Janssen-Cilag International NV (Janssen)

Janssen Submits European Marketing Authorisation Application for Canagliflozin in Type 2 Diabetes

Beerse, Belgium (ots/PRNewswire) - Janssen-Cilag International NV (Janssen) announced today that it has submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for the use of canagliflozin, an investigational, oral, once-daily sodium glucose co-transporter 2 (SGLT2) inhibitor, for the treatment of adult patients with type 2 diabetes.

The MAA submission for canagliflozin is supported by a comprehensive global Phase III clinical development programme, which included nine multicentre, randomised clinical studies that enrolled approximately 10,300 patients, representing the largest late-stage development programme for an investigational pharmacologic product for the treatment of adult patients with type 2 diabetes submitted to health authorities to date. The Phase III programme evaluated the safety and efficacy of canagliflozin across the spectrum of adult patients with type 2 diabetes and included placebo- and active comparator-controlled studies.[1] The programme also included a dedicated cardiovascular study conducted in patients who have or are at high risk for developing cardiovascular disease. Janssen has presented and will continue to present data from the Phase III studies at scientific meetings.[i,ii,iii,iv,v,vi,vii,viii] On May 31, 2012 Janssen also submitted a New Drug Application for canagliflozin to the Food and Drug Administration (FDA) for a similar indication.

Canagliflozin is an investigational, oral, once-daily sodium glucose co-transporter 2 (SGLT2) inhibitor for the treatment of adult patients with type 2 diabetes. The kidneys of people with type 2 diabetes reabsorb greater amounts of glucose back into the body compared to non-diabetic people, which may contribute to elevated glucose levels. Canagliflozin has been shown to block the reabsorption of glucose by the kidney, increasing glucose excretion and lowering blood glucose levels.[i,ix,x,xi,xii,xiii]

Janssen 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 North America, South America, Europe, Middle East, Africa, Australia, New Zealand and parts of Asia.

Janssen is confident in the value of the comprehensive clinical trial programme of canagliflozin supporting the MAA to the EMA. However, the company cannot speculate on the outcome of this regulatory procedure whilst it is ongoing.

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.[xiv] If left uncontrolled, type 2 diabetes can lead to serious long-term complications such as macrovascular disease (myocardial infarctions, strokes, peripheral vascular disease) and microvascular disease such as neuropathy leading to amputation, retinopathy resulting in blindness and nephropathy causing end-stage renal disease.[xv]

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 http://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 materialise, actual results could vary materially from the expectations and projections of Janssen-Cilag International NV, any of the other Janssen Pharmaceutical Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to, general industry conditions and competition; economic factors, such as interest rate and currency exchange rate fluctuations; 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; 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 Exhibit 99 of Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended January 1, 2012. Copies of this Form 10-K, as well as subsequent filings, are available online at http://www.sec.gov, http://www.jnj.com or on request from Johnson & Johnson. The Janssen Pharmaceutical Companies and Johnson & Johnson do not undertake to update any forward-looking statements as a result of new information or future events or developments.)

References

1. The results of key Phase III studies were presented at the 72nd American Diabetes Association (ADA) Annual Scientific Sessions

http://www.prnewswire.co.uk/news-releases/canagliflozin-provided- sustained-glycemic-improvements-as-monotherapy-and-in-add-on-combinat ions-in-adults-with-type-2-diabetes-in-five-phase-3-clinical-studies- 158296585.html

i. Stenlöf K et al. Abstract No: 81-OR. Abstract presented at the 72nd Scientific Sessions of the American Diabetes Association. 2012; June 8-12: Philadelphia, USA.

ii. Wilding E et al. Abstract No: 1022-P. Abstract presented at the 72nd Scientific Sessions of the American Diabetes Association. 2012; June 8-12: Philadelphia, USA.

iii. Yale J-F et al. Abstract No: 41-LB. Abstract presented at the 72nd Scientific Sessions of the American Diabetes Association. 2012; June 8-12: Philadelphia, USA.

iv. Cefalu W et al. Abstract No: 38-LB. Abstract presented at the 72nd Scientific Sessions of the American Diabetes Association. 2012; June 8-12: Philadelphia, USA.

v. Schernthaner G et al. Abstract No: 50-LB. Abstract presented at the 72nd Scientific Sessions of the American Diabetes Association. 2012; June 8-12: Philadelphia, USA.

vi. Ferrannini E et al. Abstract No: 1032-P. Abstract presented at the 72nd Scientific Sessions of the American Diabetes Association. 2012; June 8-12: Philadelphia, USA.

vii. Polidori D et al. Abstract No: 79-OR. Abstract presented at the 72nd Scientific Sessions of the American Diabetes Association. 2012; June 8-12: Philadelphia, USA.

viii. Stein P et al. Abstract No: 84-OR. Abstract presented at the 72nd Scientific Sessions of the American Diabetes Association. 2012; June 8-12: Philadelphia, USA.

ix. Nomura S et al. J. Med. Chem. 2010;53:6355-6360.

x. Sha S et al. Diabetes, Obesity and Metabolism. 2011 July; 13(7): 669-672.

xi. Liang Y et al. PLoS One. 2012 February;7(2):e30555.

xii. Rosenstock J et al. Diabetes Care. Diabetes Care. 2012 Jun;35(6):1232-1238.

xiii. Polidori D et al. Abstract No: D-0992. Abstract presented at the 11th International Diabetes Federation World Diabetes Congress. 2011; December 4-8 2011: Dubai.

xiv. DeFronzo R. Am J. Med. 2010 Mar;123(3 Suppl):S38-48

xv. Inzucchi S et al. Diabetologia. 2012 Jun;55(6):1577-96

Contact:

Media contacts: Europe Middle-East & Africa: Brigitte Byl, Phone:
+32(0)14-60-7172; Investor contacts: Stan Panasewicz, Phone:
+1-(732)-524-2524; Louise Mehrotra, Phone: +1-(732)-524-6491


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