of reasons to watch this space with anticipation and excitement.