Mundipharma licensed by Janssen Pharmaceutica NV to market Invokana (canagliflozin) and Vokanamet (canagliflozin + metformin) for type 2 diabetes in EEA and Switzerland.- Janssen Pharmaceutica NV.

The Mundipharma network of independent associated companies has entered into an exclusive distribution agreement with Janssen Pharmaceutica NV for primary care type 2 diabetes medicines Invokana (canagliflozin) and Vokanamet (a fixed-dose combination therapy of canagliflozin and metformin). The agreement includes all countries in the European Economic Area (EEA) and Switzerland where the products have obtained price and reimbursement approvals. Invokana (canagliflozin) is a member of a novel class of drugs known as sodium glucose cotransporter 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.

Under the distribution agreement, the responsibility for the sale, marketing and promotion of both products will transfer to Mundipharma in 14 of the 17 European markets where Janssen has already secured reimbursement, with the additional three to be included in the coming months.

If Janssen obtains pricing and reimbursement for the Products in other countries, Mundipharma may elect to have such countries added to the Agreement. Janssen�s affiliate, Janssen-Cilag International NV, remains Marketing Authorisation Holder (MAH) in the concerned countries (except that JanssenCilag AG remains MAH for Switzerland). Janssen maintains manufacturing responsibilities and will continue to be responsible for certain regulatory activities including pharmacovigilance and Marketing Authorisation updates in close collaboration with Mundipharma.

The European Economic Area (EEA) countries, as well as Switzerland, where Invokana (canagliflozin) and Vokanamet (a fixed-dose combination of canagliflozin & metformin) currently have pricing and reimbursement approvals are: UK, Ireland, Belgium, Bulgaria, the Netherlands, Luxemburg, Denmark, Sweden, Italy, Austria, the Czech Republic, Poland, and Slovakia.