Janssen Pharmaceutica NV entered into an exclusive distribution agreement for INVOKANA® (canagliflozin) and VOKANAMET® (a fixed-dose combination of canagliflozin and metformin) in countries in the European Economic Area (EEA) and Switzerland where the products have obtained Pricing and Reimbursement Approvals. The agreement with Mundipharma Medical Company (“Mundipharma”) became effective on 21st August 2017 in all concerned countries except in the UK and Italy where the agreement will become effective on 16 September.
Additional EEA countries may be added to this agreement after gaining local Pricing and Reimbursement Approvals.
As a result of this agreement, Mundipharma becomes the exclusive distributor for both products in the concerned countries, with exclusive rights to promote, distribute, and sell the products through its network of independent associated companies.
Janssen’s affiliate, Janssen-Cilag International NV, remains Marketing Authorisation Holder (MAH) in the concerned countries (for Switzerland Janssen-Cilag AG remains MAH). Under the agreement, Janssen maintains manufacturing responsibilities and will continue to be responsible for certain regulatory activities, including Marketing Authorisation updates and pharmacovigilance in close collaboration with Mundipharma and its associated companies.
“We at Janssen are committed to providing the best possible outcomes for people with type 2 diabetes and to ensuring Invokana and Vokanamet get to the people who may benefit from it the most. We believe that by drawing on the strengths and complementarities of both companies, we will be able to do this even more effectively in the best interest of patients living with type 2 diabetes,” said Cyril Titeux, Vice President, Strategy and Organisation EMEA.
INVOKANA® (canagliflozin) is a member of a more recent class of drugs known as sodium glucose co-transporter 2 (SGLT2) inhibitors and was first approved in the European Union in November 2013. Canagliflozin is indicated for the treatment of adult patients with type 2 diabetes, to improve glycaemic control, where diet and exercise do not provide adequate glycaemic control either as monotherapy (when the use of metformin is contra-indicated or not suitable) or as add-on therapy.
VOKANAMET® (a fixed-dose combination of canagliflozin and metformin) is approved in the European Union to improve glycaemic control of adult patients with type 2 diabetes and, combines two oral glucose-lowering medicinal products with different and complementary mechanisms of action.
Healthcare professionals, patient advocacy representatives and employees at both companies are being informed about this exclusive distribution agreement in the concerned countries.
Although the time needed for the implementation of this distribution agreement and transfer of inventories may vary country by country, depending on local regulatory procedures, both companies are diligently working together to ensure a smooth transition with continued availability of the products for customers and patients who need them.
