ANN ARBOR—Esperion Therapeutics Inc. announced U.S. Food and Drug Administration approval of Nexlizet, a combination tablet of Esperion’s new non-staticholesterol reducing drug bempedoic acid and an earlier non-statin cholesterol-reducer, exetimibe.
The new drug will be an oral, once-daily, non-statin medicine designed to reduce levels of LDL cholesterol, the so-called bad cholesterol, intended for people who can’t tolerate or reach their cholesterol goals using today’s statin drugs.
“The approval of Nexlizet underscores Esperion’s commitment to providing patients and their healthcare providers with innovative non-statin medicines that fit into their everyday routines to lower elevated levels of bad cholesterol in adult patients with atherosclerotic cardiovascular disease or heterozygous familial hypercholesterolemia on maximally tolerated statins. This is the first non-statin combination medicine ever approved for lowering LDL-C,” said Tim Mayleben, president and CEO of Esperion. “We are truly grateful to all of the patients and healthcare providers who put their confidence in Esperion’s team of lipid experts.”
LDL-C is a waxy, fat-like substance that’s found in the body. Elevated LDL-C contributes to a buildup of this fat in the arteries and can lead to cardiovascular events including heart attack and stroke. Despite standard of care treatments, it is estimated nearly 15 million ASCVD or HeFH patients on maximally tolerated statins in the U.S. cannot achieve guideline recommended LDL-C levels.
The approval of Nexlizet is supported by several studies. It lowered LDL-C by a mean of 38 percent compared to placebo when added on to maximally tolerated statins. Results have been published in The European Journal of Preventative Cardiology.
Nexlizet was generally well-tolerated in a pivotal Phase 3 study. Label warnings and precautions include hyperuricemia, with the development of gout in a small percentage of patients, as well as an increased risk of tendon rupture or injury. For additional information on NEXLIZET, please see Full Prescribing Information at Esperion.com.
Esperion is working with health insurance providers to help ensure broad insurance coverage and patient access to its medicines. Eligible patients with commercial drug insurance coverage for our medicines may pay as little as $10 per fill, up to a 3-month supply. Nexlizet will be commercially available for U.S. patients in July 2020. Nexletol will be commercially available for U.S. patients on March 30.
The approvals mean Esperion will begin recording product revenue this year, but the company said it would not provide a prediction as to the amount. As of Dec. 31, Esperion had cash and equivalent on hand of $201.7 million, up from $136.3 million a year earlier.
Revenue was $1 million for the fourth quarter of 2019 and $148.4 million for the year ended Dec. 31, compared to zero for the comparable periods in 2018. Revenue was primarily attributable to the initial recognition of the upfront payment from the Daiichi Sankyo Europe collaboration agreement. Research and development expenses were $38.2 million for the fourth quarter and $175.6 million for the year, compared to $49.5 million and $171.5 million for the comparable periods in 2018. General and administrative expenses were $21.7 million for the fourth quarter of 2019 and $65.9 million for the year, compared to $11.2 million and $33.1 million for the comparable periods in 2018.
Esperion had a net loss of $61.9 million for the fourth quarter and $97.2 million for the year, compared to $60 million and $201.8 million for the comparable periods in 2018.
