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Janssen Pharmaceutica NV (“Janssen”) 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.
NOTES TO EDITORS
The European Economic Area (EEA) countries where INVOKANA® (canagliflozin) and VOKANAMET® (a fixed-dose combination of canagliflozin and metformin) currently have Pricing and Reimbursement Approvals are Austria, Belgium, Bulgaria, the Czech Republic, Denmark, Ireland, Italy, Luxemburg, the Netherlands, Poland, Slovakia, Sweden, Switzerland, and UK.
Additional EEA countries may be added to the territory covered by this exclusive distribution agreement pending termination of other existing distribution agreements such as in Greece, Malta and Cyprus, or after gaining Pricing and Reimbursement Approvals.
In 2013, INVOKANA® (canagliflozin) was approved in the European Union for the treatment of adults with type 2 diabetes mellitus (T2DM), to improve glycaemic control either as a monotherapy or add-on therapy. The European approval of canagliflozin was based on a comprehensive global Phase 3 clinical trial programme, which enrolled 10,285 patients in nine studies.1,2,3,4,5,6,7,8,9,10
INVOKANA® (canagliflozin) is a prescription medicine used alongside diet and exercise to lower blood sugar in adults with type 2 diabetes. INVOKANA® is not for people with type 1 diabetes or with diabetic ketoacidosis (increased ketones indicated in blood or urine). INVOKANA® is not licensed for children under 18 years of age. INVOKANA® does not have an indication for CV risk reduction.
Janssen Pharmaceuticals, Inc. and its affiliates have rights to canagliflozin through a license agreement with Mitsubishi Tanabe Pharma Corporation. Janssen Pharmaceuticals, Inc. and its affiliates have marketing rights in Africa, parts of Asia, Australia, Europe, the Middle East, New Zealand, North America and South America.
INVOKANA® is approved as a single agent in Aruba, Australia, Brazil, Canada, Chile, Colombia, Costa Rica, Curacao, Dominican Republic, El Salvador, the European Union (28 countries), Guatemala, Hong Kong, Iceland, India, Israel, Jamaica, Kazakhstan, Kuwait, Lebanon, Liechtenstein, Mexico, New Zealand, Nicaragua, Norway, Panama, Paraguay, Peru, Philippines, Qatar, Russia, Serbia, Singapore, South Korea, Switzerland, Thailand, United Arab Emirates and the United States.
About the Janssen Pharmaceutical Companies
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com/emea. Follow us on www.twitter.com/JanssenEMEA for our latest news.
Cautions Concerning Forward-Looking Statements
This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding distribution plans and availability of INVOKANA® and VOKANAMET®. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialise, actual results could vary materially from the expectations and projections of Janssen Pharmaceutica NV, any of the other Janssen Pharmaceutical Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behaviour and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended January 1, 2017, including under “Item 1A. Risk Factors,” its most recently filed Quarterly Report on Form 10-Q, including in the section captioned “Cautionary Note Regarding Forward-Looking Statements,” and the company's subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies and Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.
1 INVOKANA SmPC. Available at: http://ec.europa.eu/health/documents/community-register/2017/20170428137649/anx_137649_en.pdf
Last accessed August 2017
2 Lavalle-González FJ et al. Efficacy and safety of canagliflozin compared with placebo and sitagliptin in patients with type 2 diabetes on background metformin monotherapy: a randomised trial. Diabetologia. 2013;56(12):2582-92
3 Schernthaner G et al. Canagliflozin compared with sitagliptin for patients with type 2 diabetes who do not have adequate glycemic control with metformin plus sulfonylurea: a 52-week randomized trial. Diabetes Care. 2013; 36(9):2508-15
4 Cefalu WT et al. Efficacy and safety of canagliflozin versus glimepiride in patients with type 2 diabetes inadequately controlled with metformin (CANTATA-SU): 52 week results from a randomised, double-blind, phase 3 non-inferiority trial. Lancet. 2013; 382(9896):941-50
5 Bode B et al. Efficacy and safety of canagliflozin treatment in older subjects with type 2 diabetes mellitus: a randomized trial. Hosp Pract. 2013;41(2):72-84
6 Yale JF et al. Efficacy and safety of canagliflozin in subjects with type 2 diabetes and chronic kidney disease. Diabetes Obes Metab. 2013;15(5):463-73
7 Neal B, Perkovic V, et al. (2013). Rationale, design, and baseline characteristics of the Canagliflozin Cardiovascular Assessment Study (CANVAS)—a randomized placebo controlled trial. American Heart Journal; 166(2): 217-223
8 Stenlof et al. Efficacy and safety of canagliflozin monotherapy in subjects with type 2 diabetes mellitus inadequately controlled with diet and exercise. Diabetes Obes Metab. 2013;15(4):372-82
9 Wilding JP et al. Efficacy and safety of canagliflozin in patients with type 2 diabetes mellitus inadequately controlled with metformin and sulphonylurea: a randomised trial. Int J Clin Pract. 2013;67(12):1267-82
10 Forst T et al. Efficacy and Safety of Canagliflozin in subjects with Type 2 Diabetes on Metformin and Pioglitazone. Poster presented at the 4th World Congress on Controversies to Consensus in Diabetes, Obesity and Hypertension (CODHy), 2012; Nov.8-11; Barcelona, Spain, (P64).
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