Full Results from Esperion's Cholesterol Drug Fail to Impress Investors
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Esperion presented full results from the CLEAR outcomes study of its non-statin cholesterol lowering therapy Nexletol at the American College of Cardiology’s Annual Scientific Session & Expo on Saturday.
While the Michigan-based company celebrated the data as a win, investors were less impressed. Shares of Esperion dropped around 20% in pre-market trading Monday.
The results were also published in the New England Journal of Medicine.
Esperion has had mediocre success with Nexletol since its approval in 2020, along with Nexlizet, for adult patients with heterozygous familial hypercholesterolemia (HeFH) or established atherosclerotic cardiovascular disease. The pharma cut 40% of its workforce in October 2021 after the drug failed to thrive on the market.
On an investor call Monday, Sheldon Koenig, CEO, said that with the results from CLEAR, the company is now poised for a major inflection in sales and is targeting blockbuster status.
The trial, which enrolled 14,000 patients who have, or are at risk for, cardiovascular disease, intended to show what Nexletol could do by itself, without a statin.
While statins are, hands down, the most effective treatment for high cholesterol, anywhere between 5-to-30% of patients prescribed them are unwilling or unable to take them due to side effects like muscle pain and cramps.
“Less than half of the patients that have guideline indications for LDL lowering are actually being treated to goal and it's even worse than primary prevention,” said Dr. Steve Nissen, cardiologist at the Cleveland Clinic and principal investigator of the CLEAR outcomes study, during the press conference.
Patients in the trial experienced a reduced risk of major adverse cardiac events by 13% and 15%, respectively. The drug also reduced the risk of heart attack by 23% and coronary revascularization by 19%.
Esperion intends to file a request for label expansion to include cardiovascular risk reduction in the first half of 2023. The company this expansion could come in 2024, according to Monday’s press release.
A potential label expansion is expected to trigger up to $440 million in milestone payments from Esperion’s partner, Daiichi Sankyo.
Esperion’s U.S. product revenue for 2022 was $56 million.
Nexletol’s biggest competitor is injectable PCSK9s. Amgen’s Repatha posted $1.296 B in 2022 sales. Studies of Repatha showed a 15% reduction in cardiovascular events compared to Nexletol’s 13%. Although it is important to note that Repatha was given on top of statins in the study.
Bempedoic acid, the main ingredient in Nexletol and combination ingredient in Nexlizet is activated in only the liver to reduce the statin-associated adverse events and cause fewer drug interactions.
Esperion will scale up its 65-70 head sales force in preparation for anticipated growth.