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.
-ENDS-
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.
About canagliflozinIn 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
CompaniesAt 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 StatementsThis 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.
References:
1 INVOKANA SmPC. Available at:
http://ec.europa.eu/health/documents/community-register/2017/20170428137649/anx_137649_en.pdf
Last accessed August 20172 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):2582-923 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):2508-154 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):941-505 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):72-846 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):463-737 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): 217-2238 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):372-829 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):1267-8210 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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