TOKYO, June 27, 2016 /CNW/ -- Daiichi Sankyo Co., Limited (hereafter, Daiichi Sankyo) (TSE: 4568) today announced that it has entered into an agreement with Servier Canada (Laval, Quebec) whereby Servier Canada will market the oral, once-daily anti-coagulant edoxaban in Canada, if approved by the Canadian health authority.
Daiichi Sankyo filed a New Drug Submission for edoxaban with the Health Products and Food Branch (HPFB) of Health Canada in August 2015.
Edoxaban is an oral, once-daily anticoagulant that specifically inhibits factor Xa, which is an important factor in the coagulation system that leads to blood clotting. The global edoxaban clinical trial program includes two phase 3 clinical studies, Hokusai-VTE and ENGAGE AF-TIMI 48 (Effective aNticoaGulation with Factor XA Next GEneration in Atrial Fibrillation). The results from these trials formed the basis of the New Drug Submission in Canada for edoxaban for the prevention of stroke and systemic embolic events (SEE) in patients with nonvalvular atrial fibrillation (NVAF), as well as for the treatment of venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE), and the prevention of recurrent VTE.
"We are pleased to partner with Servier Canada, a well-established and respected organization with extensive expertise in marketing cardiovascular products in Canada," says Ken Keller, President, U.S. Commercial, Daiichi Sankyo, Inc., who is responsible for commercial oversight of the partnership in Canada. "This partnership will further broaden the availability of edoxaban to patients in need of this important oral, once-daily anti-coagulant."
It is estimated that atrial fibrillation affects about 350,000 Canadians, a number that is expected to increase as the population ages1, and that VTE affects up to 45,000 Canadians per year2. Under the agreement, Daiichi Sankyo will receive an upfront payment, payments based on regulatory and commercial milestones, as well as royalties on net product sales. Further financial details are not being disclosed.
Edoxaban has been approved in the U.S., EU, Switzerland, Japan, South Korea, Taiwan and Hong Kong. Edoxaban is marketed as Savaysa® in the U.S. and as Lixiana® elsewhere.
About Daiichi Sankyo
Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical products to address diversified, unmet medical needs of patients in both mature and emerging markets. With over 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 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 hypertension and thrombotic disorders, under the Group's 2025 Vision to become a "Global Pharma Innovator with a Competitive Advantage in Oncology," Daiichi Sankyo research and development is primarily focused on bringing forth novel therapies in oncology, including immuno-oncology, with additional focus on new horizon areas, such as pain management, neurodegenerative diseases, heart and kidney diseases, and other rare diseases. For more information, please visit: www.daiichisankyo.com.
Daiichi Sankyo, Inc.
This press release contains forward-looking statements and information about future developments in the sector, and the legal and business conditions of DAIICHI SANKYO Co., Ltd. Such forward-looking statements are uncertain and are subject at all times to the risks of change, particularly to the usual risks faced by a global pharmaceutical company, including the impact of the prices for products and raw materials, medication safety, changes in exchange rates, government regulations, employee relations, taxes, political instability and terrorism as well as the results of independent demands and governmental inquiries that affect the affairs of the company. All forward-looking statements contained in this release hold true as of the date of publication. They do not represent any guarantee of future performance. Actual events and developments could differ materially from the forward-looking statements that are explicitly expressed or implied in these statements. DAIICHI SANKYO Co., Ltd. assume no responsibility for the updating of such forward-looking statements about future developments of the sector, legal and business conditions and the company.
1 Canadian Stroke Prevention Intervention Network. Available at: http://www.cspin.ca/patients/fast-facts/
2 Tagalakis V, et al. Incidence of and mortality from venous thromboembolism in a real-world population: the Q-VTE Study Cohort. Am J Med. 2013;126: 13–21.
SOURCE Daiichi Sankyo