DAIICHI-SANKYO
10.6.2020 09:02:04 CEST | Business Wire | Press release
Daiichi Sankyo Europe GmbH (hereafter, ‘Daiichi Sankyo’) today announced that the first patients have been enrolled in a multinational, prospective, observational study that will assess, in a real-world setting, the effectiveness of current treatment and management of low-density lipoprotein cholesterol (LDL-C) levels in 8,000 patients with hypercholesterolaemia at high and very high risk of cardiovascular events. The study will recruit patients from approximately 800 sites in 14 countries across Europe.
“The evidence is clear that the lower the LDL-C level achieved, the lower the risk of cardiovascular events such as ischaemic heart attack and strokes, and this is reflected in the latest European Society of Cardiology guidelines,” said Professor Alberico L. Catapano, Chairperson of the guidelines Task Force and Professor of Pharmacology at the Department of Pharmacological and Biomolecular Sciences, University of Milan and Multimedica IRCCS, Italy. “The SANTORINI study will provide important insights into how patients are currently being managed and the effectiveness of the treatments they are receiving. This in turn will help us identify opportunities to improve care in clinical practice.”
“During this unprecedented time many people are avoiding clinics and hospitals for fear of contracting the SARS-CoV-2 virus, but this prevents them accessing important treatment for cardiovascular disease. Daiichi Sankyo has been working closely with SANTORINI trial sites to ensure we follow local recommendations to progress the study in the most effective and safest way possible,” said Dr. Inaam Haq, Medical Affairs Director, Antithrombotic & Cardiovascular at Daiichi Sankyo Europe. “Cardiovascular disease kills over four million people in Europe every year, and up to 80% of people taking statins do not reach target LDL-C levels, which means they are at increased risk of a heart attack or stroke. Daiichi Sankyo is committed to addressing this human and economic burden and ensuring the SANTORINI study is able to go ahead and provide us with key insights to support these patients.”
Daiichi Sankyo Europe has exclusive commercialisation rights to bempedoic acid, which is being developed as a first-in-class, affordable, convenient, once-daily, oral therapy for people with hypercholesterolaemia who are unable to reach LDL-C goals after optimised oral lipid-lowering therapies and remain at high risk of a cardiovascular event, such as a heart attack or stroke. Bempedoic acid and the bempedoic acid / ezetimibe fixed dose combination (FDC) tablet was approved by the U.S. Food and Drug Administration in February 2020 and by the European Commission in March 2020.
- ENDS -
About SANTORINI
The SANTORINI study is a multinational, prospective, observational study that will enrol 8,000 patients from 800 sites in 14 countries across Europe. The primary objective is to document, in the real-world setting, the effectiveness of current treatment modalities in managing plasma levels of LDL-C in high- and very high-risk patients requiring lipid-lowering therapies. The study population consists of high- and very high-risk patients previously diagnosed and treated as well as newly diagnosed and requiring treatment.
Only data from routine clinical practice will be documented and physicians will not be required to perform any mandatory assessment outside the routine clinical practice. To facilitate accurate recording of data, patients can optionally fill in a memory aid to note important details. Data collection is estimated to finish in Q4 of 2021 with a final report of the study results estimated for Q4 of 2022.
Bempedoic acid
With a targeted mechanism of action, bempedoic acid is a first-in-class, oral, once-daily ATP Citrate Lyase (ACL) inhibitor that reduces cholesterol synthesis in the liver and thereby lowers circulating LDL-C levels.1,2 It is intended for patients with hypercholesterolaemia and/or at high risk of atherosclerotic cardiovascular disease (ASCVD) who need additional LDL-C lowering despite maximally-tolerated statin therapy.
Bempedoic acid has a unique mechanism of action which is complementary, yet distinct from other lipid-lowering therapies, such as statins.3 Due to its liver-specific mechanism, bempedoic acid has a reduced potential to induce the muscle-related side effects commonly associated with statin therapy and provide additional LDL-C lowering on top of statin monotherapy in clinical trials.
Daiichi Sankyo Europe has licensed exclusive commercialisation rights to these products in the European Economic Area and Switzerland from Esperion.
About 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 .
1
Ray KK, et al.
Safety and Efficacy of Bempedoic Acid to Reduce LDL Cholesterol. N Engl J Med.
2019; 380:1022–32.
2
Ballantyne CM, et al.
Efficacy and safety of bempedoic acid added to ezetimibe in statin-intolerant patients with hypercholesterolemia: A randomized, placebo-controlled study. Atherosclerosis
.2018;277:195–203.
3
Laufs U, et al.
Efficacy and Safety of Bempedoic Acid in Patients with Hypercholesterolemia and Statin Intolerance. J Am Heart Assoc.
2019;8(7): e011662.
View source version on businesswire.com: https://www.businesswire.com/news/home/20200610005045/en/
Link:
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Siren Fusion 2026: The Convergence of People, Technology and Ideas4.3.2026 14:30:00 CET | Press release
An Invitation-Only Summit for Global Intelligence, National Security and Investigative Leaders Siren today announced Siren Fusion 2026, its inaugural global summit convening senior investigators, national security leaders and AI innovators for a high-trust forum on the future of investigative intelligence. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260304240853/en/ Siren Fusion 2026 is the convergence of people, technology and ideas, in Galway, Ireland. An invitation-only summit for global intelligence, national security and investigative leaders. Taking place in Galway, Ireland, Fusion is the deliberate convergence of people, technology and ideas within a national security frame. Structured as an educational and strategic forum rather than a conventional conference, Fusion 2026 focuses on the issues that now define the intelligence and law enforcement agenda: Geopolitical instability AI-driven investigative transformati
Mary Kay Goes for Gold in Global Manufacturing Standards4.3.2026 14:11:00 CET | Press release
Quality, Certified: Mary Kay Achieves ISO 22716 Mary Kay Inc., a global direct sales leader in beauty and skincare innovation, has achieved ISO 22716 certification, the internationally recognized gold standard for cosmetic Good Manufacturing Practices (GMP), reinforcing the company’s unwavering commitment to product quality, safety, and consumer trust worldwide. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260304100367/en/ Chaun Harper, Chief Supply Chain Officer at Mary Kay Inc., emphasized the broader significance of the milestone: “At Mary Kay, quality is not a checkbox – it is a promise, an operational framework, and a culture. (Photo Credit: Mary Kay Inc.) Key Data Points About Mary Kay’s Global Manufacturing: Built on 26 acres of land, Mary Kay’s state-of-the-art, Silver LEED-certified Richard R. Rogers Manufacturing and R&D Center (R3) is located in Lewisville, Texas. R3 is a $100+ million investment and is a 453,00
NelsonHall Recognizes LTM as a Leader in GenAI & Process Automation for Banking4.3.2026 13:45:00 CET | Press release
LTM, the Business Creativity partner to the world’s largest enterprises, has been recognized as a Leader in the ‘Overall’ market segment in the NelsonHall NEAT Evaluation for GenAI & Process Automation in Banking 2025. In the NEAT framework, Leaders are vendors that demonstrate high capability relative to peers in delivering immediate client benefit while also meeting future client requirements. The recognition positions LTM among the top-performing vendors evaluated for their ability to deliver both immediate business impact and long-term innovation capability in GenAI and process automation services for the banking sector. The evaluation highlights LTM’s depth of experience in financial services, which accounts for a large portion of its overall revenues, and its focused investments in GenAI, agentic AI, and process automation capabilities delivered through its BlueVerse™ platform. LTM has digital agents dedicated to manage GenAI and process automation services, supporting banking cl
Americhem Expands Aircraft Interior Portfolio with PFAS-Free Thermoplastic Platform Meeting 55/55 OSU, Low Smoke, and Low Toxicity Requirements4.3.2026 13:00:00 CET | Press release
Americhem is expanding its aircraft interior materials portfolio with ColorFast® SFT5500, a PFAS-free high-performance thermoplastic engineered to meet FAA 14 CFR 25.853, Appendix F, Part IV, 55/55 OSU heat release requirements while delivering low smoke and low toxicity characteristics for aircraft interior applications. PFAS-free thermoplastic systems capable of achieving 55/55 OSU performance while maintaining low smoke and low toxicity characteristics remain limited in the aerospace market. ColorFast® SFT5500 addresses this need with demonstrated 55/55 OSU heat release performance, low smoke emission characteristics, and low flaming-mode toxicity performance in a high-performance thermoplastic platform designed specifically for injection-molded interior components. Aircraft interior thermoplastics must meet stringent fire standards while maintaining durability, thermal stability, and process consistency. As legacy fluorinated material systems face increasing regulatory scrutiny, ma
NETSCOUT Reveals Qualitative Shifts in DDoS Attack Sophistication, Infrastructure Capacity, and Threat Actor Capabilities4.3.2026 12:05:00 CET | Press release
AI Adoption, coordinated botnets, and persistent hacktivists groups drove millions of attacks NETSCOUT® SYSTEMS, INC. (NASDAQ: NTCT), today released its second half of the year 2025 Distributed Denial-of-Service (DDoS) Threat Intelligence Report, revealing sophisticated attacker collaboration, resilient botnets, and compromised IoT infrastructure that drove more than eight million DDoS attacks worldwide – some as large as 30 terabits per second (Tbps) – marking a new era of hyper-scale, coordinated threat activity that continues to outpace global takedown efforts. Meanwhile, the accelerating growth of DDoS-for-hire services is empowering a broader range of threat actors, intensifying operational risk to digitally connected organizations and enterprises. Implications for security professionals extend far beyond volumetric concerns and include reconnaissance and adaptive evasion which challenge traditional defense paradigms. Organizations must match adversarial innovation with intelligen
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom