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
Quaise Energy Raises $134 Million in Initial Close of Series B to Build World’s First Superhot Geothermal Power Plant7.7.2026 14:01:00 CEST | Press release
Prelude Ventures led the round, with participation from JERA Co., Inc., Japan's largest power generation company, and Idemitsu Kosan, one of Japan's largest integrated energy companies Series B equity is the first component of a diverse financing that includes project-level capital and debt Quaise's millimeter wave drilling system is approaching one kilometer of depth at its Central Texas field site Series B proceeds fund Project Obsidian in Central Oregon, the world’s first commercial superhot geothermal power plant Quaise Energy, a leading developer of utility-scale superhot geothermal energy, today announced the first close of its Series B financing, raising $134 million with additional equity and debt capital expected to close imminently. The round was led by Prelude Ventures, with strategic investments from JERA and Idemitsu, two of Japan's largest energy companies. Nearly all existing investors, including Safar Partners, participated in the round. This press release features mult
UMA Unveils Its Vision for the Next Generation of Humanoid Robots7.7.2026 14:00:00 CEST | Press release
At Machina Summit, UMA unveils the design of its first humanoid robot and introduces Real-Time Learning, a new AI architecture that enables robots to learn new skills through demonstration rather than programming. At Machina Summit, UMA, a Physical AI company, unveiled the design of its first humanoid robot and introduced Real-Time Learning, a learning architecture that enables robots to acquire new skills through demonstration instead of manual programming. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260707215927/en/ The announcement comes as aging populations, industrial reshoring, and the energy transition place increasing pressure on labor markets across advanced economies. According to Korn Ferry, the global economy could face a shortage of 85 million workers by 2030, representing as much as $8.5 trillion in unrealized economic output. Against this backdrop, UMA is developing a new generation of intelligent robots bu
Biocytogen and Whitehawk Therapeutics Enter Global Collaboration for Bispecific Antibody ADC Development7.7.2026 14:00:00 CEST | Press release
Biocytogen (SSE: 688796; HKEX: 02315) and Whitehawk Therapeutics, Inc. (“Whitehawk,” Nasdaq: WHWK) today announced a global collaboration to develop bispecific antibody-drug conjugates (BsADC). Biocytogen will provide access to up to five bispecific antibodies using its proprietary RenLite® platform, and Whitehawk will evaluate these in combination with its ADC linker-payload platform technologies. Whitehawk then has the option to advance any resulting BsADC candidates as part of its pipeline. Based on a common light-chain design, RenLite® supports the discovery, screening, and optimization of fully human bispecific antibodies across diverse target combinations, while reducing the risk of light-chain mispairing and providing a robust molecular foundation for subsequent BsADC development. By bringing together the complementary capabilities of Biocytogen and Whitehawk, the collaboration aims to identify BsADC candidates with differentiated targeting profiles and therapeutic potential. “W
Bregal Milestone III Closes at its Increased Hard Cap of €915 Million7.7.2026 13:00:00 CEST | Press release
Oversubscribed fundraise with global institutional backing Bregal Milestone (“Milestone” or the “Firm”), a leading European software private equity firm, today announced the final close of its third fund, Bregal Milestone III (“Fund III” or the “Fund”), at its increased hard cap of €915 million. The Fund was oversubscribed and marks a significant broadening of the Firm’s global investor base. Completed in eight months from first close and achieved against a challenging fundraising environment, the result reflects the strength of Milestone’s AI-centric approach and demonstrable track record. Jan Bruennler, Philippe Lautenberg and Cyrus Shey, Co-Founders and Managing Partners at Bregal Milestone, commented: “Bregal Milestone III reflects strong conviction in our approach to investing in mission-critical European software, AI and cybersecurity businesses and helping them scale. We are thankful for the support and confidence shown by our limited partners, both longstanding and new, and rem
HTEC and Embotech Partner to Scale Deployment of Autonomous Driving Solutions for Industrial Logistics7.7.2026 12:39:00 CEST | Press release
HTEC, a global technology and AI engineering company headquartered in Silicon Valley, and Embotech, a global leader in safety-certified Level 4 autonomous driving solutions for industrial logistics, today announced a strategic partnership to scale deployment of Embotech's autonomous driving solutions across vehicle platforms, customer programmes and industrial sites. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260707870943/en/ HTEC, a global technology and AI engineering company headquartered in Silicon Valley, and Embotech, a global leader in safety-certified Level 4 autonomous driving solutions for industrial logistics, today announced a strategic partnership to scale deployment of Embotech's autonomous driving solutions across vehicle platforms, customer programmes and industrial sites. The partnership comes as Embotech’s proven autonomous driving solutions are being adopted across a growing number of vehicle platforms
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