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
HOF Capital Completes €1 Billion Acquisition of Porsche’s Stakes in Bugatti Rimac and Rimac Group9.9.2026 18:00:00 CEST | Press release
HOF Capital today announced the completion of its acquisition of Porsche’s equity interests in Bugatti Rimac and Rimac Group through an HOF-led consortium. The transaction, first announced in April 2026, closed following the satisfaction of all conditions, including regulatory clearances. Porsche’s combined interests were valued at approximately €1 billion. HOF Capital originated and led the transaction, assembling a consortium of institutional investors from the United States and Europe. Following completion of the transaction, HOF holds a 23.5% stake and becomes the largest shareholder in Rimac Group, which holds the 55% controlling interest in Bugatti Rimac. HOF and its consortium also acquired Porsche’s direct 45% interest in Bugatti Rimac. As part of the investment, HOF Capital holds three supervisory board seats across Rimac Group and Bugatti Rimac. Hisham Elhaddad, Co-Founder and Managing Partner of HOF Capital, has joined the Supervisory Boards of both Bugatti Rimac and Rimac G
The Rock-It Company Expands Dynamic Dox to Provide ATA Carnet Services Across the US and Canada9.9.2026 17:00:00 CEST | Press release
Expansion provides access and expert ATA Carnet services for customers across new regions The Rock-It Company announced today the expansion of Dynamic Dox, the industry-leading provider of ATA Carnets, to now service partners and projects based in the United States, Canada and beyond. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260909137375/en/ Following over a decade of expertise and leading service across the United Kingdom since 2014, Dynamic Dox will now provide new regions with dedicated document preparation for time-sensitive logistics projects, and urgent ATA Carnets for international shipments and critical business travel needs. The news of the expansion follows Dynamic Dox’s recent brand refresh, introducing an updated identity and connection to The Rock-It Company as Dynamic Dox By Rock-It. The expansion is led by Amanda Barlow, VP of Global ATA Carnets at The Rock-It Company, who has helped to drive the platfor
Ennov Appoints Oxana Pickeral as Chief Executive Officer9.9.2026 16:00:00 CEST | Press release
Ennov (the “Company”), a global provider of a unified compliance platform that streamlines regulatory, clinical, quality, and pharmacovigilance operations for life sciences and healthcare companies, today announced the appointment of Dr. Oxana Pickeral as Chief Executive Officer. Founder and outgoing CEO, Olivier Pâris, will join Ennov’s Board of Directors and continue to support the company as a Strategic Advisor. Dr. Pickeral has spent her career at the forefront of innovation in life sciences technology, from her early work on the Human Genome Project to growing Amazon Web Services’ Healthcare & Life Sciences partner business, enabling modern cloud solutions across the industry. She joins Ennov most recently from Honeywell, where she served as Global Software and Connected Life Sciences business leader, and previously as President and CEO of Sparta Systems, a Honeywell company. Across her leadership roles, she has successfully scaled global companies at the intersection of life scie
Three Chugai Researchers Behind the Discovery of Hemlibra for Hemophilia A Receive Prestigious U.S. Lasker Award, One of the World’s Most Respected Scientific Honors9.9.2026 15:45:00 CEST | Press release
- Recognized for the invention of a bispecific antibody that transformed treatment paradigm through an unconventional approach – Recognized for realizing a novel drug discovery concept in which a bispecific antibody replaces the function of coagulation Factor VIII, which is deficient in hemophilia A. Provided improved convenience through prolonged activity and subcutaneous administration, and provided a treatment option regardless of factor VIII inhibitors, thereby helping address unmet medical needs in hemophilia A. First time since the establishment of the Lasker Foundation in 1945 that three Japanese researchers have received the award simultaneously. Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) today announced that Dr. Kunihiro Hattori (former Senior Fellow of Chugai), Dr. Takehisa Kitazawa (Deputy Head of Research Division, Chugai), and Dr. Tomoyuki Igawa (Head of Research Division, Chugai), who led the creation of Hemlibra (emicizumab), a treatment for hemophilia A, have been aw
AMCS Appoints Richard Humphrey as Chief Product and Technology Officer9.9.2026 15:00:00 CEST | Press release
Industrial software executive to lead global product strategy and accelerate AI innovation AMCS, a leading technology provider for the waste and recycling industry, today announced the appointment of Richard Humphrey as Chief Product and Technology Officer. Based in Boston, Humphrey will lead the company’s global product organisation. Humphrey brings more than 25 years of experience developing software for construction and other complex industrial environments. He joins AMCS as the company deepens its focus on waste and recycling and expands the role of AI across its platform. Most recently, Humphrey served as Chief Product and Technology Officer at Contruent, where he led product strategy for a construction cost-management platform used on major capital programmes. He previously held vice president roles at Bentley Systems and B2W Software. Earlier in his career, he spent more than a decade at Autodesk, where he led its Civil Design and Construction software business as Senior Directo
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