ANN ARBOR — Esperion Therapeutics Inc. (Nasdaq:ESPR), the Ann Arbor-based pharmaceutical startup developing a new class of cholesterol-lowering drugs, announced the appointment of Jay P. Shepard as a Class III Director, with a term expiring at the 2019 annual meeting of stockholders.
“Jay’s experience supporting the launch and commercialization of biopharmaceutical products will be invaluable as we advance the bempedoic acid product franchise through the final stages of development and approval,” said Tim Mayleben, Esperion president and CEO. “With five pivotal Phase 3 studies reporting out this year, and a clear regulatory pathway forward, Esperion has entered the most significant period in our history. Given his breadth of knowledge in bringing new drugs to market, we are confident that Jay will make important contributions to help us deliver once-daily, oral therapies that complement existing standard-of-care treatments to the millions of patients in need of additional LDL-C lowering.”
Shepard has served as president and CEO of Versartis Inc. since May 2015, and has also served as executive chairman of the Versartis Board since early 2014. He also previously served as executive partner at Sofinnova Ventures, president and CEO of NextWave Pharmaceuticals, which was acquired by Pfizer, president and CEO of Ilypsa, which was acquired by Amgen, interim president and CEO of Ilypsa spinout Relypsa, which was acquired by Galencia, and vice president of commercial operations at Telik and Alza Pharmaceuticalsm, which was acquired by Johnson & Johnson.
Shepard has more than 30 years’ experience in the pharmaceutical, biotechnology and drug delivery arenas, and has participated in or led more than 16 product launches by preparing markets and establishing sales and marketing operations. Shepard is a board member of Versartis Inc., the Christopher & Dana Reeve Foundation, and the Santa Clara University Entrepreneurial School. He earned a Bachelor of Science in business administration from the University of Arizona.
Said Shepard: “I look forward to supporting the lipid management team as they develop commercialization plans for the bempedoic acid franchise with the goal to provide high-risk patients with hypercholesterolemia complementary, once-daily, oral therapies to lower elevated levels of LDL-C.”
Esperion is developing a novel product called bempedoic acid that inhibits cholesterol synthesis, and is combining it with a drug called ezetimibe that inhibits cholesterol absorption, to create a novel non-statin cholesterol reducting drug that can be delivered orally once a day. That’s particularly important for the millions of people who are intolerant of today’s cholesterol-lowering drugs, called statins, which cause muscle pain and weakness in some people. Bempedoic acid also reduces hsCRP, a key marker of inflammation associated with cardiovascular disease.
Completed Phase 1, Phase 2 and Phase 3 studies conducted in more than 4,100 patients, and more than 2,700 patients treated with bempedoic acid, have produced LDL-C lowering results of up to 30 percent as monotherapy, approximately 50 percent in combination with ezetimibe and an incremental 20-plus percent when added to stable statin therapy.
The effect of bempedoic acid on cardiovascular morbidity and mortality has not yet been determined. The company initiated a global cardiovascular outcomes trial (CVOT) to assess the effects of bempedoic acid on the occurrence of major cardiovascular events in patients with, or at high risk for, cardiovascular disease (CVD) who are only able to tolerate less than the lowest approved daily starting dose of a statin and considered “statin intolerant.” The CVOT — known as Cholesterol Lowering via Bempedoic Acid, an ACL-inhibiting Regimen (CLEAR) Outcomes — is an event-driven, global, randomized, double-blind, placebo-controlled study expected to enroll approximately 12,600 patients with hypercholesterolemia and high CVD risk at more than 600 sites in approximately 30 countries.
More at www.esperion.com.