ESPR Esperion Therapeutics Inc.

37.24
+5.94  (+19%)
Previous Close 31.3
Open 31.41
52 Week Low 23.9
52 Week High 76.98
Market Cap $963,645,552
Shares 25,876,626
Float 21,968,959
Enterprise Value $536,234,828
Volume 3,426,122
Av. Daily Volume 742,310
Stock charts supplied by TradingView

Upcoming Catalysts

Drug Stage Catalyst Date
Bempedoic Acid (ETC-1002) CLEAR Outcomes
Cardiovascular Diseases
Phase 3
Phase 3
Premium membership is required to view catalyst dates, analyst ratings, earnings dates and cash burn data. Click here to unlock and sign up to a 14-day FREE TRIAL.

Drug Pipeline

Drug Stage Notes
Bempedoic Acid/ Ezetimibe
Hypercholesterolemia
Approved
Approved
FDA approval announced February 26, 2020.
Bempedoic acid
Hypercholesterolemia
Approved
Approved
FDA Approval announced February 21, 2020.
Bempedoic Acid/ Ezetimibe (1002-058)
LDL-C and type 2 diabetes
Phase 2
Phase 2
Phase 2 trial met primary endpoint - August 29, 2019.

Latest News

  1. – Fourth-quarter 2020 U.S. net product revenue estimated between $8.0 and $8.5 million –

    – Range represents over 140 percent sequential growth for NEXLETOL® (bempedoic acid) tablets and NEXLIZET® (bempedoic acid and ezetimibe) tablets –

    – Company provides full-year 2021 operating expense guidance –

    – In-licensed oral PCSK9 inhibitor program furthers ESPERION mission; leverages singular focus on oral, LDL-C lowering medicines –  

    ANN ARBOR, Mich., Jan. 13, 2021 (GLOBE NEWSWIRE) -- Esperion (NASDAQ:ESPR) today announced preliminary, unaudited fourth-quarter 2020 financial results and full-year 2021 operating expense guidance. Concurrently, the Company announced that it has entered into a definitive agreement with Serometrix to in-license…

    – Fourth-quarter 2020 U.S. net product revenue estimated between $8.0 and $8.5 million –

    – Range represents over 140 percent sequential growth for NEXLETOL® (bempedoic acid) tablets and NEXLIZET® (bempedoic acid and ezetimibe) tablets –

    – Company provides full-year 2021 operating expense guidance –

    – In-licensed oral PCSK9 inhibitor program furthers ESPERION mission; leverages singular focus on oral, LDL-C lowering medicines –  

    ANN ARBOR, Mich., Jan. 13, 2021 (GLOBE NEWSWIRE) -- Esperion (NASDAQ:ESPR) today announced preliminary, unaudited fourth-quarter 2020 financial results and full-year 2021 operating expense guidance. Concurrently, the Company announced that it has entered into a definitive agreement with Serometrix to in-license its oral, small molecule PCSK9 inhibitor program.

    "As a result of our company's exceptional focus and hard-fought performance, we enter the new year with a strong foundation and are building momentum toward our purpose of lipid management for everybody," said Tim M. Mayleben, president and chief executive officer of Esperion. "During 2020, despite the effects of the COVID-19 pandemic, Esperion took a huge step forward to provide physicians and patients easy and effective non-statin medicines to lower bad cholesterol, including the first-ever, fully non-statin fixed combination drug product, NEXLIZET®. I am excited to reinforce our commitment to patients with the addition of our oral PCSK9 inhibitor program, which has the potential to expand oral, non-statin treatment options even further."

    The small molecule PCSK9 inhibitor program is intended for development of a convenient, oral medicine. Patients and healthcare professionals favor oral medicines for ease of administration and compliance,1 but currently approved PCSK9 inhibitors are biologics delivered by subcutaneous injection, which, for many patients, are out of reach or may not be preferred.2,3 An oral PCSK9 inhibitor has the potential to provide an additional non-statin treatment option between statins and injectable PCSK9 inhibitors. There are currently no oral PCSK9 inhibitors available to patients.

    PCSK9 (proprotein convertase subtilisin/kexin type 9) is a protein responsible for regulating LDL receptor expression. Medicines that inhibit PCSK9 stop LDL receptors from being broken down, thus increasing the amount of LDL receptors and leading to removal of LDL-C from the blood. Inhibition of PCSK9 by injectable products has been clinically proven to reduce LDL-C and major cardiovascular events, as demonstrated by two completed cardiovascular outcomes trials (CVOTs) involving more than 46,000 patients.4,5

    "Esperion's new program targets allosteric inhibition of PCSK9, making our approach mechanistically different from earlier attempts to develop oral PCSK9 inhibitors," said Ashley Hall, chief development officer of Esperion. "The initial biophysical and cell-based data, as well as initial pharmacokinetic and efficacy data in preclinical models, indicate a high potential for a compelling drug profile. In addition to development as a monotherapy, we plan to pursue a fixed combination drug product with bempedoic acid in parallel. Clinical research has shown that bempedoic acid added to an injectable biologic PCSK9 inhibitor resulted in a mean additional ~30 percent LDL-C lowering compared to placebo.6 Together, this could be a compelling non-statin combination tablet for patients in need of further LDL cholesterol lowering and could provide health care providers and patients a broader range of oral options."

    Serometrix developed the oral PCSK9 inhibitor program with its proprietary technology to discover drugs for difficult protein targets. As part of the agreement, Esperion made an upfront cash payment of $12.5 million in December to Serometrix, with payments in future years tied to specific milestones. The Company anticipates sharing more information later this year on the potential timing for an Investigational New Drug (IND) application.

    "Serometrix has developed a proprietary platform focused on targeting protein conformational dynamics. This capability enabled our allosteric small molecule PCSK9 inhibitor program and allowed Serometrix to be the first to discover and patent allosteric small molecule inhibitors for PCSK9," said Kyle Monroe, chief executive officer of Serometrix. "We believe Esperion's commitment to hyperlipidemia, combined with their track record in development, make them an ideal strategic partner to advance this program through clinical development and beyond."

    Preliminary Fourth-Quarter 2020 Net Product Sales Results and Preliminary Full-Year 2021 Operating Expense Guidance

    Preliminary, unaudited fourth-quarter 2020 net U.S. product sales are expected to be between $8.0 and $8.5 million.

    As of December 31, 2020, cash, cash equivalents, and investment securities available-for-sale totaled approximately $305 million and there were approximately 25.9 million shares of common stock outstanding which excludes the 2.0 million treasury shares purchased in the prepaid forward transaction as part of the convertible debt financing.

    The Company expects full-year 2021 operating expenses to be approximately $320 million to $340 million, inclusive of $30 million of non-cash stock-based compensation.

    The preliminary unaudited results described in this press release are estimates only and are subject to revision until the Company reports its full financial results for the fourth quarter and full year 2020 in late February.

    39th Annual J.P. Morgan Healthcare Conference

    The Company will present at the virtual 39th Annual J.P. Morgan Healthcare Conference today, Wednesday, January 13, 2021, at 7:30 a.m. Eastern Time. A live audio webcast of this event can be accessed on the investor relations section of the Esperion website at investor.esperion.com. A replay of the webcast will be archived on the Company's website for 90 days following the event.

    Esperion Therapeutics

    Esperion is The Lipid Management Company. Our team of lipid experts works to lower bad cholesterol by discovering, developing and commercializing innovative medicines and combinations with established medicines. We work hard to make our medicines easy to take, easy to get and easy to have. We are singularly focused on disrupting high cholesterol so you can improve your health – easily. For more information, please visit www.esperion.com and follow us on Twitter at www.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 development of the oral PCSK9 inhibitor program and prospects for its successful development, potential commercialization plans for bempedoic acid tablet and Esperion's projected cash and non-cash operating expenses. 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, delays or failures in Esperion's clinical development and commercialization plans, or approval of expanded indications, that existing cash resources may be used more quickly than anticipated, the impact of COVID-19 on our business, clinical activities and commercial development plans, and the risks detailed in Esperion's filings with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and 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.

    References

    1 Dibonaventura MD, Wagner JS, Girman CJ, Brodovicz K, Zhang Q, Qiu Y, Pentakota,SR, & Radican L (2010). Multinational Internet-based survey of patient preference for newer oral or injectable Type 2 diabetes medication. Patient preference and adherence, 4, 397–406. https://doi.org/10.2147/PPA.S14477

    2 Baum SJ, Toth PP, Underberg JA, Jellinger P, Ross J, Wilemon K (2017). "PCSK9 inhibitor access barriers-issues and recommendations: Improving the access process for patients, clinicians and payers". Clinical Cardiology. 40 (4): 243–254. doi:10.1002/clc.22713. PMC 5412679. PMID 28328015.

    3 Gina Kolata, "These Cholesterol-Reducers May Save Lives. So Why Aren't Heart Patients Getting Them?", The New York Times, Oct. 2, 2018. Retrieved 18 December 2020.

    4 Sabatine MS, Giugliano RP, Keech AC, Honarpour N, Wiviott SD, Murphy SA, Kuder JF, Wang H, Liu T, Wasserman SM, Sever PS, and Pedersen TR (2017). Evolocumab and Clinical Outcomes in Patients with Cardiovascular Disease. N Engl J Med 2017; 376:1713-1722. DOI: 10.1056/NEJMoa1615664.

    5 Schwartz GG, Steg PG, Szarek M, Bhatt DL, Bittner VA, Diaz R, Edelberg JM, Goodman SG, Hanotin C, Harrington RA, Jukema JW, Lecorps G, et al (2018). Alirocumab and Cardiovascular Outcomes after Acute Coronary Syndrome. N Engl J Med 2018; 379:2097-2107. DOI: 10.1056/NEJMoa1801174

    6 https://www.globenewswire.com/news-release/2018/03/27/1453515/0/en/Esperion-Announces-Positive-Top-Line-Results-from-Phase-2-Study-of-Bempedoic-Acid-Added-On-to-a-PCSK9-Inhibitor-in-Patients-with-Hypercholesterolemia.html

    Contact:

    Kaitlyn Brosco

    ESPERION



    Primary Logo

    View Full Article Hide Full Article
  2. ANN ARBOR, Mich., Dec. 21, 2020 (GLOBE NEWSWIRE) -- Esperion (NASDAQ:ESPR), today announced that President and Chief Executive Officer, Tim M. Mayleben, will present at the virtual 39th Annual J.P. Morgan Healthcare Conference on Wednesday, January 13, 2021 at 7:30 a.m. Eastern Time.         

    Event:39th Annual J.P. Morgan Healthcare Conference
    Date: January 13, 2021
    Format:Virtual presentation & 1:1 Investor meetings
    Time:7:30 a.m. ET

    A live audio webcast of the virtual conference presentation can be accessed on the investor relations section of the Esperion website at www.esperion.com/investors-media/events-presentations/. Replay of the webcasts will be archived on the Company's website for 90 days following the events.

    Esperion Therapeutics

    ANN ARBOR, Mich., Dec. 21, 2020 (GLOBE NEWSWIRE) -- Esperion (NASDAQ:ESPR), today announced that President and Chief Executive Officer, Tim M. Mayleben, will present at the virtual 39th Annual J.P. Morgan Healthcare Conference on Wednesday, January 13, 2021 at 7:30 a.m. Eastern Time.         

    Event:39th Annual J.P. Morgan Healthcare Conference
    Date: January 13, 2021
    Format:Virtual presentation & 1:1 Investor meetings
    Time:7:30 a.m. ET

    A live audio webcast of the virtual conference presentation can be accessed on the investor relations section of the Esperion website at www.esperion.com/investors-media/events-presentations/. Replay of the webcasts will be archived on the Company's website for 90 days following the events.

    Esperion Therapeutics

    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 medicines that will make a substantial impact on reducing global cardiovascular disease, the leading cause of death around the world. For more information, please visit www.esperion.com and follow us on Twitter at www.twitter.com/EsperionInc.

    Esperion Therapeutics' Commitment to Patients with Hyperlipidemia

    High levels of LDL-C can lead to a build-up of fat and cholesterol in and on artery walls (known as atherosclerosis), potentially leading to cardiovascular events, including heart attack and stroke. In the U.S., 96 million people, or more than 37 percent of the adult population, have elevated LDL-C. There are approximately 18 million people in the U.S. living with elevated levels of LDL-C despite taking maximally tolerated lipid-modifying therapy — including individuals considered statin averse — leaving them at high risk for cardiovascular events1. In the United States, more than 50 percent of atherosclerotic cardiovascular disease (ASCVD) patients and heterozygous familial hypercholesterolemia (HeFH) patients who are not able to reach their guideline recommended LDL-C levels with statins alone need less than a 40 percent reduction to reach their LDL-C threshold goal2.

    Esperion's mission as the Lipid Management Company is to deliver oral, once-daily medicines that complement existing oral drugs to provide the additional LDL-C lowering that these patients need.

    References

    (1)  Esperion market research on file: research project interviewing 350 physicians. Esperion Therapeutics, Inc. Sept-Oct 2018.

    (2)  Data on file: analysis of NHANES database. Esperion Therapeutics, Inc. 2018.

    Investor Contact:

    Kaitlyn Brosco

    Esperion



    Primary Logo

    View Full Article Hide Full Article
  3. - NILEMDO® (bempedoic acid) is the first oral, once-daily treatment approved in almost two decades to lower low-density lipoprotein cholesterol (LDL-C) for indicated patients -

    - Bempedoic acid and its fixed combination drug product with ezetimibe both deliver significant reductions in LDL-C when added to a statin or other lipid-lowering therapies1,2 -

    - Two-thirds of patients in Switzerland with very high cardiovascular risk do not achieve LDL-C target values set out by the European Society of Cardiology,3 indicating a need for additional treatment options -

    MUNICH, Germany, and ANN ARBOR, Mich., Dec. 16, 2020 (GLOBE NEWSWIRE) -- Daiichi Sankyo Europe GmbH (hereafter, ‘Daiichi Sankyo') and Esperion Therapeutics (NASDAQ:ESPR) announced…

    - NILEMDO® (bempedoic acid) is the first oral, once-daily treatment approved in almost two decades to lower low-density lipoprotein cholesterol (LDL-C) for indicated patients -

    - Bempedoic acid and its fixed combination drug product with ezetimibe both deliver significant reductions in LDL-C when added to a statin or other lipid-lowering therapies1,2 -

    - Two-thirds of patients in Switzerland with very high cardiovascular risk do not achieve LDL-C target values set out by the European Society of Cardiology,3 indicating a need for additional treatment options -

    MUNICH, Germany, and ANN ARBOR, Mich., Dec. 16, 2020 (GLOBE NEWSWIRE) -- Daiichi Sankyo Europe GmbH (hereafter, ‘Daiichi Sankyo') and Esperion Therapeutics (NASDAQ:ESPR) announced today Swissmedic approval for NILEMDO®* (bempedoic acid) tablet and NUSTENDI®* (bempedoic acid and ezetimibe) tablet, offering new treatment options for people with high low-density lipoprotein cholesterol (LDL-C) in Switzerland.

    Bempedoic acid is the first oral, once-daily treatment option approved in the last two decades for patients who have difficulty reaching their cholesterol-lowering goals. In a recent observational study, two-thirds of patients in Switzerland with very high cardiovascular risk did not achieve LDL-C target values set out by the European Society of Cardiology.3 Patients who do not reach their LDL-C lowering goals are at increased risk for heart attack and stroke.4 Diagnosis of high cholesterol has increased among older adults in Switzerland in the past 20 years.5

    "Cardiovascular disease remains a leading cause of death in Switzerland. In 2017 it accounted for over 30% of deaths across the country, highlighting a critical need for new treatment options for the many people who are having difficulty reaching their LDL-C goals with existing lipid-lowering therapies," said Dr. Lucas Schalch, Country Manager at Daiichi Sankyo Switzerland. "Today's approval of NILEMDO® and NUSTENDI® is a pivotal milestone for patients in secondary prevention, offering them new, convenient treatment options and demonstrating another step forward in our commitment to reduce the risk of atherosclerotic cardiovascular disease."

    "Bempedoic acid is a first-in-class adenosine triphosphate-citrate lyase (ACL) inhibitor that lowers LDL-C by inhibiting cholesterol synthesis in the liver. This unique mechanism of action allows it to work alongside existing treatments," said Ashley Hall, Chief Development Officer of Esperion. "Our focus is finding convenient, affordable ways for appropriate patients to manage LDL-C. That is why we also developed a single-tablet combination of bempedoic acid and ezetimibe, to help reduce pill burden."

    Bempedoic acid and its fixed combination drug product with ezetimibe were approved in the European Union and the United States earlier this year with different labels and indications.1,6,7,8 In Europe, the products are marketed as NILEMDO® and NUSTENDI®, and in the U.S. as NEXLETOL® and NEXLIZET® (respectively).1,6,7,8 The Esperion team discovered and developed bempedoic acid, drawing on its deep expertise in developing cholesterol-lowering medicines. With strong commercial capabilities, particularly in cardiovascular medicine, Daiichi Sankyo has licensed exclusive commercialization rights to bempedoic acid and the fixed combination drug product of bempedoic acid and ezetimibe in the European Economic Area, Turkey and Switzerland from Esperion. Marketing Authorization for both products in Switzerland will be transferred to Daiichi Sankyo.

    Swissmedic approved bempedoic acid for the treatment of adults with clinically manifesting atherosclerotic cardiovascular disease (ASCVD) or heterozygous familial hypercholesterolaemia (HeFH) who need additional LDL-C lowering, as an adjunct to diet and in combination with the maximum tolerated dose of a statin with or without other lipid-lowering therapies.9 The fixed combination drug product of bempedoic acid and ezetimibe is indicated as an adjunct to diet in adults with clinically manifesting ASCVD or HeFH for patients unable to reach LDL-C goals with the maximum tolerated dose of a statin combined with ezetimibe or bempedoic acid, or patients already being treated with the combination of bempedoic acid and ezetimibe as separate tablets.10 Both approvals were supported by data from the CLEAR trial program, which included more than 3,600 high- and very-high-risk patients.9,10 The effect of bempedoic acid on cardiovascular morbidity and mortality is currently being investigated in 14,014 patients across 32 countries as part of the CLEAR Outcomes study.11

    Bempedoic acid was generally well-tolerated in clinical studies. The most commonly reported adverse reactions with bempedoic acid during pivotal trials were hyperuricaemia, pain in extremity and anaemia. The majority of adverse reactions reported with bempedoic acid were mild to moderate in severity and balanced in occurrence with adverse events in patients receiving placebo.1,6-10

    Daiichi Sankyo

    Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centred around rare diseases and immune disorders. For more information, please visit: www.daiichisankyo.com.

    Esperion Therapeutics

    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 medicines that will make a substantial impact on reducing global cardiovascular disease, the leading cause of death around the world. For more information, please visit www.esperion.com and follow us on Twitter at www.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 Esperion's commercialization plans for bempedoic acid tablet, its expectations for the market for medicines to lower LDL-C and the impact of bempedoic acid tablet in such market, including the commercial launch and the market adoption of bempedoic acid tablet in the United States and European Union. 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, delays or failures in Esperion's clinical development and commercialization plans, or approval of expanded indications, that existing cash resources may be used more quickly than anticipated, the impact of COVID-19 on our business, clinical activities and commercial development plans, and the risks detailed in Esperion's filings with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and 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.

    References

    * This medicinal product is subject to additional monitoring in the European Union



    (1) European Medicines Agency. NILEMDO® Summary of Product Characteristics. 27 Nov 2020: https://www.ema.europa.eu/en/documents/product-information/nilemdo-epar-product-information_en.pdf.

    (2) Pinkosky SL, et al. Liver- specific ATP-citrate lyase inhibition by bempedoic acid decreases LDL-C and attenuates atherosclerosis. Nature Communications. 2016; 7:13457. DOI:10.1038/ncomms13457.

    (3) Rachamin Yael, et al. "Statin treatment and LDL target value achievement in Swiss general practice – a retrospective observational study," 27 May 2020. Swiss Med Wkly. 2020;150:w20244: https://smw.ch/article/doi/smw.2020.20244

    (4) WHO. Cardiovascular diseases (CVDs) Factsheet. 2017. Available online at: https://www.who.int/en/news-room/fact-sheets/detail/cardiovascular-diseases-(cvds). Last accessed December 2020.

    (5) Swiss Federation Federal Statistical Office report, Gesundheitsstatistik 2019, 29 Oct 2019: https://www.bfs.admin.ch/bfsstatic/dam/assets/10227275/master;

    (6) European Medicines Agency. NUSTENDI® Summary of Product Characteristics. 27 Nov 2020: https://www.ema.europa.eu/en/documents/product-information/nustendi-epar-product-information_en.pdf.

    (7) U.S. Food and Drug Administration. NEXLETOL® Prescribing Information. 27 Nov 2020: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211616s000lbl.pdf.

    (8) U.S. Food and Drug Administration. NEXLIZET® Prescribing Information. 27 Nov 2020: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211617s000lbl.pdf.

    (9) Swissmedic. NILEMDO® (bempedoic acid) Product Information for Human Medicinal Products. December 2020.

    (10) Swissmedic. NUSTENDI® (bempedoic acid and ezetimibe) Product Information for Human Medicinal Products. December 2020.

    (11) Stephen J Nicholls et al, Rationale and design of the CLEAR-outcomes trial: Evaluating the effect of Bempedoic acid on cardiovascular events in patients with statin intolerance, American Heart Journal (2020), https://doi.org/10.1016/j.ahj.2020.10.060

    Contacts:

    Daiichi Sankyo Europe GmbH

    Dr. Wolfgang Schiessl (Europe)

    Director Product PR and Communications, Cardiovascular Europe

    +49 151 1714 7317

    Esperion



    Primary Logo

    View Full Article Hide Full Article
  4. ANN ARBOR, Mich., Dec. 15, 2020 (GLOBE NEWSWIRE) -- Esperion (NASDAQ:ESPR) today announced the appointment of Sheldon Koenig, a proven leader in the cardiovascular market, as chief operating officer, effective today. Koenig will report directly to Tim M. Mayleben, president and chief executive officer of Esperion. Koenig joins the executive team of Esperion and will provide vision, leadership, strategy and operations expertise to further evolve Esperion into a commercial leader in cardiovascular medicine, as well as a highly successful, efficiently operated global company.  

    "Sheldon brings an incredible amount of relevant experience to our company that will be familiar to all of our stakeholders. His commercial knowledge and applied learnings…

    ANN ARBOR, Mich., Dec. 15, 2020 (GLOBE NEWSWIRE) -- Esperion (NASDAQ:ESPR) today announced the appointment of Sheldon Koenig, a proven leader in the cardiovascular market, as chief operating officer, effective today. Koenig will report directly to Tim M. Mayleben, president and chief executive officer of Esperion. Koenig joins the executive team of Esperion and will provide vision, leadership, strategy and operations expertise to further evolve Esperion into a commercial leader in cardiovascular medicine, as well as a highly successful, efficiently operated global company.  

    "Sheldon brings an incredible amount of relevant experience to our company that will be familiar to all of our stakeholders. His commercial knowledge and applied learnings in directly correlated launches will be invaluable to us and we are pleased to have him join Esperion," said Tim M. Mayleben, president and chief executive officer of Esperion. "Sheldon is the right leader at the right time to navigate our company through the opportunities that lie ahead of us as we continue a period of rapid growth as a company in 2021 and beyond."

    Koenig is an accomplished leader in the cardiovascular space and brings over 25 years of leadership roles to Esperion. Most recently, he served as executive vice president and chief commercial officer of Portola pharmaceuticals until it was acquired by Alexion. At Portola, Koenig and his team delivered $130M+ in Andexxa® sales in the first year of commercialization, making it one of the top five most successful hospital launches in 30 years. Prior to joining Portola, Koenig was senior vice president and head of the cardiovascular franchise for Sanofi where he led U.S. business operations and product launches in more than 20 countries. Previously, he served as vice president and global brand leader for the cardiovascular division of Merck & Co, Inc. where, for more than 25 years, he took on roles of increasing responsibility within the Company's cardiovascular and thrombosis franchises and led marketing for the launch of ezetimibe.

    "Joining Esperion gives me the opportunity to make a meaningful impact on an organization that has incredible potential to make a difference in the lives of patients where currently marketed medicines fall short," said Koenig. "The company is in a unique position to deliver with two recently approved and launched medicines in a market that is neglected in terms of innovation and where physicians and patients alike can benefit from additional therapeutic options. I am excited to join Esperion at such an exciting stage and apply the collective learnings from my complementary experiences to help execute on the Esperion mission of lipid management for everyone."

    Koenig will assume responsibility for the commercial team at Esperion. As part of today's announcement, Mark Glickman, chief commercial officer, will leave Esperion, effective immediately. "I want to thank Mark and recognize his contribution in building our commercial function and laying the initial groundwork in which our company can grow," said Mayleben.

    ESPERION Therapeutics

    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 medicines that will make a substantial impact on reducing global cardiovascular disease, the leading cause of death around the world. For more information, please visit www.esperion.com and follow us on Twitter at www.twitter.com/EsperionInc.

    CLEAR Cardiovascular Outcomes Trial

    The effect of bempedoic acid on cardiovascular morbidity and mortality has not been determined. ESPERION 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 are considered "statin averse." The CVOT — known as CLEAR Cardiovascular Outcomes Trial — is an event-driven, global, randomized, double-blind, placebo-controlled study that completed enrollment in August 2019 of over 14,000 patients with hypercholesterolemia and high CVD risk at over 1,400 sites in 32 countries.

    ESPERION Therapeutics' Commitment to Patients with Hyperlipidemia

    High levels of LDL-C can lead to a build-up of fat and cholesterol in and on artery walls (known as atherosclerosis), potentially leading to cardiovascular events, including heart attack and stroke. In the U.S., 96 million people, or more than 37 percent of the adult population, have elevated LDL-C. There are approximately 18 million people in the U.S. living with elevated levels of LDL-C despite taking maximally tolerated lipid-modifying therapy — including individuals considered statin averse — leaving them at high risk for cardiovascular events1. In the United States, more than 50 percent of atherosclerotic cardiovascular disease (ASCVD) patients and heterozygous familial hypercholesterolemia (HeFH) patients who are not able to reach their guideline recommended LDL-C levels with statins alone need less than a 40 percent reduction to reach their LDL-C threshold goal2.

    ESPERION's mission as the Lipid Management Company is to deliver oral, once-daily medicines that complement existing oral drugs to provide the additional LDL-C lowering that these patients need.

    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 Esperion's commercialization plans for bempedoic acid tablet, its expectations for the market for medicines to lower LDL-C and the impact of bempedoic acid tablet in such market, including the commercial launch and the market adoption of bempedoic acid tablet in the United States and European Union. 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, delays or failures in Esperion's clinical development and commercialization plans, or approval of expanded indications, that existing cash resources may be used more quickly than anticipated, the impact of COVID-19 on our business, clinical activities and commercial development plans, and the risks detailed in Esperion's filings with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and 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.

    References

    (1) ESPERION market research on file: research project interviewing 350 physicians. ESPERION Therapeutics, Inc. Sept-Oct 2018.

    (2) Data on file: analysis of NHANES database. ESPERION Therapeutics, Inc. 2018.

    All registered trademarks are property of their respective owners.

    Contact:

    Ben Church

    ESPERION



    734-864-6774

     



    Primary Logo

    View Full Article Hide Full Article
  5. - Significant mean reduction of 26.5% in LDL-C with bempedoic acid vs. placebo in pooled analysis of people who cannot tolerate statins1 -

    - Analysis by sex showed bempedoic acid significantly lowered LDL-C at week 12 in males and females* vs. placebo2 -

    ANN ARBOR, Mich., Nov. 13, 2020 (GLOBE NEWSWIRE) -- Esperion (NASDAQ:ESPR) today announced results of pooled data from four of the company's Phase 3 trials were presented at the virtual American Heart Association Scientific Sessions 2020 (AHA 2020). Both analyses demonstrated significant lowering of low-density lipoprotein cholesterol (LDL-C) by NEXLETOL® (bempedoic acid) Tablets by week 12 in specific subgroups, including people who cannot tolerate statins and females, compared to placebo…

    - Significant mean reduction of 26.5% in LDL-C with bempedoic acid vs. placebo in pooled analysis of people who cannot tolerate statins1 -

    - Analysis by sex showed bempedoic acid significantly lowered LDL-C at week 12 in males and females* vs. placebo2 -

    ANN ARBOR, Mich., Nov. 13, 2020 (GLOBE NEWSWIRE) -- Esperion (NASDAQ:ESPR) today announced results of pooled data from four of the company's Phase 3 trials were presented at the virtual American Heart Association Scientific Sessions 2020 (AHA 2020). Both analyses demonstrated significant lowering of low-density lipoprotein cholesterol (LDL-C) by NEXLETOL® (bempedoic acid) Tablets by week 12 in specific subgroups, including people who cannot tolerate statins and females, compared to placebo.     

    "Women are half of the population, and nearly 10 million patients in the U.S. with high LDL-C levels are not on statins due to tolerability issues,3 yet these groups have been underrepresented in previous medical research,4" said Ashley Hall, Chief Development Officer for Esperion. "Our goal at Esperion is lipid management for everybody, and these analyses show significant LDL-C efficacy and acceptable safety for NEXLETOL in these subgroups."

    In "Efficacy and Safety of Bempedoic Acid in Patients Who Cannot Tolerate Any Dose of a Statin: Pooled Analysis from Phase 3 Clinical Trials," (Abstract #P2139) data from a subgroup of more than 580 patients not receiving any dose of a statin showed a significant mean reduction of 26.5% (p< 0.001) in LDL-C by week 12 with NEXLETOL vs. placebo. NEXLETOL was generally well tolerated, with treatment-emergent adverse events (TEAEs) comparable across the bempedoic acid and placebo groups.1

    The poster "Efficacy and Safety of Bempedoic Acid by Sex: Pooled Analyses From Phase 3 Trials" (Abstract #P742) showed NEXLETOL significantly lowered LDL-C at week 12 in both sexes compared with placebo for a pooled population of more than 3,600 patients across four studies. LDL-C lowering was numerically greater in females compared with males across both pools of the study: The placebo-corrected mean reduction was 27.7% for females vs. 22.1% for males (interaction p value=0.079) in the statin-intolerant pool, and 21.2% for females vs. 17.4% for males (interaction p value=0.044) in the pool of patients with atherosclerotic cardiovascular disease (ASVCD) and/or heterozygous familial hypercholesterolemia (HeFH) who were receiving background maximally tolerated statin. Bempedoic acid was generally well tolerated by both sexes.2

    Approved earlier this year by the U.S. Food and Drug Administration (FDA) and launched at the height of the COVID-19 pandemic, NEXLETOL is the first oral, once-daily, non-statin LDL-C-lowering medicine available to indicated patients in nearly 20 years. The approval of NEXLETOL was supported by a global pivotal Phase 3 LDL-C-lowering program conducted in more than 3,000 patients with ASCVD and/or HeFH. In these studies, NEXLETOL provided an average of 18% placebo-corrected LDL-C lowering when used with moderate or high-intensity statins. The most common (incidence ≥ 2% and greater than placebo) adverse reactions were upper respiratory tract infection, muscle spasms, hyperuricemia, back pain, abdominal pain or discomfort, bronchitis, pain in extremity, anemia and elevated liver enzymes. NEXLETOL is indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with HeFH or established ASCVD who require additional lowering of LDL-C. The effect of NEXLETOL on cardiovascular morbidity and mortality has not yet been determined. Please see important safety information below.

    *Note: Esperion strives to be inclusive in our both research and our language, and we follow the language guidance outlined in "Reporting Sex, Gender, or Both in Clinical Research?" from The Journal of the American Medicine Association (JAMA).

    NEXLETOL® (bempedoic acid) Tablet

    NEXLETOL is a first-in-class ATP Citrate Lyase (ACL) inhibitor that lowers LDL-C by reducing cholesterol biosynthesis and up-regulating the LDL receptors. NEXLETOL is the first oral, once-daily, non-statin LDL-C lowering medicine approved in the U.S. in nearly 20 years for patients with ASCVD or HeFH. NEXLETOL was approved by the FDA in February 2020.

    Indication and Limitation of Use

    NEXLETOL is indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease who require additional lowering of LDL-C. The effect of NEXLETOL on cardiovascular morbidity and mortality has not been determined.

    Important Safety Information

    • Warnings and Precautions:
      • Elevations in serum uric acid have occurred. Assess uric acid levels periodically as clinically indicated. Monitor for signs and symptoms of hyperuricemia, and initiate treatment with urate-lowering drugs as appropriate. The risk for gout events with NEXLETOL® (bempedoic acid) tablet was higher in patients with a prior history of gout although gout also occurred more frequently than placebo in patients treated with NEXLETOL™ (bempedoic acid) tablet who had no prior gout history.
      • Tendon rupture has occurred. Discontinue NEXLETOL® (bempedoic acid) tablet at the first sign of tendon rupture. Avoid NEXLETOL® (bempedoic acid) tablet in patients who have a history of tendon disorders or tendon rupture.
    • Adverse Reactions:
    • Drug Interactions:
      • Avoid concomitant use of NEXLETOL with simvastatin greater than 20 mg.
      • Avoid concomitant use of NEXLETOL with pravastatin greater than 40 mg.

    You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088 or report side effects to Esperion at 833-377-7633 (833 ESPRMED).

    Please see the full Prescribing Information for NEXLETOL by clicking here.

    Esperion Therapeutics

    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 medicines that will make a substantial impact on reducing global cardiovascular disease, the leading cause of death around the world. For more information, please visit www.esperion.com and follow us on Twitter at www.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 commercialization plans for bempedoic acid tablet. 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, delays or failures in Esperion's clinical development and commercialization plans, or approval of expanded indications, that existing cash resources may be used more quickly than anticipated, the impact of COVID-19 on our business, clinical activities and commercial development plans, and the risks detailed in Esperion's filings with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and 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.

    References

    1 Laufs U, et al. Efficacy and Safety of Bempedoic Acid in Patients who Cannot Tolerate Any Does of a Statin: Pooled Analysis from Phase 3 Clinical Trials. Presentation at the American Heart Association Virtual Scientific Sessions 2020. November 2020.

    2 Goldberg AC, et al. Efficacy and Safety of Bempedoic Acid by Sex: Pooled Analyses From Phase 3 Trials. Presentation at the American Heart Association Virtual Scientific Sessions 2020. November 2020.

    3 ZS Associates primary and secondary research, Sep-Oct 2018. Primary research N = 350 healthcare practitioners

    4 J Tamargo, G Rosano, T Walther, J Duarte, A Niessner, JC Kaski, C Ceconi, H Drexel, K Kjeldsen, G Savarese, C Torp-Pedersen, D Atar, BS Lewis, S Agewall, Gender differences in the effects of cardiovascular drugs, European Heart Journal - Cardiovascular Pharmacotherapy, Volume 3, Issue 3, July 2017, Pages 163–182, https://doi.org/10.1093/ehjcvp/pvw042

    Contact:

    Kaitlyn Brosco

    Esperion



    Primary Logo

    View Full Article Hide Full Article
View All Esperion Therapeutics Inc. News