ANN ARBOR, Mich., Dec. 14, 2017 (GLOBE NEWSWIRE) -- Esperion Therapeutics, Inc. (NASDAQ: ESPR ), the Lipid Management Company focused on developing and commercializing convenient, complementary, cost-effective, once-daily, oral therapies for the treatment of patients with elevated low density lipoprotein cholesterol (LDL-C), today announced the appointment of Jeffrey Berkowitz, J.D. as a Class II Director, with a term expiring at the 2018 annual meeting of stockholders.
“On behalf of the Lipid Management Team and our directors, it is with great pleasure that we welcome Jeff to the Esperion board. We look forward to applying insights from Jeff’s experience and expertise in the pharmaceutical industry and within the payer and PBM community as we advance the bempedoic acid product franchise through the final stages of development and approval,” said Tim Mayleben, president and chief executive officer of Esperion Therapeutics. “With five pivotal Phase 3 studies reporting out next year, Esperion is entering the most transformative and exciting period in our history. We are confident Jeff will provide important contributions to help us deliver on the promise of bringing our complementary, oral LDL-C lowering therapies to the millions of patients who are inadequately treated with, or unable to gain access to, current LDL-C lowering therapies.”
Mr. Berkowitz is the former executive vice president of Optum, Inc., a health services platform business of UnitedHealth Group, Inc. Previously, he was executive vice president and president of Pharma and Global Market Access with Walgreens Boots Alliance, Inc., a global pharmacy-led, health and well-being enterprise, where he was responsible for generic and branded procurement, specialty pharmacy, inventory management and oversaw relationships with pharmaceutical companies as well as pricing and reimbursement strategies with all payer segments. Additional experience includes serving as president of Walgreens Boots Alliance Development, GmbH, a joint venture between Walgreens Co. and Alliance Boots located in Switzerland; and having held a variety of senior executive positions with increasing responsibility in market access, sales and marketing with Merck and Schering-Plough as well as serving as healthcare attorney with Proskauer, LLP. Mr. Berkowitz earned his B.A. in political science from Union College in Schenectady, N.Y., and his J.D. from Brooklyn Law School in Brooklyn, N.Y.
“I am delighted to be joining Esperion’s accomplished board of directors,” said Mr. Berkowitz. “I’m energized by the opportunity to offer guidance and support to the Lipid Management Team as they develop market access plans for the bempedoic acid-based franchise with the goal to provide high-risk patients with hypercholesterolemia complementary, once-daily, oral therapies to lower elevated levels of LDL-C.”
Bempedoic Acid / Ezetimibe Combination Pill
Through the complementary mechanisms of action of inhibition of cholesterol synthesis (bempedoic acid) and inhibition of cholesterol absorption (ezetimibe), the bempedoic acid / ezetimibe combination pill is our lead, 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 LDL receptors. Previously completed Phase 2 data demonstrated that this safe and well tolerated combination results in a 48 percent lowering of LDL-C, a 26 percent reduction in high sensitivity C-reactive protein (hsCRP), and may potentially be associated with a lower occurrence of muscle-related side effects.
Bempedoic Acid
With a targeted mechanism of action, bempedoic acid is a first-in-class, complementary, orally available, once-daily ACL inhibitor that reduces cholesterol biosynthesis and lowers LDL-C by up-regulating the LDL receptor, and may potentially be associated with a lower occurrence of muscle-related side effects. Completed Phase 1 and 2 studies conducted in approximately 1,300 patients, and over 800 patients treated with bempedoic acid, have produced clinically relevant LDL-C lowering results of up to 30 percent as monotherapy and an incremental 20+ percent when added to stable statin therapy.
Esperion's Commitment to Patients with Hypercholesterolemia
In the United States, 78 million people, or more than 20 percent of the population, have elevated LDL-C; an additional 73 million people in Europe and 30 million people in Japan also live with elevated LDL-C. Esperion's mission as the Lipid Management Company is to provide patients and physicians with convenient, complementary, cost-effective, once-daily, oral therapies to significantly reduce elevated levels of LDL-C in high-risk patients with hypercholesterolemia, including patients inadequately treated with current lipid-modifying therapies. It is estimated that 40 million patients with hypercholesterolemia in the U.S. are taking statins, approximately 12 million of those patients are at high-risk with atherosclerotic cardiovascular disease (ASCVD) and/or heterozygous familial hypercholesterolemia (HeFH) and with LDL-C that is not adequately controlled despite receiving maximally tolerated lipid-modifying background therapy. The 12 million high-risk patients include patients only able to tolerate less than the lowest approved daily starting dose of their statin and are considered statin intolerant. Esperion-discovered and developed, bempedoic acid is a targeted LDL-C lowering therapy in Phase 3 development. The company has two bempedoic acid-based LDL-C lowering therapies in Phase 3 development: 1) a once-daily, oral bempedoic acid / ezetimibe combination pill, and 2) bempedoic acid, a once-daily, oral pill.
The Lipid Management Company
Esperion Therapeutics, Inc. is the Lipid Management Company passionately committed to developing and commercializing convenient, complementary, cost-effective, once-daily, oral therapies for the treatment of patients with elevated LDL-C. Through scientific and clinical excellence, and a deep understanding of cholesterol biology, the experienced lipid management team at Esperion is committed to developing new LDL-C lowering therapies that will make a substantial impact on reducing global cardiovascular disease; the leading cause of death around the world. Bempedoic acid and the company's lead product candidate, the bempedoic acid / ezetimibe combination pill, are targeted therapies that have been shown to significantly reduce elevated LDL-C levels in patients with hypercholesterolemia, including patients inadequately treated with current lipid-modifying therapies. For more information, please visit www.esperion.com and follow us on Twitter at https://twitter.com/EsperionInc .
Forward-Looking Statements
This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding the regulatory approval pathway for the bempedoic acid / ezetimibe combination pill and bempedoic acid and the therapeutic potential of, clinical development plan for, the bempedoic acid / ezetimibe combination pill and bempedoic acid, including Esperion’s timing, designs, plans and announcement of results regarding the pivotal Phase 3 study (1002FDC-053) and the global pivotal Phase 3 clinical development program for bempedoic acid. Any express or implied statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Forward-looking statements involve risks and uncertainties that could cause Esperion's actual results to differ significantly from those projected, including, without limitation, the risks detailed in Esperion's filings with the Securities and Exchange Commission. Esperion disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release, other than to the extent required by law.
Media Contact: Elliot Fox W2O Group 212.257.6724 efox@w2ogroup.com
Investor Contact: Mindy Lowe Esperion Therapeutics, Inc. 734.887.3903 mlowe@esperion.com
