Updated on 27 June 2016
Singapore: Japanese drug manufacturer Daiichi Sankyo Co Limited has entered into an agreement with Servier Canada. The agreement allows Servier Canada to market the oral, once-daily anti-coagulant edoxaban in Canada, if approved by the Canadian Health authorities.
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 III 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."
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 were not 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 US and as Lixiana elsewhere.