Esperion Therapeutics, Inc. ESPR announced updates on a clinical development program as well as its regulatory plans for lead candidate, bempedoic acid (ETC-1002), for the treatment of patients with elevated low density lipoprotein cholesterol (LDL-C).
The program includes pivotal phase III efficacy and safety studies, and a planned global cardiovascular outcomes trial (CVOT) in patients with elevated LDL-C levels who are unable to tolerate statins (statin intolerance).
These studies are expected to be initiated in the fourth quarter of 2016. While the pivotal phase III efficacy studies will assess patients with elevated LDL-C levels, including statin intolerant patients, the CVOT will evaluate the candidate in statin intolerant patients who are at high risk of cardiovascular (CV) diseases.
Esperion stated that the planned efficacy studies and the ongoing long-term safety and tolerability study (1002-040) will support the submission of a marketing application for bempedoic acid in patients with elevated LDL-C, including statin-intolerant patients in the EU in 2019. In addition, the CVOT will support the submission of a regulatory application for risk reduction of CV diseases in statin-intolerant patients in the EU in 2022.
However, the FDA has not provided any clarity on a regulatory pathway for an LDL-C lowering indication in statin-intolerant patients. Esperion plans to submit a New Drug Application (NDA) in the U.S. for a CV risk reduction indication on the basis of the successful completion of the CVOT in 2022.
Meanwhile, Esperion provided an update on its financial outlook for 2016. Full-year net cash used in operating activities are expected in the range $65–$75 million (previous expectations: $80–$90 million). Cash and cash equivalents and investment securities are expected to be approximately $220 million (prior guidance: $200 million) at Dec 31, 2016.
We remind investors that the cholesterol management market is presently dominated by drugs such as Praluent, Repatha, Mevacor and Pravachol among others.
Esperion currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include ANI Pharmaceuticals, Inc. ANIP, Bristol-Myers Squibb Company BMY and Pfizer Inc. PFE, each sporting a Zacks Rank #1 (Strong Buy).
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