Servier Canada has agreed to market Daiichi Sankyo’s edoxaban in Canada, in an agreement hinging upon approval of the oral, once-daily anticoagulant by the country’s health agency.
The value of the agreement was not disclosed. Daiichi Sankyo did say, however, that it will receive an upfront payment, as well as payments tied to achieving regulatory and commercial milestones and royalties on net product sales.
Edoxaban is under review by Health Canada, whose Health Products and Food Branch received Daiichi Sankyo’s new drug submission for the Factor Xa inhibitor in August 2015.
The submission seeks approval of edoxaban for the prevention of stroke and systemic embolic events in patients with nonvalvular atrial fibrillation, as well as for the treatment of venous thromboembolism (VTE), including deep vein thrombosis and pulmonary embolism, and the prevention of recurrent VTE.
Daiichi Sankyo’s submission was based upon results from two Phase III clinical studies, Hokusai-VTE and ENGAGE AF-TIMI 48 (Effective aNticoaGulation with Factor XA Next GEneration in Atrial Fibrillation).
Edoxaban is marketed in the U.S. as Savaysa® and as Lexiana® elsewhere in the world. In addition to the U.S., Edoxaban has been approved for use in the EU, Switzerland, Japan, South Korea, Taiwan, and Hong Kong.
During the fiscal year that ended March 31, Daiichi Sankyo reported worldwide edoxaban sales of ¥15.0 billion ($147.6 million), including ¥0.4 billion ($3.9 million) in U.S. sales. U.S. sales shrunk from ¥0.7 billion ($6.9 million) the previous fiscal year, though global sales more than doubled during the period, rising 102.2% from ¥4.3 billion ($42.3 million).
“We are pleased to partner with Servier Canada, a well-established and respected organization with extensive expertise in marketing cardiovascular products in Canada,” Ken Keller, president, U.S. commercial, Daiichi Sankyo, who is responsible for commercial oversight of the partnership in Canada, said in a statement.
Earlier this year, Servier Canada launched Viacoram® (perindopril arginine and amlodipine), indicated for mild-to-moderate essential hypertension in patients for whom combination therapy is appropriate, following approval by Health Canada in January.
The company’s cardiovascular products also include Lozide® (indapamide), indicated for mild-to-moderate high blood pressure, and Coversyl® (perindopril erbumine), which is indicated for hypertension, congestive heart failure, and reduction of cardiovascular risk in patients with hypertension or postmyocardial infarction and stable coronary disease.