A. Menarini Farmaceutica Internazionale SRL (“Menarini”) has become the exclusive distributor for INVOKANA®(canagliflozin) and VOKANAMET®(a fixed-dose combination of canagliflozin and metformin) in the United Kingdom, including Northern Ireland, where the products have obtained Pricing and Reimbursement Approvals.
Menarini entered into an exclusive distribution agreement with manufacturer Janssen Pharmaceutica NV (“Janssen”) effective from January 2, 2023. Menarini has taken up the physical distribution as of July 1, 2023.
As a result of this agreement, Menarini becomes the exclusive distributor for the 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 Ltd, remains Marketing Authorisation Holder (MAH) in the concerned countries. 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 Menarini and its associated companies.
Francis Lynch, General Manager Ireland & UK, said: “At Menarini we are committed to providing the best possible outcomes for people with type 2 diabetes.
“We are working with Janssen to ensure a smooth transition with continued availability of these products for customers and patients who need them.”
Canagliflozin is a member of the 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.
A fixed-dose combination of canagliflozin and metformin is used 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.
A. Menarini Farmaceutica Internazionale SRL is the UK branch of the Menarini Group, Italy’s largest pharmaceutical company.
In the UK, it is also well-established in the areas of cardiology, anti-infectives and men’s sexual health.
Healthcare professionals, patient advocacy representatives and employees at Menarini and Janssen are being informed about this new exclusive distribution agreement in the concerned countries.
The companies are working together to ensure a smooth transition with continued availability of the products for customers and patients who need them.
July 2023 | PP-NP-UK-0006