Daiichi Sankyo Europe and Esperion Announce Validation of the Marketing Authorisation Application (MAA) for Bempedoic Ac

Publicado 28/02/2019 13:00:42CET

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 CLEAR Outcomes -- is an event-driven, randomised, double-blind, placebo-controlled study expected to enroll approximately 12,600 patients with hypercholesterolemia and high CVD risk at over 1,000 sites in approximately 30 countries.(6)

About Daiichi Sankyo

Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical products to address diversified, unmet medical needs of patients in both mature and emerging markets. With over 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 hypertension and thrombotic disorders, under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology", Daiichi Sankyo research and development is primarily focused on bringing forth novel therapies in oncology, including immuno-oncology, with additional focus on new horizon areas, such as pain management, neurodegenerative diseases, heart and kidney diseases, and other rare diseases. For more information, please visit: www.daiichisankyo.com [http://www.daiichisankyo.com/].

About Esperion

Esperion is the Lipid Management Company passionately committed to developing and commercialising 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 fixed dose combination tablet, are targeted therapies that have been shown to significantly lower 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 [https://www.globenewswire.com/Tracker?data=1NvFdRmbfEMzSaojbKhmdxXKvwZUKUOhUgflski2_TpDrtQsUnOihBcRqR79h9fJhK3i83JBcfZcRn-4QLiQVQ==] and follow us on Twitter at https://twitter.com/EsperionInc [https://www.globenewswire.com/Tracker?data=YrEllBFTjcZKgMWIdh-Gcknbe868MWotok9QyulQnh5ljinPidgYeMkuiB42ZiXwCE0Zd4YC_cCNm28jXAX0443o0ivBjN9l56IxkF0H6W_IsqYjxfLAI-39XYj5kG575FIc8kTlf69DwA1nG3R7rEMzrKR0mhYBvGD-XiyYlJdMgqiIvNu0ZUv5jPhCYv9xZIlAge64XBnNkvVtfkUgrRJvPfQRbGtZDt6T4TEI17TD7p5aUMkGJn6nKhoOKHr6QpMGUvnNSg067uPgUmMojPmGDM7Ncy3lmplCuvzNBmO2dgag5bPJ3gj661_uxgDx].

Product Communications Contact:
Lydia Worms
Daiichi Sankyo Europe GmbH

Investor Contact:
Alex Schwartz
+1-734-249-3386aschwartz@esperion.com [https://www.globenewswire.com/Tracker?data=i9jpTWYd5kClfc9KaJOf5oRMO4uKlHTJLHimdCeCC7hOVLOy0aR86YTxJaT9350QMhOfY6f52ErcgTDJbZY8fRSwOcuBQnnwAnq6R-tV2foCPHI_MvS5H1yGYszzvgwWUFH4njSCkkCbgfSmu-Uhz8zf-M2hmLjqtDqZlMZtM_MRdWWQ-yChN-_05Esx0mOSBAbPf3WHQTgL2URM8mtMnElQw9eUKsldF8QhPsddaYRMowYpF6BGCoZx88jYX-TKBPTzuEA4AvkX8x-wLkirSA==]


(1) Pinkosky L. et al. Liver-specific ATP-citrate lyase inhibition by bempedoic acid decreases LDL-C and attenuates atherosclerosis. Nature. 2016: 10.1038.

(2) Phase 3 Top-Line Results from Study 2 & Cumulative Phase 3 Program Results. Esperion Investor Presentation. Oct 29, 2018. Available at https://investor.esperion.com/static-files/32936da0-96f9-40e5-a12b-bd00ece6698d [https://investor.esperion.com/static-files/32936da0-96f9-40e5-a12b-bd00ece6698d]. Last accessed December 12, 28 Feb. (3) - Rosei EA et al. Management of Hypercholesterolemia, Appropriateness of Therapeutic Approaches and New Drugs in Patients with High Cardiovascular Risk. High Blood Press Cardiovasc Prev. 2016; 23(3): 217-230.

(4) Thompson PD et al. Treatment with ETC-1002 alone and in combination with ezetimibe lowers LDL cholesterol in hypercholesterolemic patients with or without statin intolerance. Journal of Clinical Lipidology. 2016; 10:5560567.

(5) Top-Line Results from the Bempedoic Acid / Ezetimibe Combination Pill Phase 3 Study. Esperion Investor Presentation. Aug 27, 2018. Available at https://investor.esperion.com/static-files/1639de53-9494-4299-98a5-0b6f1317678a [https://investor.esperion.com/static-files/1639de53-9494-4299-98a5-0b6f1317678a]. Last accessed December 12, 2018.

(6) Evaluation of Major Cardiovascular Events in Patients With, or at High Risk for, Cardiovascular Disease Who Are Statin Intolerant Treated with Bempedoic Acid (ETC-1002) or Placebo (CLEAR Outcomes). Available at https://clinicaltrials.gov/ct2/show/NCT02993406?term=bempedoic+acid&rank=4 [https://clinicaltrials.gov/ct2/show/NCT02993406?term=bempedoic+acid&rank=4]. Last accessed December 12, 2018.

February 2019, BEM/19/0001

Web site: http://www.daiichisankyo.com/http://www.esperion.com/


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