Published: November 15, 2021, by Mark Terry

As a class of drugs for the treatment of high cholesterol, PCSK9 inhibitors are difficult to track in the market. Designed to treat patients with high cholesterol who do not respond to statins. Since around 2015, many companies have obtained approval for these drugs, but have encountered difficulties in sales. They include Amgen's Repatha, Sanofi and Regeneron's Praluent, Novartis' Leqvio, and Esperion's Nexletol and Nexlizet.

One of the problems is price. For example, Repatha and Praluent's annual supply prices are both around $14,000, even though the two companies cut costs to $5,850 each year. Since the price of statins is usually around US$50 per month, payers have been reluctant to pay for these drugs, which are designed for patients with extremely high, largely untreated cases of hereditary diseases leading to high cholesterol use.

Esperion, based in Ann Arbor, Michigan, has been working hard to launch its drug, and the timing is of no avail-they are trying to launch it at the height of the COVID-19 pandemic. In October 2021, the company announced plans to lay off 40% of its workforce and reduce operating expenses in the 2021 and 2022 fiscal years. They hope to save at least US$80 million through these measures.

At the time, Sheldon Koenix, President and CEO of Esperion, said: “Cardiovascular disease is still the number one cause of death in the world. Esperion is fortunate to have two popular first-class drugs approved and listed, giving us the opportunity to become a cardiovascular market. Leaders. Today’s decision will help the further development of Nexletol and Nexliet, while saving resources to support our critically differentiated CLEAR Outcomes trial, which we believe has the potential to significantly increase the adoption of our innovative cholesterol-lowering drugs ."

Now, Merck is presenting data on its PCSK9 inhibitor MK-0616 at the American Heart Association meeting. If Merck can push the drug to the finish line, all drugs in this category may face challenges, which are still only in phase I trials. But in the study, Merck's drug lowered low-density lipoprotein cholesterol by about 65%. Nexletol alone can reduce cholesterol by 15-25%, and when combined with Nexlizet, it can reduce cholesterol by approximately 38%. Repatha reduces LDL by about 55%, Praluent by about 58%, and Leqvio by 50-52%.

Dr. Douglas Johns, clinical director of Merck, who provided the data, said: "The initial results are encouraging; however, given the limited clinical experience of the MK-0616 molecule, more clinical studies are needed to confirm these findings."

Johns was asked about the potential price of MK-0616, but he said that it is too early to discuss, but the company is considering this "very seriously".

On the AHA, Novartis also showed more post-event data on its Leqvio. In November 2019, Novartis acquired The Medicines Company for $9.7 billion and Leqvio. Analysts believe that Novartis expects annual sales of the drug to exceed $2 billion, but because The Medicines Company acquired the drug from Alnylam, profits were divided. Compared with Repatha and Praluent, Leqvio's hypothetical advantage is that these drugs are administered every two weeks or monthly, while Leqvio can be administered twice a year.

However, in December 2020, the FDA issued a complete response letter (CRL) to Novartis due to “the situation related to the facility inspection has not been resolved”. In July 2021, Novartis announced that it had resubmitted a New Drug Application (NDA). Its target date of action with the FDA is January 1, 2022. The drug has been approved in Europe.

In addition to higher efficacy, Merck's MK-0616 can also be taken orally.

In the second quarter of 2021, Amgen announced that Repatha's sales in the quarter increased by 43% year-on-year, driven by 49% sales growth. Sales for the quarter were $286 million. Regeneron reports that Praluent’s sales in the second quarter of 2021 were $99.4 million.

Esperion's only products are Nexletol and Nexlizet. In their third-quarter financial report released on November 2, the total revenue for the quarter was 14.409 million U.S. dollars, and the total revenue so far this year was 63.046 U.S. dollars. For the nine months ended September 30, 2021, net product revenue for the quarter was US$10.9 million and US$27.9 million.

Novartis has stated that Leqvio is one of its growth drivers, but has not announced its European sales in its 2021 quarterly report.

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