- The market for cholesterol drugs is about to get a new entrant, as Esperion Therapeutics received U.S. approval on Friday to sell its pill bempedoic acid for a certain group of patients with too high levels of so-called "bad" cholesterol.
- Esperion will sell its drug under the brand name Nexletol for a price of about $10 per day, according to a company spokesperson. Analysts at Jefferies point to a recent survey of 50 cardiologists suggesting Nexletol could capture 20% to 25% of the market for drugs that reduce low-density lipoprotein cholesterol — which, by Jefferies' estimates, would equate to around $2 billion in annual sales.
- Nexletol faces competition, however. Amgen as well as partners Sanofi and Regeneron have tried lowering the list prices on their respective cholesterol medicines to make inroads with insurers. Swiss pharma giant Novartis also recently made a big bet on the space by acquiring The Medicines Co. and its RNA-targeting therapy inclisiran for nearly $10 billion.
With approval in hand, Esperion's test now becomes whether it can avoid the roadblocks fellow cholesterol drugmakers have run into once on the market.
For years, patients with high levels of "bad" cholesterol have been prescribed a type of enzyme-inhibiting, lipid-lowering pill known as statins. Some of the better known statins include AstraZeneca's Crestor and Pfizer's Lipitor, each of which brought in billions of dollars annually before losing patent protection.
Statins continue to hold a large piece of the cholesterol drug market even with newer and more potent options available. That's largely due to price — Amgen's Repatha and Sanofi and Regeneron's Praluent, which treat high cholesterol by blocking an ezyme called PCSK9, both received approval in 2015 but came with list prices of more than $14,000 a year.
Payers proved extremely resistant to these higher cost therapies, so much so that Amgen, Sanofi and Regeneron ultimately shaved the price tags on their respective drugs by nearly $9,000.
Esperion looks as though it's trying to avoid the same challenges in its pricing of Nexletol. According to the company, eligible patients with commercial insurance can get the drug at $10 per fill for up to a three-month supply. Esperion said Nexletol will become commercially available on March 30.
While price and convenience could work to Nexletol's advantage — the drug is taken orally rather than by injection, as are Repatha and Praluent — Esperion won't be able to tout a cardio-protective benefit for its pill. A large outcomes study testing Nexletol's effect on heart risk is ongoing, but won't read out results until 2022.
In addition to Friday's approval, Esperion is awaiting a second regulatory decision on a combination of Nexletol with Merck's cholesterol pill Zetia. The Food and Drug Administration set Feb. 26 as the deadline for that decision.
Michael Yee, an analyst at Jefferies, expects the combination to get FDA clearnace, and models sales of nearly $40 million in 2020 across Nexletol's two approvals. Yee has predicted the drug could fetch $2 billion to $3 billion yearly at its peak.
Esperion's share price, meanwhile, appears to be experiencing a selloff common of small drugmakers graduating from clinical-stage to commercial-stage. Shares were down almost 10% at market's close Friday, to trade at $61.76 apiece.
Nexletol was approved specifically as an adjunct treatment to diet and maximally tolerated statin therapy for adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease who require additional lowering of "bad" cholesterol.