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
Mobix Labs Signs Definitive Agreement to Acquire Vision Aerial, Accelerating Global Drone Platform for National Security and Aerial Intelligence24.7.2026 13:00:00 CEST | Press release
Transaction accelerates Mobix Labs’ global aerial intelligence strategy and National Security Matters Initiative Mobix Labs, Inc. (Nasdaq: MOBX) today announced that it has signed a definitive agreement to acquire Vision Aerial, Inc., a U.S.-based designer and manufacturer of American-built, National Defense Authorization Act (NDAA)-compliant unmanned aerial systems. The definitive agreement moves the transaction beyond the previously announced letter of intent and represents a major step toward closing an acquisition that would expand Mobix Labs into one of the world’s most important technology growth markets: secure drones, autonomous aerial systems and aerial intelligence for national security, critical infrastructure, energy, public safety, industrial inspection and government operations. Vision Aerial’s customers and end-users include the U.S. Air Force, U.S. Navy, government agencies, energy and utility operators, research institutions and other organizations requiring performanc
Enhertu® Plus Pertuzumab Recommended for Approval in the EU by CHMP as First-Line Treatment for Patients with HER2 Positive Metastatic Breast Cancer24.7.2026 13:00:00 CEST | Press release
Recommendation based on DESTINY-Breast09 phase 3 trial results that showed Enhertu plus pertuzumab reduced the risk of disease progression or death by 44% versus THP with a median progression-free survival exceeding three years If approved, Daiichi Sankyo and AstraZeneca’s Enhertu plus pertuzumab would become first new treatment in the EU in more than a decade for first-line HER2 positive metastatic breast cancer Enhertu® (trastuzumab deruxtecan) in combination with pertuzumab has been recommended for approval in the European Union (EU) for the first-line treatment of adult patients with unresectable or metastatic HER2 positive (immunohistochemistry [IHC] 3+ or in-situ hybridization [ISH]+) breast cancer. Enhertu is a specifically engineered HER2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca (LSE/STO/NYSE: AZN). The Committee for Medicinal Products for Human Use (CHMP)
SLB Announces Second-Quarter 2026 Results24.7.2026 12:50:00 CEST | Press release
Revenue of $8.97 billion increased 3% sequentially and 5% year on year GAAP EPS of $0.52 increased 4% sequentially and decreased 30% year on year EPS, excluding charges and credits, of $0.55 increased 6% sequentially and decreased 26% year on year Net income attributable to SLB of $786 million increased 5% sequentially and decreased 22% year on year Adjusted EBITDA of $1.90 billion increased 7% sequentially and decreased 7% year on year Cash flow from operations was $1.36 billion and free cash flow was $716 million Board approved quarterly cash dividend of $0.295 per share SLB (NYSE: SLB) today announced results for the second-quarter 2026. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260722694386/en/ The exterior of the SLB headquarters in Houston, Texas.Second-Quarter Results(Stated in millions, except per share amounts)Three Months EndedChangeJun. 30, 2026Mar. 31, 2026Jun. 30, 2025SequentialYear-on-yearRevenue $8,972 $8
NIQ Expands GenAI Capabilities Across gfknewron, Turning Trusted Intelligence into Decisions Faster24.7.2026 12:30:00 CEST | Press release
New capabilities help businesses uncover trends faster, simplify complex analysis, and accelerate confident decision-making NIQ (NYSE: NIQ), a leader in consumer intelligence, today announced the expansion of AI-powered Smart Insights across its gfknewron® platform. By bringing together markets and categories into a single view, gfknewron enables businesses to transform complex market, consumer and supply chain data into clear, actionable intelligence quickly. The latest enhancements help users identify trends, opportunities and performance drivers more quickly, reducing the time required to analyze large datasets and accelerating confident decision-making across teams. As brands and retailers face growing pressure to respond quickly to changing consumer behavior and market dynamics, the ability to unlock meaningful insights from increasingly rich datasets has become a significant competitive advantage. As AI is only as effective as the intelligence behind it, Smart Insights helps busi
Thales to Strengthen Romania’s Airspace Protection With Twelve Ground Master 200 MM/A Radars24.7.2026 10:05:00 CEST | Press release
The Romanian General Directorate for Armaments and the French Direction Générale de l’Armement (DGA – the French defence procurement agency) have signed an agreement to supply twelve Thales GM200 Multi-Mission All-in-one (GM200 MM/A) radars to protect the Romanian airspace. This government-to-government agreement underlines the high level of partnership between France and Romania, within the framework of the European Union’s SAFE funding programme, in order to bolster Europe’s defence capabilities. The GM200 MM/A is part of Thales’ proven Ground Master radar family, which has already been deployed in over 40 countries, including now in Romania. In a context of growing collaboration between European nations to bolster collective security, the Romanian General Directorate for Armaments has just signed a landmark agreement with France’s Direction Générale de l’Armement (DGA) to acquire twelve Thales Ground Master 200 Multi-Mission All-in-one (GM200 MM/A) radars. This government-to-governm
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