ESPR Esperion Therapeutics Inc

Esperion Announces Publication of Results From Phase 2 Study of ETC-216 and Upcoming Conference Call ANN ARBOR, Michigan, November 4 /PRNewswire/ -- Study appearing in November 5, 2003 issue of Journal of the American Medical Association (JAMA) provides significant evidence of rapidly reduced atherosclerosis with investigational HDL therapy Esperion will host conference call on Tuesday, November 4, 2003, at 4:30 p.m. to discuss results. Esperion Therapeutics, Inc. (Nasdaq: ESPR) today announced the results of a study providing significant evidence that its investigational product candidate, ETC-216 (ApoA-I Milano/phospholipid complex or AIM), rapidly reduced the size of plaque in coronary arteries and reversed atherosclerosis. The results of the study appear in the November 5, 2003 issue of the Journal of the American Medical Association (JAMA). The study is the first clinical evidence that atherosclerosis, a progressive disease resulting from deposits of fatty substances such as cholesterol in the artery walls, can be rapidly reversed. "These results demonstrate for the first time that it is possible to rapidly regress the major underlying cause of heart attack," said Roger S. Newton, Ph.D., President and CEO of Esperion Therapeutics. "By enhancing the removal of cholesterol from plaques in artery walls, a process known as reverse lipid transport, HDL therapy may provide an innovative approach to the treatment of atherosclerosis. We are excited about these results and look forward to continuing the development of ETC-216 in more patients with longer follow-up and assessing more endpoints, including morbidity and mortality." In the Phase 2 clinical trial, 47 patients with acute coronary syndromes (ACS) received five weekly intravenous infusions of placebo (n=11 patients), ETC-216 at 15 mg/kg (n=21 patients) and ETC-216 at 45 mg/kg (n=15 patients). Plaque volume was measured before treatment and within two weeks after the final infusion using intravascular ultrasound (IVUS). With IVUS, a tiny ultrasound probe is inserted into the coronary artery to directly image and measure the size of the atherosclerotic plaques. The study revealed a statistically significant reduction (p=0.02) in percent atheroma (plaque) volume in the combined ETC-216 treatment groups comparing end-of-treatment values to baseline values. Additional IVUS endpoints in the trial, such as total atheroma volume and maximum atheroma thickness, also showed statistically significant improvements. "This study shows that ETC-216 could become an important new option for the treatment of people affected by atherosclerosis," said Steven E. Nissen, M.D., F.A.C.C., principal investigator of the study and medical director of the Cleveland Clinic Cardiovascular Coordinating Center. "We now have evidence that it is possible to rapidly and directly reverse the atherosclerotic disease process in artery walls." Of the 57 patients assigned to a treatment group, 47 patients completed the trial. Of the ten patients who did not complete the trial, two were withdrawn for an adverse event, three withdrew consent and five had IVUS studies that were not analyzable. Overall adverse event rates were similar in all three treatment groups and ETC-216 was generally well-tolerated. Cholesterol is transported in the bloodstream by special carriers called lipoproteins. Low density lipoprotein (LDL), often referred to as "bad" cholesterol, transports cholesterol to the body's cells. High levels of LDL- cholesterol can lead to the build-up of cholesterol and other fats in the walls of arteries. These deposits can eventually form a plaque. If a plaque ruptures and a clot forms and blocks an artery, it can cause a heart attack. High-density lipoprotein (HDL), often referred to as "good" cholesterol, is believed to remove cholesterol and other lipids from artery walls and other tissues and transport them to the liver where they are eliminated from the body. ApoA-I Milano is a variant of ApolipoproteinA-I (ApoA-I), the major protein component of HDL. ApoA-I Milano is present in a small population of northern Italians with paradoxically low levels of HDL-cholesterol. Low HDL- cholesterol levels normally would correlate with high risk for cardiovascular disease, but carriers of the ApoA-I Milano gene show a reduced risk, presumably due to enhanced reverse lipid transport (RLT), the body's process of removing excess cholesterol and other lipids from artery walls and other tissues and transporting them to the liver for elimination. ETC-216 (AIM) is a human recombinant version of ApoA-I Milano combined with a phospholipid to form a complex that imitates the structure and function of HDL. ETC-216 is designed to mimic the beneficial properties of HDL and enhance RLT. According to the American Heart Association, more than 60 million Americans have some form of cardiovascular disease. It is the leading cause of death in the United States, claiming the lives of nearly one million Americans each year. Esperion Will Host Conference Call on Tuesday, November 4, at 4:30 p.m. Esperion will hold a conference call at 4:30 p.m. (ET) on Tuesday, November 4, 2003 to discuss the results of the Phase 2 clinical study of ETC-216 (AIM). Investors and others are invited to join the call live via telephone or on the Internet. What: Esperion Conference Call to Discuss ETC-216 (AIM) Study Results When: Tuesday, November 4, at 4:30 p.m. (ET) Via Telephone: From U.S. and Canada, dial +1(800) 901-5226 From other locations, dial +1(617) 786-4513 All callers should use the conference ID "Esperion." Via Internet: Visit http://www.esperion.com , click on the Investor Relations link and then the Calendar link shortly before 4:30 p.m. (ET). A replay of the Esperion conference call will be available beginning at 8:00 p.m. (ET) on November 4, 2003, until 11:59 p.m. (ET) on November 11, 2003. To access the replay from the U.S. and Canada, dial (888) 286-8010 and enter passcode #92056812. From all other locations, dial (617) 801-6888 and enter passcode #92056812. To access the replay via the Internet, visit http://www.esperion.com , click on the Investor Relations link and then click on the Audio/Visual Archives link. Esperion Therapeutics Esperion Therapeutics, Inc. discovers and develops pharmaceutical products for the treatment of cardiovascular disease. Esperion intends to commercialize a novel class of drugs that focuses on a new treatment approach called "HDL Therapy," which is based on the Company's understanding of high- density lipoprotein, or HDL, function. HDL is the primary facilitator of the RLT pathway by which excess cholesterol and other lipids are removed from arteries and other tissues and are transported to the liver for elimination from the body. Esperion's goal is to develop drugs that exploit the beneficial functions of HDL within the RLT pathway. Esperion currently has four product candidates in clinical development. Esperion is listed on the Nasdaq National Market under the symbol "ESPR." For more information, visit http://www.esperion.com . Safe Harbor Statement The information contained in this press release includes "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are often identified by words such as "hope," "may," "believe," "anticipate," "plan," "expect," "require," "intend," "assume" and similar expressions. Forward-looking statements speak only as of the date of this press release, reflect management's current expectations, estimations and projections and involve certain factors, such as risks and uncertainties, that may cause actual results, performance or achievements to be far different from those suggested by the Company's forward-looking statements. These factors include, but are not limited to, risks associated with: the Company's ability to successfully execute its business strategies, including entering into strategic partnerships or other transactions; the progress and cost of development of the Company's product candidates; the extent and timing of market acceptance of new products developed by the Company or its competitors; the Company's dependence on third parties to conduct clinical trials for the Company's product candidates; the extent and timing of regulatory approval, as desired or required, for the Company's product candidates; the Company's dependence on licensing arrangements and strategic relationships with third parties; clinical trials; manufacturing; the Company's dependence on patents and proprietary rights; litigation, proceedings, investigations and other disruptions of management's time resulting from the acquisition of the Company's common stock by various persons associated with Scott Sacane; the procurement, maintenance, enforcement and defense of the Company's patents and proprietary rights; competitive conditions in the industry; business cycles affecting the markets in which any of the Company's future products may be sold; extraordinary events and transactions; seeking and consummating business acquisitions, including the diversion of management's attention to the assimilation of the operations and personnel of any acquired business; the timing and extent of the Company's financing needs and the Company's access to funding, including through the equity market, particularly in light of the impact on the market value of the Company's common stock of matters outside of the Company's control, such as trading activities by third parties; fluctuations in foreign exchange rates; and economic conditions generally or in various geographic areas. Because all of the foregoing factors are difficult to forecast, you should not place undue reliance on any forward-looking statement. More detailed information about some of these and other risk factors is set forth in the Company's filings with the Securities and Exchange Commission. The Company does not intend to update any of these factors or to publicly announce the results of any revisions to any of these forward-looking statements other than as required under the federal securities laws. Company Amy Cannon Contact: Manager, Corporate Communications Esperion Therapeutics, Inc. +1(734) 222-1801 acannon@esperion.com Media Jim Wetmore Contact: Berry & Company Public Relations +1(212) 253-8881 jwetmore@berrypr.com Web site: http://www.esperion.com DATASOURCE: Esperion Therapeutics Inc. CONTACT: Company Contact: Amy Cannon, Manager, Corporate Communications of Esperion Therapeutics, Inc., +1-734-222-1801, acannon@esperion.com ; Media Contact: Jim Wetmore of Berry & Company Public Relations, +1-212-253-8881, jwetmore@berrypr.com FCMN Contact: fthomas@esperion.com

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