Esperion Therapeutics Inc. (NASDAQ:ESPR)

[Michael Scally MD]

I think this might be an entry point for ESPR. It is down ~20%.
They are hit from the SNY/REGN panel yesterday.


ESPR -23% on yesterday’s SNY/REGN panel.

SNY/REGN—FDA panel backs Praluent with reservations in 13-3 vote:
http://www.wsj.com/articles/fda-panel-backs-cholesterol-drug-but-raises-concerns-1433884972

A Food and Drug Administration advisory panel recommended that the agency approve the cholesterol-lowering drug Praluent, the first of a wave of such cardiovascular drugs [PCSK9] expected to raise billions of dollars in revenue and perhaps alter the treatment of cardiovascular disease.

But many panelists said the use of the drug should be limited to certain high-risk groups, such as people with very high cholesterol for genetic reasons because of a condition called familial hypercholesterolemia.

The committee voted 13-3 in favor of Praluent, from France’s Sanofi and Regeneron Pharmaceuticals Inc. But enough panelists expressed caution about the evidence in the companies’ studies, and so it may take longer than the industry would like to get these medicines widely used.

Esperion Therapeutics Inc. (NASDAQ:ESPR)
http://www.esperion.com/
https://www.google.com/finance?q=NASDAQ:ESPR

ETC-1002
http://www.esperion.com/therapies-progress/etc-1002/

ETC-1002 is a novel, first-in-class, orally available, once-daily LDL-C lowering small molecule designed to lower levels of LDL-C and to avoid side effects associated with existing LDL-C lowering therapies.

ETC-1002 has a unique dual mechanism of action that has the potential to regulate both lipid and carbohydrate metabolism. ETC-1002 appears to work by inhibiting ATP citrate lyase (ACL), a key enzyme in the cholesterol biosynthetic pathway, and activating a complementary enzyme, 5′-adenosine monophosphate-activated protein kinase (AMPK). Both enzymes are known to play significant roles in the synthesis of cholesterol and glucose in the liver. By inhibiting cholesterol synthesis in the liver, ETC-1002 causes the liver to take up LDL particles from the blood, which reduces LDL-C levels.

 

[Michael Scally MD]

Esperion Announces U.S. FDA Acceptance of New Drug Applications (NDAs) for Both Bempedoic Acid and the Bempedoic Acid / Ezetimibe Combination Tablet for Filing and Regulatory Review
https://investor.esperion.com/news-releases/news-release-details/esperion-announces-us-fda-acceptance-new-drug-applications-ndas (Esperion Announces U.S. FDA Acceptance of New Drug Applications (NDAs) for Both Bempedoic Acid and the Bempedoic Acid / Ezetimibe Combination Tablet for Filing and Regulatory Review | Esperion Therapeutics, Inc.)

· Bempedoic Acid is an Oral, Once-daily ATP Citrate Lyase (ACL) Inhibitor that Reduces Cholesterol and Fatty Acid Synthesis in the Liver –
· February 21, 2020 PDUFA Target Date Goal for Bempedoic Acid and February 26, 2020 PDUFA Target Date Goal for the Bempedoic Acid / Ezetimibe Combination Tablet –
· The FDA also communicated there is no current plan to hold an advisory committee meeting to discuss the applications –

ANN ARBOR, Mich., May 05, 2019 (GLOBE NEWSWIRE) -- Esperion (Nasdaq: ESPR) announced today that the U.S. Food and Drug Administration (FDA) has accepted both New Drug Applications for bempedoic acid and the bempedoic acid / ezetimibe combination tablet for filing and regulatory review. Bempedoic acid and the bempedoic acid / ezetimibe combination tablet were developed to be complementary, cost-effective, convenient, once-daily, oral therapies for the treatment of patients with elevated low-density lipoprotein cholesterol (LDL-C) who need additional LDL-C lowering despite the use of currently accessible therapies.

The PDUFA (Prescription Drug User Fee Act) goal date for the completion of the bempedoic acid NDA review is set for February 21, 2020, and the PDUFA goal date for completion of the bempedoic acid / ezetimibe combination tablet NDA review is set for February 26, 2020. These dates are consistent with our expectations and reflect the standard review period. The FDA has communicated that there is no current plan to hold an advisory committee meeting to discuss the applications.

…

Bempedoic Acid

Bempedoic acid is our lead, non-statin, complementary, orally available, once-daily, LDL-C lowering therapy. With a targeted mechanism of action, bempedoic acid is a first-in-class, ATP Citrate Lyase (ACL) inhibitor that reduces cholesterol biosynthesis and lowers LDL-C by up-regulating the LDL receptor. Similar to statins, bempedoic acid also reduces hsCRP, a key marker of inflammation associated with cardiovascular disease.

Completed Phase 3 studies conducted in more than 4,000 patients, with over 2,600 patients treated with bempedoic acid, have produced an additional 18 percent LDL-C lowering when used with moderate- and high-intensity statins and 28 percent LDL-C lowering when used with no background statin.

Bempedoic Acid / Ezetimibe Combination Tablet

Through the complementary mechanisms of action of inhibition of cholesterol synthesis (bempedoic acid) and inhibition of cholesterol absorption (ezetimibe), the bempedoic acid / ezetimibe combination tablet is a non-statin, orally available, once-daily, LDL-C lowering therapy. Inhibition of ATP Citrate Lyase (ACL) by bempedoic acid reduces cholesterol biosynthesis and lowers LDL-C by up-regulating the LDL receptor.

Inhibition of Niemann-Pick C1-Like 1 (NPC1L1) by ezetimibe results in reduced absorption of cholesterol from the gastrointestinal tract, thereby reducing delivery of cholesterol to the liver, which in turn upregulates the LDL receptors.

Phase 3 data demonstrated that this combination results in a 29 percent LDL-C lowering when used with maximally tolerated statins, a 44 percent LDL-C lowering when used with no background statin (post-hoc analysis), and a 34 percent reduction in high sensitivity C-reactive protein (hsCRP).