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
IQM Quantum Computers Becomes First European Quantum Computing Company Listed on a Major U.S. Exchange2.7.2026 16:47:00 CEST | Press release
IQM begins trading on Nasdaq Global Select Market under the ticker symbol “IQMX” Company enters next phase of growth as a publicly traded leader in full-stack superconducting quantum computing IQM maintains a strong pro forma cash position of EUR 337 million IQM Quantum Computers (Nasdaq: IQMX) (“IQM”, “IQM Quantum Computers” or the “Company”), a global leader in full-stack superconducting quantum computers, today became a publicly traded company following the completion of its business combination with Real Asset Acquisition Corp. (“RAAQ”). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260702960460/en/ IQM Quantum Computers Becomes First European Quantum Computing Company Listed on a Major U.S. Exchange The company’s American Depositary Shares begin trading today on the Nasdaq Global Select Market under the ticker symbol “IQMX”. The listing marks a major milestone for IQM establishing the company as the first European quan
GigaDevice Launches First GD24CL Series I²C EEPROM, Further Expanding Its Non-Volatile Memory Portfolio2.7.2026 16:00:00 CEST | Press release
GigaDevice, a leading semiconductor company specializing in Flash memory, 32-bit microcontrollers (MCUs), sensors, and analog products, announced today the launch of its new GD24CL series I²C EEPROM. The series delivers outstanding performance, comprehensive security protection mechanisms, and excellent reliability that addresses the stringent requirements for stable and long-term storage of critical configuration data. These offered features will benefit applications in industrial, energy, Internet-of-Things (IoT), data centers, and networking. As GigaDevice’s first EEPROM product series, the launch further enhances the company’s non-volatile memory portfolio and provides customers with more dynamic storage solutions. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260702394554/en/ GigaDevice Launches First GD24CL Series I²C EEPROM, Further Expanding Its Non-Volatile Memory Portfolio. The GD24CL series is designed with high
Medical University of Graz Enrolls First Patient in DEEPER CHALLENGE Trial Evaluating Spur® Peripheral Retrievable Scaffold System in a Select CLTI Cohort2.7.2026 13:00:00 CEST | Press release
Reflow Medical, Inc. announces that the Medical University of Graz has enrolled the first patient in the DEEPER CHALLENGE clinical trial. This investigator-initiated, single-center, single-arm, prospective study, supported by a grant, investigates early vessel recoil following below-the-knee treatment using the Spur® Peripheral Retrievable Scaffold System in combination with a commercially available drug-coated balloon. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260701995624/en/ The study investigates early vessel recoil following below-the-knee treatment using the Spur® Peripheral Retrievable Scaffold System in combination with a commercially available drug-coated balloon. The study plans to enroll up to 40 patients with chronic limb-threatening ischemia (CLTI) across two distinct cohorts: patients with diabetes and patients with end-stage renal disease receiving hemodialysis for at least six months, with women comprisi
Compass Pathways Announces New Employee Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)2.7.2026 12:30:00 CEST | Press release
Compass Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health, announced today that Compass granted equity awards under the Compass Pathways plc 2026 Inducement Plan to eight newly hired non-executive employees. The equity awards were granted on July 1, 2026 and consisted of options to purchase an aggregate of 63,685 shares and restricted share units or, in the case of employees in the United Kingdom nominal cost options, covering an aggregate of 30,300 shares. The options have an exercise price per share equal to $13.29, the closing price of the Company’s American Depositary Shares on the Nasdaq Global Select Market on the grant date, and will vest over a four-year period with 25% vesting on the first anniversary of the date of the grant and the remaining 75% vesting in equal monthly installments over the three-year period thereafter, subject to each employee’s continued employment. The restricted sh
Infobip Launches PitchMate — An AI Fan Companion for Global Football2.7.2026 12:00:00 CEST | Press release
Two AI agents. Two global sports. One platform redefining what it means to be a fan. Global AI-first cloud communications platform Infobip launched PitchMate, a new AI-powered conversational agent that brings football fans closer to the action of the world’s biggest football tournament. Purpose-built for the global football audience, PitchMate joins the TGR Haas F1 Team RaceMate — Infobip’s AI fan engagement solution for the TGR Haas F1 Team — in demonstrating how conversational AI is transforming fan engagement across sports worldwide. RaceMate, launched last April for this year’s motorsport season, is an AI agent on WhatsApp and Apple Messages for Business that puts TGR Haas F1 Team fans at the center of the action. It delivers real-time race data, personalized content, team radio highlights, trivia, and native multilingual support, turning passive viewers into active participants through natural, human-like conversations across every race weekend. Since its launch, RaceMate has reac
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