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Esperion's Cholesterol Drugs Receive Approval in Europe

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Esperion Therapeutics (ESPR - Free Report) announced that the European Commission has approved Nilemdo and Nustendi as a treatment for elevated LDL-C (bad cholesterol) in patients with hypercholesterolemia or mixed dyslipidemia. Please note that while Nilemdo is bempedoic acid monotherapy tablet, Nustendi is a combination of bempedoic acid and Merck’s (MRK - Free Report) Zetia (ezetimibe).

Both the drugs are approved as an adjunct to diet and in combination with a statin in patients receiving maximum tolerated dose of a statin or without statin in statin-intolerant patients.

The approval to the drugs was expected as the Committee for Medicinal Products for Human Use of the European Medicines Agency had recommended their approval in January. Moreover, Nilemdo and Nustendi were approved by the FDA for a similar indication in February under the tradename of Nexletol and Nexlizet, respectively.

The company launched Nexletol in the United States in March. It plans to launch Nexlizet in July. Please note that Esperion has an agreement with Daiichi Sankyo Europe under which commercialization of Nilemdo and Nustendi will be done by Daiichi Sankyo. Esperion will receive $150 million upon first commercial sale of Nilemdo and another $150 million upon first commercial sale of Nustendi.

Esperion’s stock has declined 46.5% so far this year compared withthe industry’s 24.5% decrease.

 

The company has successfully completed four pivotal studies on bempedoic acid and a pivotal study on bempedoic acid/ ezetimibe combo.

Data from four phase III studies evaluating bempedoic acid monotherapy, presented previously, demonstrated that treatment with the therapy led to an additional 18% reduction in LDL-C over 31% LDL-C reduction in statin-treated patients on maximally tolerated statin.

Data from the phase III study evaluating bempedoic acid/Zetia combination pill showed that the regimen reduced bad cholesterol by 35% compared with 24% for Zetia (20mg) monotherapy, 20% for bempedoic acid and 3% for placebo in patients receiving maximally tolerated statins.

Moreover, the targeted indications represent a significant opportunity for the company. It is estimated that 78 million people in the United States have high levels of LDL-C, 73 million in Europe and 30 million in Japan.

Meanwhile, the company is conducting the CLEAR cardiovascular outcomes study and expects to conclude the same in the second half of 2020. The study is evaluating bempedoic acid for the occurrence of major cardiovascular events in statin-averse patients with or at high risk of cardiovascular disease.

Esperion’s candidates will face significant competition from PCSK9 inhibitors — Sanofi (SNY - Free Report) /Regeneron’s (REGN - Free Report) Praluent and Amgen’s Repatha — already marketed for similar indications.

Zacks Rank

Esperion currently has a Zacks Rank #2 (Buy).

You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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