Business Wire

Daiichi Sankyo’s SANTORINI Study Gets Underway, Investigating Cholesterol Care Across Europe

Share

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.

Contact information

Wolfgang Schiessl (Europe)
Daiichi Sankyo Europe GmbH
Communications & Product PR Europe
+49 (89) 7808498

About Business Wire

Business Wire
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

Taulia’s Darcy Douglas Named One of the Top Women in Supply Chain23.9.2020 19:30:00 CESTPress release

Taulia, the leader in working capital technology solutions, has today announced Darcy Douglas, VP of Professional Services, has been listed as a recipient of Supply & Demand Chain Executive’s first Women in Supply Chain award. The award recognizes female leaders in the supply chain industry who have demonstrated a commitment to excellence in their respective roles and also supporting other women to develop their careers and skills. Darcy has been at Taulia for ten years and her leadership has helped the company grow from a small start-up to an established market leader in the supply chain finance industry. During her time at Taulia, Darcy has spearheaded the creation of three leadership and professional development programs that help Taulians boost their skills and enhance their careers. Specifically, Darcy created the Leadership Initiative for Taulia (LIFT) program for women, which includes a mentoring program, education classes, and other activities, to inspire development and leader

DC Secretary Announces Proposed Amendments to DC Rules23.9.2020 17:22:00 CESTPress release

DC Administration Services, Inc., in its capacity as DC Secretary, has today published to the DC website proposed amendments to the Deliverable Obligation and External Review provisions of the DC Rules. Any Eligible Market Participant may provide comments on the proposed amendments to the DC Rules until 5:00pm EDT Tuesday, September 29, 2020. The proposed amendments to the DC Rules, together with additional information about the Determinations Committees and what they do can be found at the Determinations Committees website: https://www.cdsdeterminationscommittees.org/. Other inquires may be directed to Mark Ferraris at mark.ferraris@citadelspv.com View source version on businesswire.com: https://www.businesswire.com/news/home/20200923005724/en/Contact information Mark Ferraris mark.ferraris@citadelspv.com

MIRIS: Green Growth in the Midst of a Pandemic23.9.2020 16:19:00 CESTPress release

In March 2020, also Norway ran out of infection control equipment. In this critical phase, MIRIS, a top tier technology green real estate company, initiated a collaboration with China Development Integration Limited (CDIL), a major EPC integration corporation in the Silk Road initiative. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200923005669/en/ From left to right: Henrik Berg Klemmetsen, Magdalena Urbanik, Danny Wong, Andy Lai , Davis Chiu Xinwen Chang and Jan Gunnar Mathisen. Frame: Edmund Amir. (Photo: Business Wire) The two companies have a relationship with regards to building a large-scale smart city in Europe, and MIRIS realized the possibility of a cooperation with CDIL and its resources to ensure supply of high quality infection control equipment. Together they fulfilled significant contracts regarding infection control equipment for several countries, including Norway. In a market described as the "Wild West",

CORRECTING and REPLACING S ES Becomes Microsoft Azure Orbital Founding Connectivity Partner23.9.2020 15:38:00 CESTPress release

Second paragraph of release dated September 22, 2020 should read: The first MEO and Earth Observation gateways will be located in the United States; in Phoenix, Arizona and Quincy, Washington respectively.(instead of ... located in Phoenix, Arizona, United States and Quincy, Western Australia respectively). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200922005927/en/ SES Becomes Microsoft Azure Orbital Founding Connectivity Partner (Photo: Business Wire) The updated release reads: SES BECOMES MICROSOFT AZURE ORBITAL FOUNDING CONNECTIVITY PARTNER SES’s proven low-latency MEO managed services to be part of Microsoft’s new multi-orbit satellite connectivity integrated with Azure, promising optimized cloud application performance for O3b mPOWER customers SES today announced it has joined as the medium Earth orbit (MEO) connectivity partner for Microsoft Azure Orbital, Microsoft’s new managed service enabling network operators

CORRECTING and REPLACING SES Advances Digital Transformation with Cloud-First Strategy, Expanded Agreement23.9.2020 15:36:00 CESTPress release

Eighth paragraph of release dated September 22, 2020 should read: The two companies will make joint investments in Azure Orbital ground stations for the MEO and Earth Observation segments that SES will deploy and manage based on its industry expertise, with the first Earth Observation gateway being located at Quincy, Washington in the United States. (instead of ... with the first Earth Observation gateway being located at Quincy, Western Australia.). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200922005930/en/ SES Advances Digital Transformation with Cloud-First Strategy, Expanded Agreement (Photo: Business Wire) The updated release reads: SES ADVANCES DIGITAL TRANSFORMATION WITH CLOUD-FIRST STRATEGY, EXPANDED AGREEMENT Multi-year agreement with Microsoft includes Azure Orbital integration, SES’s expanded use of Azure and joint development of new video and data connectivity services SES today announced plans to significan

Former World Head of State to Address Attendees at Everbridge’s COVID-19: Road to Recovery (R2R) Symposium, Joining Dr. Anthony Fauci, Sir Richard Branson, and Dr. Sanjay Gupta as Keynotes, October 14-15, 202023.9.2020 15:29:00 CESTPress release

Everbridge, Inc. (NASDAQ: EVBG), the global leader in critical event management (CEM), today announced that a former World Head of State will address attendees to its Autumn 2020 “COVID-19 R2R: The Road to Recovery” virtual leadership summit to be held October 14-15, 2020, covering the path forward amid the COVID-19 pandemic. The addition of a former World Head of State represents the latest in a top-tier line-up of leading experts and C-level executives who will share their perspectives on best practices for the safe reintegration of people back to work, campuses and public spaces; the restoration of revenue-generating operations; and the protection of citizens on a countrywide scale amid the coronavirus pandemic. Keynote speakers include presidential advisor and Director of the National Institute of Allergy and Infectious Diseases (NIAID) at the U.S. National Institutes of Health (NIH) Dr. Anthony Fauci, Virgin Group Founder Sir Richard Branson, and renowned neurosurgeon and CNN Chie

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