Esperion Therapeutics (ESPR) stock recovered Monday from last week's Amgen (AMGN)-induced pitfall to touch an 18-month high after Esperion outlined its path to FDA approval for its cholesterol-busting drug, bempedoic acid.
Shares of The Medicines Co. (MDCO) also got a jump-start Monday after it and partner Alnylam Pharmaceuticals (ALNY) reported strong results for cholesterol-drug, Inclisiran, in a midstage trial.
On the stock market today, Esperion shot up 74.1% to 41.20. The Medicines Co. stock lifted 6% to 51.26. Amgen stock edged up 0.35% to 169.21, on a price target cut.
Esperion said Monday it's seeking to have bempedoic acid approved to lower "bad" LDL cholesterol and to reduce the risk of cardiovascular disease. The proposed label would allow bempedoic acid to be used as an adjunct to statin therapy.
The FDA said an ongoing phase three trial in patients with elevated "bad" LDL cholesterol would be sufficient for approval. Esperion is also planning to look at the cardiovascular benefits of bempedoic acid in reducing heart disease in patients intolerant to statins.
Defining Statins
On Monday, the FDA and Esperion settled on a definition of statin intolerance as "the inability to tolerate two or more statins, one at the lowest approved daily dose, due to an adverse effect."
For those patients, Esperion hopes to have bempedoic acid approved as an adjunct therapy. The biotech plans to enroll 12,600 patients with hypercholesterolemia and a high risk of cardiovascular disease in the cardiovascular outcomes trial.
The biotech expects to report top-line safety and tolerability data by the second quarter of 2018 and have efficacy data by mid-2018. Esperion expects to file applications for bempedoic acid in the U.S. and Europe in the first half of 2019.
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Late Friday, The Medicines Co.and Alnylam Pharmaceuticals said Inclisiran cut "bad" LDL cholesterol by an average 52.6% and by up to 81% at day 180 at the optimal starting dose regimen.
Inclisiran was well tolerated with no material safety issues in the 497-patient trial, The Medicines Co. said in a news release. Inclisiran belongs to a class of drugs called PCSK9 inhibitors.
PCSK9 inhibitors work by blocking the interaction between the PCSK9 protein and the LDL receptor. Doing so, cuts down on the "bad" LDL cholesterol in the blood. Drugs from Amgen and Regeneron (REGN)/Sanofi (SNY) have a similar mechanism.
Shares of Alnylam, which is partnered with The Medicines Co. on Inclisiran, were up 8.1% to 59.71.
Amgen Price Target Cut
No. 1 biotech Amgen saw more fallout Monday from its disappointing Fourier results early Friday. Investment bank Goldman Sachs cut its price target on Amgen stock to 202 from 208 on lower estimates for cholesterol-drug Repatha. The bank kept its buy rating on Amgen stock.
Following Fourier, Amgen said it plans to offer innovative contracts with pharmacy benefit managers and payers. The goal is to expand insurance coverage of Repatha for the cardiovascular benefit, not just to lower "bad" LDL cholesterol.
There were some positive points in the data that Amgen presented Friday, Goldman Sachs analyst Terrence Flynn said. Then, Amgen said Repatha cut down on major adverse cardiovascular events by 15%. But analysts broadly expected 20% or better, he said.
"Some investors have pointed to the lack of benefit on cardiovascular death," he said. "But physician feedback suggests this was not a realistic expectation as the trial was not powered to demonstrate this and it took statins a long time to demonstrate a benefit here."
Amgen's results sent shares of Esperion and The Medicines Co. into a tailspin Friday. Shares of Esperion closed down 24.9% with The Medicines Co. stock losing 8.4%. Amgen stock closed down 7.1%.
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