Funds will be used for the commercial launch of bempedoic acid in 2020.
Esperion Therapeutics is a startup committed to developing drugs that lower low‑density lipoprotein cholesterol (LDL-C) levels. Its lead candidate is bempedoic acid, a once-daily, non-statin oral therapy designed to primarily work in the liver to inhibit cholesterol biosynthesis. The company has completed phase I–III studies of the drug both for lowering elevated LDL-C levels and for lowering the risk of cardiovascular disease. Esperion has submitted New Drug Applications for bempedoic acid to the U.S. Food and Drug Administration and a Marketing Authorization Application to the European Medicines Agency.
The expectation is that Experion will be able to launch bempedoic acid in 2020. In advance of that launch, Esperion recently raised an additional $200 million from Oberland Capital, with $125 million provided immediately, $50 million to be delivered once FDA approval is obtained (PFUFA date of February 20, 2020) and the last $50 million to be made available when needed. The FDA has indicated that it will not require an expert panel to review the drug, which reduces the risk of rejection.
This money is in addition to $300 million paid by Daiichi Sankyo at the beginning of 2019 — in upfront and near-term milestones — for the European rights to bempedoic acid. According to company head Mayleben, the additional money was not needed to fund the commercial launch, but provides a buffer for its cash position.
Bempedoic acid will compete with both inexpensive generics that account for the majority of the market and more expensive PCSK9s, which have been deeply discounted in order to gain market share. Esperion’s drug lowers LDL-C levels at a rate between those of the two existing classes, so it could face severe competition.