VOKANAMET® (canagliflozin and immediate release metformin hydrochloride fixed dose combination) approved in the European Union

  VOKANAMET® (canagliflozin and immediate release metformin hydrochloride   fixed dose combination) approved in the European Union for treatment of   adults with type 2 diabetes [1]  Business Wire  BEERSE, Belgium -- April 25, 2014  Janssen-Cilag International NV (Janssen) announced today that the European Commission (EC) has approved VOKANAMET^® (a fixed-dose therapy combining canagliflozin and immediate release metformin hydrochloride in a single tablet) in the European Union, for the treatment of adults with type 2 diabetes mellitus to improve glycaemic control.^[1] Canagliflozin as a single agent was approved ^ as INVOKANA^® in the European Union in November 2013.^[2]  This EC decision follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), recommending the approval of canagliflozin and immediate release metformin hydrochloride fixed dose combination therapy, in February 2014. The combination therapy, which is taken as a single pill twice daily, is indicated in adults aged 18 years and older with type 2 diabetes mellitus to improve glycaemic control in:    *patients not adequately controlled on their maximally tolerated doses of     metformin alone;^[1]   *patients on their maximally tolerated doses of metformin along with other     glucose-lowering medicinal products including insulin, when these do not     provide adequate glycaemic control;^[1]   *patients already being treated with the combination of canagliflozin and     metformin as separate tablets;^[1]  Professor Guntram Schernthaner, Department of Medicine I, Rudolfstiftung Hospital, Austria comments, “The approval of VOKANAMET^® in the European Union is very welcome news for the growing number of people with type 2 diabetes in this region. Many patients struggle to achieve and maintain long-term glycaemic control, and the introduction of VOKANAMET^® provides added convenience to diabetes management, particularly to those patients who may benefit from two diabetes medications in one tablet.”  Commenting on the approval, Jane Griffiths, Company Group Chairman, Janssen Europe, Middle East, and Africa said, “We are delighted that the European Commission has approved VOKANAMET^® for use in the European Union, recognising the value and the convenience that this combined treatment option provides for patients. This approval further reinforces Janssen’s ongoing commitment to provide new therapeutic options that help to address unmet needs in the treatment of type 2 diabetes.”  The EC approval of this fixed-dose therapy combining canagliflozin and immediate release metformin hydrochloride in a single tablet taken twice daily was based on significant portions of the comprehensive global Phase 3 clinical development programme for canagliflozin single agent, including the studies with co-administration of metformin and canagliflozin as individual tablets.  The Phase 3 programme evaluated the safety and efficacy of canagliflozin across the spectrum of type 2 diabetes and included placebo and active comparator controlled studies. Three studies have compared canagliflozin to current standard treatments,^[3-5] two of which compared canagliflozin to sitagliptin as dual therapy with metformin and the other as triple therapy with metformin and sulphonylurea^[3,4]. In addition there is a study comparing canagliflozin to glimepiride as dual therapy with metformin.^[5] The Phase 3 programme also included two large studies in special populations:^[6-7] patients over age 55 with type 2 diabetes^[6] and patients with type 2 diabetes who were considered to be at high risk for cardiovascular disease.^[7]  Single agent canagliflozin (INVOKANA^®) was approved in the US in March 2013, and in the European Union, as well as Norway, Liechtenstein and Iceland in November 2013.^[2]  Canagliflozin is a member of a new class of drugs known as sodium glucose co-transporter 2 (SGLT2) inhibitors. SGLT2 inhibitors contribute to controlling blood glucose levels via the kidney. As glucose is filtered from the blood into the kidneys, it is reabsorbed back into the bloodstream. An important transport carrier in the renal proximal tubule responsible for this reabsorption is called sodium glucose co-transporter 2 (SGLT2). Canagliflozin selectively inhibits SGLT2, and, as a result, promotes the loss of glucose via the urine, lowering blood glucose levels in adults with type 2 diabetes. This mechanism of action is independent of insulin.^[2]  Metformin is a first-line pharmacotherapy that can be used alone or with other medications, including insulin, to treat type 2 diabetes. In people with type 2 diabetes, the liver overproduces glucose, which increases blood glucose levels. Metformin lowers blood glucose levels by decreasing the amount of glucose made by the liver, increasing insulin sensitivity in the muscle and delaying intestinal glucose absorption.^[8]  Janssen and its affiliates have rights to canagliflozin through a license agreement with Mitsubishi Tanabe Pharma Corporation. Janssen and its affiliates have marketing rights in North America, South America, Europe, the Middle East, Africa, Australia, New Zealand and parts of Asia.  About Type 2 Diabetes  Type 2 diabetes is a chronic condition that affects the body’s ability to metabolise sugar, or glucose, and is characterised by the inability of pancreatic beta cell function to keep up with the body’s demand for insulin.^[9]  The International Diabetes Federation estimates that, in 2013, 382 million people globally were living with diabetes (type 1 and 2), and this diabetes population is expected to grow to over 592 million by 2035. ^ In 2013, it was estimated that over 56 million people were living with diabetes in Europe.^[10] The World Health Organisation estimates that 90% of the diabetes population have type 2 diabetes.^[11]  If left uncontrolled, type 2 diabetes can lead to serious long-term microvascular and macrovascular complications. Improved glycemic control has been demonstrated to reduce the onset and progression of these complications.  About Janssen  The Janssen Pharmaceutical Companies of Johnson & Johnson are dedicated to addressing and solving the most important unmet medical needs of our time, including oncology, immunology, neuroscience, infectious disease, and cardiovascular and metabolic diseases. Driven by our commitment to patients, we develop innovative products, services and healthcare solutions to help people throughout the world.  More information can be found at www.janssen-emea.com  This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. 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 unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen-Cilag International NV and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: economic factors, such as interest rate and currency exchange rate fluctuations; competition, including technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; challenges to patents; changes in behavior and spending patterns or financial distress of purchasers of health care products and services; changes to governmental laws and regulations and domestic and foreign health care reforms; general industry conditions including trends toward health care cost containment; and increased scrutiny of the health care industry by government agencies. A further list and description 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 December 29, 2013, including in Exhibit 99 thereto, and our 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. Neither Janssen-Cilag International NV nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.                                       ###  1. European Commission http://ec.europa.eu/health/documents/community-register/html/newproc.htm#h Last accessed April 2014  2. INVOKANA SmPC. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-Summary_for_the_public/human/002649/WC500156455.pdf. Last accessed: April 2014  3. 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  4. 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  5. 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.  6. 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.  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. Glucophage Summary of Product Characteristics last updated on the eMC: 12/10/2010 http://www.medicines.org.uk/emc/medicine/1043. Last accessed: April 2014  9. International Diabetes Federation. About Diabetes. Available http://www.idf.org/about-diabetes. Last Accessed: April 2014  10. International Diabetes Federation.IDF Diabetes Atlas, 6th edn.Brussels, Belgium: International Diabetes Federation, 2013.http://www.idf.org/diabetesatlas. Last accessed April 2014  11. Definition, diagnosis and classification of diabetes mellitus and its complications. Part 1: Diagnosis and classification of diabetes mellitus. Geneva, World Health Organization, 1999 (WHO/NCD/NCS/99.2)  Contact:  Media contact: Brigitte Byl Europe Middle-East & Africa Phone: +32 (0)14 60 7172 or Investor contacts: Stan Panasewicz Phone: +1(732) 524-2524 or Louise Mehrotra Phone: +1(732) 524-6491