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
Meiji Seika Pharma: Results from the Global Phase III Trial (Integral-2) of Nacubactam, a Novel β-Lactamase Inhibitor, Highlighted in The Lancet Microbe’s Coverage of ESCMID Global Congress 202617.7.2026 03:00:00 CEST | Press release
Meiji Seika Pharma Co., Ltd. (Headquarters: Tokyo, President and Representative Director: Toshiaki Nagasato) today announced that results from the global Phase III trial (Integral-2) of nacubactam (Development Code: OP0595), a novel β-lactamase inhibitor, were highlighted in The Lancet Microbe’s coverage of ESCMID Global Congress 2026 (held in Munich, Germany). As highlighted in The Lancet Microbe’s coverage, the key findings presented by Meiji Seika Pharma at ESCMID Global Congress 2026 are as follows: The Integral-2 study (jRCT2031230076) is a global Phase III clinical trial that enrolled patients with complicated urinary tract infections, acute uncomplicated pyelonephritis, hospital-acquired bacterial pneumonia, ventilator-associated bacterial pneumonia, or complicated intra-abdominal infections caused by carbapenem-resistant Gram-negative bacteria (excluding Acinetobacter species). The study has achieved the prespecified study objectives. For the primary endpoint of overall treatme
Yoshihiro Shimamura Joins the Marché du Film’s “Investors Circle 2026” as an Invited Investor, Backing a New Feature Film17.7.2026 03:00:00 CEST | Press release
Shimamura Yoshihiro Film Production Co., Ltd. (Head office: Osaka, Japan; Representative Director: Yoshihiro Shimamura), a company active in film production and investment, today announced that Representative Director Yoshihiro Shimamura has decided to invest in an international feature film after being invited to the “Investors Circle 2026” — a distinction that reflects his standing as one of the field’s most highly regarded producers and investors. Hosted by the Marché du Film, the business arm of the Festival de Cannes and one of the world’s largest film markets, the Investors Circle is an invitation-only summit that connects a select group of private investors with high-end feature films during early-stage financing. Held in Cannes, France, May 16-17, 2026, it brings internationally acclaimed directors and producers together with investors around a curated slate of projects in development. During the summit, Shimamura attended private pitching sessions and, after individual meeting
Takeda’s Zasocitinib Demonstrates Consistent, High Rates of Skin Clearance Across the Body, Including Hard-to-Treat and High-Impact Sites, in Phase 3 Psoriasis Studies17.7.2026 00:00:00 CEST | Press release
On average, about 75% of patients with scalp psoriasis treated with zasocitinib achieved clear or almost clear skin at week 16 Approximately 70% of patients with palmoplantar disease treated with zasocitinib achieved clear or almost clear skin at week 16 Zasocitinib demonstrated statistically significant improvements in Nail Psoriasis Severity Index (NAPSI) versus placebo Results reinforce the potential of zasocitinib to deliver rapid and durable skin clearance, including in the hardest-to-treat areas, in a convenient once-daily pill Takeda (TSE:4502/NYSE:TAK) announced new data from the two pivotal Phase 3 studies of zasocitinib (TAK-279), a next-generation, highly selective and potent oral tyrosine kinase 2 (TYK2) inhibitor, in adults with moderate-to-severe plaque psoriasis (PsO).1 Presented at the 2026 American Academy of Dermatology (AAD) Innovation Academy, these secondary endpoint data show that zasocitinib demonstrated consistent and high rates of skin clearance across hard-to-
Merz Completes Inaugural €450 Million Schuldschein Loan Issuance16.7.2026 23:36:00 CEST | Press release
Debut transaction more than three times oversubscribed The Merz Group has successfully completed its first-ever Schuldschein loan issuance, placing a total volume of €450 million in the debt capital market – a multiple of three relating to the launch volume. The debut transaction was significantly oversubscribed and attracted strong interest from all investor groups. The proceeds were settled and paid out today. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260716926041/en/ Dr. Almuth Steinkühler, Chief Financial Officer Merz Group The transaction comprises both fixed- and floating-rate tranches with maturities of three, five, seven, and ten years. Around 50 German and international investors participated, representing a broad range of institutions, including private banks, German federal state-owned banks, public savings banks, cooperative banks, pension funds and occupational pension institutions. With the successful plac
The Estée Lauder Companies Appoints Madeleine Boyd as Senior Vice President, Global Brand Communications16.7.2026 22:22:00 CEST | Press release
The Estée Lauder Companies Inc. (NYSE: EL) today announced the appointment of Madeleine Boyd as Senior Vice President, Global Brand Communications, effective July 20, 2026. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260716738393/en/ Photo by Esteban La Tessa As part of the company’s continued efforts to strengthen how its brands better connect with consumers, Ms. Boyd will establish and lead a newly integrated Global Brand Communications team. In this role, she will ensure the company’s diverse portfolio is anchored by a cohesive enterprise communications strategy, while accelerating bold, consumer-first storytelling that drives earned media, cultural relevance, and brand desirability. She will also strengthen creator engagement, helping the company’s brands gain attention where culture is being shaped. Ms. Boyd brings extensive experience spanning brand strategy, communications, consumer engagement, and cultural insight
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