Janssen Enters Exclusive Distribution Agreement for INVOKANA® and VOKANAMET® in Selected European Economic Area Countries
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).
Phone: +1 32 14-60-7172
Phone: +1 732-524-3922
Joseph J. Wolk
Phone: +1 732-524-1142
Om Business Wire
Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.
Følg saker fra Business Wire
Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.
Siste saker fra Business Wire
Madison Realty Capital Provides $64.0 Million Construction Financing for 200 Kent Avenue Development in Williamsburg, Brooklyn17.11.2017 16:20 | Pressemelding
Madison Realty Capital (MRC) announced the closing of a $64.0 million construction loan for 200 Kent Avenue, a 117,326 square foot mixed-use development located in Williamsburg, Brooklyn. The retail portion of the property, which will include over 600 feet of frontage, will be anchored by a popular national grocery chain. Overall, the project will offer 50,101 square feet of retail space, 22,055 square feet of office and restaurant space, and 45,170 square feet of parking. “We continue to establish MRC as the one-stop shop for financing transitional real estate, including ground-up development deals like 200 Kent Avenue,” said Josh Zegen, Co-Founder and Managing Principal of MRC. “In this case, we’re working with a repeat MRC borrower who understands our ability to execute efficiently, given our firm’s up-to-the minute knowledge of local market conditions and non-bureaucratic approach to
Ncardia Announces Completion of €10.5M Investment Round17.11.2017 12:31 | Pressemelding
Ncardia, an emerging drug discovery and development stem cell technology company whose mission is to deliver cardiac and neural solutions based on its best-in-class human induced pluripotent stem cell (iPSC)-derived technology, today announced the completion of a €10.5 million series B financing round. The round was led by Épimède, a Belgium venture capital firm. Ncardia is a privately-held company with operations in Europe and the US, that produces and commercializes high-quality, fully-functional human iPSC-derived cardiovascular and neuronal cell types. Using its cell products, Ncardia develops and commercializes assay services for drug safety and efficacy testing. Additionally the company has built up a strong portfolio of patents covering the use of stem cell models for these applications. Stefan Braam, CEO of Ncardia, commented: “At Ncardia, important progress h
Double Win for Vocalink at the 2017 Payments Awards17.11.2017 09:35 | Pressemelding
Vocalink, a Mastercard company, was last night awarded with two prestigious awards - The Overall Winner and the Payments Infrastructure of the Year Award, for its leading technology and expertise, and in recognition for a milestone year that saw Vocalink’s solutions transform the way people and businesses move money across the globe. 2017 saw Vocalink deliver ground-breaking immediate payments solutions both in the US and Thailand as well as enabling access to the UK payments industry through their payments gateway solution PayPort. The business also saw the launch of the new image based cheque clearing system, creating a robust and more efficient system in the UK. RTP ® in the US: This week, Vocalink announced the launch of RTP® (Real-Time Payments) in the US on behalf of The Clearing House; one of the most comprehensive real-tim
Envion AG: Start-up from the Heart of Berlin Has Pioneered Decentralized Mobile Mining by Combining Blockchain with Regenerative Energy17.11.2017 09:00 | Pressemelding
Envion AG has created a technology for the first truly mobile data-center that uses low-priced local energy to mine a broad spectrum of cryptocurrencies (Bitcoin, Ethereum, etc.). By harvesting locally available clean energy right at the source, envion can operate at lower costs than competitors and at the same time reduces the CO2 footprint of the blockchain industry. Envion aims at decentralizing the highly-concentrated mining market (China holds 80% in Bitcoin mining) and at bringing control of the market back to the users. That’s why envion gives 100% of its mining profits back to its community. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20171117005011/en/ Envion - World's Most Profitable Standard of Self-Expanding Crypto Infrastructure (Photo: Business Wire) Current challenges in the energy
Chugai's HEMLIBRA® Receives the World's First Regulatory Approval from FDA for Hemophilia A with Inhibitors16.11.2017 23:30 | Pressemelding
Chugai Pharmaceutical Co., Ltd. (TOKYO:4519) announced today that the U.S. Food and Drug Administration (FDA) has approved the bispecific antibody emicizumab (US product name: HEMLIBRA®) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients with hemophilia A (congenital factor VIII deficiency) with factor VIII inhibitors. This represents the first regulatory approval for HEMLIBRA® around the world. The US Biologics License Application (BLA) was submitted by Genentech, a member of Roche Group. “We are pleased that HEMLIBRA, a biopharmaceutical created by Chugai scientists based on their exceptional idea, has received its first regulatory approval,” said Chugai’s President & COO, Tatsuro Kosaka. “HEMLIBRA is a first in class biopharmaceutical which is an advancement on the current limited treatment options available for pat
Pacific Drilling Receives Approval of First Day Motions16.11.2017 22:08 | Pressemelding
Pacific Drilling S.A. (OTCPink: PACDQ) (“Pacific Drilling” or the “Company”) today announced that the United States Bankruptcy Court for the Southern District of New York has granted the relief requested by the Company in certain first day motions related to ordinary course business activities, subject to certain modifications at the request of the Court, the United States Trustee and stakeholders. The approved motions give us the authority to, among other things, continue to pay employee wages and benefits without interruption, to utilize our current cash management system, and to pay certain foreign and critical vendors for goods and services provided prior to the petition date. All vendors will be paid in full and in cash on normal payment terms for all goods and services provided on or after the petition date. Paul Reese, Chief Executive Officer of Pacific Drilling, said, “With the
I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.Besøk vårt presserom