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

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

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

 MYPINPAD The World’s First to Achieve PCI Accreditation for Contactless Payments on Mobile and Tablet14.7.2020 02:01:00 EESTPress release

MYPINPAD, the global leader in secure personal authentication solutions is the first company in the world to achieve Payment Card Industry (PCI) Security Standards Council (SSC) certification for its Android software-based Contactless Payments on Commercial off-the-shelf (CPoC) solution, enabling contactless payments on smart devices. As the first solution globally certified to accept contactless payments on these devices without requiring additional hardware, this significant step accelerates unparalleled possibilities in customer experience innovation for merchants and other businesses in the payments chain. Accreditation for MYPINPAD’s contactless payment solution follows the company’s recent PCI SSC SPoC certification for its software only PIN Entry solution for iOS and Android (PIN on mobile), also a global first. The combined capability of tap and PIN on smart mobile devices means a 100 percent software-based payments future. It enables all merchants globally to democratise payme

Emirates Mars Mission Announces the Live Stream Link to the Launch of the "Hope Probe"13.7.2020 23:55:00 EESTPress release

The Emirates Mars Mission has announced the link to watch the live streaming of the launch of the "Hope Probe", starting at midnight UAE Time [20:00 GMT] on Tuesday 14 July, on www.emm.ae/live This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200713005675/en/ The Hope Probe (Photo: AETOSWire) The link provides an opportunity for everyone to witness this historic event, which is the first interplanetary mission from the Arab World. The probe is being launched from the Tanegashima Space Center in Japan at 00:51:27 UAE Time on 15 July [20:51 GMT on 14 July], marking an important milestone as part of the promising Emirati project to explore the Red Planet. The launch is the culmination of efforts of a large team of young Emirati cadres, comprising 200 engineers, experts and researchers, who over the past six years have prepared for this moment and ensured that all scientific and logistical preparations to control the Probe mission

Ergomotion is Prepared for the Accelerated Growth Surge in the Adjustable Bed Base Category13.7.2020 23:29:00 EESTPress release

Ergomotion, the largest manufacturer of adjustable bases worldwide, is prepared for the accelerated growth in the furniture and mattress industry. As the rest of the world was dealing with the expanding pandemic, Ergomotion was learning from their parent company Keeson Technology, in China. Located in the first country to experience COVID-19, Keeson was uniquely positioned to provide valuable insight to how partners and consumers would react to the unexpected crisis in other parts of the world. Additionally, they were able to re-open quickly following the extended Chinese New Year holiday which limited supply disruptions. “Treating our customers as partners and looking at our shared business from their perspective has been a focus of Ergomotion’s in a time where uncertainty is prevalent,” says Johnny Griggs, Chief Operating Officer at Ergomotion. The Ergomotion team is prepared to build on current relationships within the industry and provide support through the pandemic with a better

Bentley Systems’ Acceleration Fund Announces Launch of The Cohesive Companies, Advancing Infrastructure Digital Twins to Improve Asset Performance13.7.2020 17:01:00 EESTPress release

Bentley Systems, Incorporated, a leading global provider of comprehensive software and digital twins services for advancing the design, construction, and operations of infrastructure, today announced that its Acceleration Fund has launched The Cohesive Companies, a wholly owned subsidiary, anchored by the acquisition of Atlanta-based Cohesive Solutions. The new business venture will include the services team from Bentley’s AssetWise business and the offerings of Bentley, Cohesive, and IBM’s Maximo to support the digital transformation of infrastructure owner-operators. The Cohesive Companies will act as a digital integrator to help infrastructure asset owners upgrade their enterprise environments to leverage digital twins—digital representations and simulations of a physical asset, synchronizing digital context (current existing conditions), digital components (engineering content), and digital chronology (lifecycle change management). Infrastructure digital twins can empower asset ope

Rimini Street Appoints Gerard Brossard as COO13.7.2020 16:00:00 EESTPress release

Rimini Street, Inc. (Nasdaq: RMNI), a global provider of enterprise software products and services, the leading third-party support provider for Oracle and SAP software products and a Salesforce partner, today announced the appointment of Gerard Brossard to the newly created role of executive vice president and chief operating officer (COO). Brossard is responsible for Rimini Street’s global field operations and the global sales and success of the Company’s Support and Application Management Services for Oracle and SAP products. Brossard reports directly to Rimini Street CEO, Seth A. Ravin. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200713005192/en/ Rimini Street Appoints Gerard Brossard as COO (Photo: Business Wire) New COO Brings Proven Capabilities to Support Accelerating Company Growth Prior to joining Rimini Street, Brossard served as executive vice president and general manager of Rackspace’s Global Solutions and S

Become a Pet Trainer in the Newest Mabinogi “P.E.T.” Update Arriving on July 1613.7.2020 16:00:00 EESTPress release

Mabinogi, Nexon’s free-to-play fantasy MMORPG will be receiving the delightful new “P.E.T.” update on July 16! Following the introduction of Mabinogi’s exciting furry pets in the “My Little Pet” update, the World of Erinn is changing with the addition of more powerful Fynn Pets. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200713005083/en/ Mabinogi P.E.T. (Graphic: Business Wire) While the recent “My Little Pet” update expanded activities for pets embarking on expeditions to explore the world of Erinn, the P.E.T. update challenges players with a new Pet Training talent to discover the Power of the Fynn and set out to unlock stronger Fynn Pets. To unlock Fynn Pets, players need to sync their main pet with other pets using Fynn Sync. The Fynn Pet will receive the Power of the Fynn, increasing a pet’s max level, inventory, summoning time and more! With the update, players can also defeat monsters to obtain Fynni Gems and bloo

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