Daiichi Sankyo Co., Limited 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, US 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 ages, and that VTE affects up to 45,000 Canadians per year.
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 US, EU, Switzerland, Japan, South Korea, Taiwan and Hong Kong. Edoxaban is marketed as Savaysa in the US and as Lixiana elsewhere.