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
TOURISE and Oxford Economics Release New Global Report on Tourism Resilience in an Era of Permanent Disruption17.8.2026 16:33:00 CEST | Press release
New analysis shows destinations that assume risk will recover up to 1.5 times faster with global rehabilitation times dropping from 24 months to as little as 10 TOURISE, in collaboration with Oxford Economics, today released a new report, “Resilience in a World that Doesn’t Reset: Redesigning Tourism for an Era of Permanent Disruption.” The analysis of 85 major crises over two decades shows a clear pattern: in a world defined by continuous shocks, destinations that act before disruption hits recover up to 1.5 times faster than those that wait. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260817880835/en/ “In a world that does not reset between crises, disruption is a constant feature of the global tourism landscape,” said His Excellency Ahmed Al-Khateeb, Minister of Tourism of Saudi Arabia and Chairman of TOURISE. “The real test for destinations measures how they prepare for volatility, protect traveler confidence, and mai
The Expensify Visa® Commercial Card Brings New Proactive Spend Controls to 14 Countries17.8.2026 15:00:00 CEST | Press release
New admin-defined spend rules let businesses control how, where, and when every card is used, stopping the wrong spend before it happens instead of cleaning it up after. Expensify, Inc. (Nasdaq: EXFY), the easiest way to manage expenses, travel, and corporate cards, today expanded the reach of Expensify Card spend rules, the market-leading way for businesses to control corporate card spend before it happens. Available to businesses in 14 countries, spend rules let admins decide exactly how, where, and when each Expensify Card can be used, so only compliant transactions go through. Unlike traditional corporate cards that rely on after-the-fact expense review, the Expensify Card enforces policy at the point of purchase. Admins set the rules once, and the card handles the rest. With Expensify Card spend rules, admins can: Lock a card to a subscription. Give each recurring SaaS tool its own virtual card, so a vendor can only ever charge what it should. If the card owner changes teams or le
Riskified Analysis Finds Travel Fraudsters Are Adapting Faster Than Traditional Signals Can Keep Up, With May Flight Risk Up 32%17.8.2026 14:30:00 CEST | Press release
New Travel Industry report reveals sophisticated fraud rings are exploiting trusted customer behaviors across flights, hotels, and travel platforms Riskified (NYSE: RSKD), a global leader in ecommerce fraud and risk intelligence, today released new findings from its Travel Industry Insights report, revealing how sophisticated fraud rings and AI-enabled fraudsters are evolving their tactics across airlines, hotels, and online travel platforms. Riskified’s analysis shows that fraudsters are increasingly adapting their behavior to resemble legitimate travelers, making traditional fraud indicators less reliable and creating new challenges for travel merchants. Riskified’s analysis of hundreds of millions of travel transactions across flights, hotels, and land transportation found that flight fraud risk increased through the first five months of 2026, with May 2026 marking the sharpest year-over-year increase at 32% compared to May 2025. The findings show that sophisticated fraud activity i
PIF Delivers Strong Revenue and Profit Growth in 202517.8.2026 13:54:00 CEST | Press release
Revenue rose 9% to $120 billion while net profit more than doubled to $17 billionCumulative domestic investments reached more than $199 billion since 2021PIF has contributed more than $342 billion to Saudi Arabia’s real non-oil GDP between 2021 and 2025Assets under management exceed $900 billion, up from around $530 in 2021 and $150 billion in 2015 PIF today published its 2025 Annual Report demonstrating strong financial performance and continued progress against its long-term objectives. As a long-term investor with a unique mandate to drive the economic transformation of Saudi Arabia and deliver sustainable financial returns, PIF maintained a diversified portfolio in 2025, balancing returns with national impact and long-term resilience. Maintaining Financial Discipline In 2025, revenue rose 9% year on year to $120 billion, while net profit more than doubled to $17 billion, supported by stronger contributions from maturing portfolio companies. PIF retained over $900 billion in assets
Foundever Successfully Closes a Holistic Recapitalization, Reducing its Debt by Nearly $900 Million and Strengthening its Financial Position for Long-Term Growth17.8.2026 13:30:00 CEST | Press release
Secures $225 Million Equity Infusion; Revolving Credit Facility and Term Loan Maturities ExtendedBenoit Leclercq Appointed Interim Chief Executive Officer to Lead Foundever Through its Next Phase of Growth; Company Begins Formal Search Process for Permanent CEO Foundever Group S.A.® (“Foundever” or the “Company”) – a global leader in integrated customer experience, digital operations and analytics services, today announced that it has successfully closed a holistic recapitalization (the “Transaction”) in coordination with 95.4% of the lenders under its term loan facility (“Term Loan Lenders”), 100% of its revolving credit facility lenders (“RCF Lenders”), and the Company’s existing majority shareholders. The Transaction meaningfully strengthens Foundever’s financial foundation and positions the Company to invest in its growth strategy. Key terms of the Transaction include: Company's existing majority shareholders invest $225 million into common equity. Term loan facility exchange reduc
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