JANSSEN

Janssen-Cilag International NV (Janssen) announced today that 10 presentations on INVOKANA^® (canagliflozin) will be made at the upcoming 50^th European Association for the Study of Diabetes (EASD) annual meeting, from 15^th -19^th September in Vienna, Austria.

“We look forward to sharing new data for canagliflozin at the upcoming 50 ^th EASD congress, which will provide a greater understanding of efficacy and safety across differing patient populations, alongside cost effectiveness analyses” said Thomas Stark, Vice-President Medical Affairs, Janssen EMEA. “The data which will be presented reinforce our continued commitment to provide innovative solutions for patients with type 2 diabetes and will provide a deeper knowledge of SGLT2 inhibition.”

The accepted abstracts include the first presentation of 52-week data results from the Phase 3 trial DIA3005, evaluating the mechanisms of body weight reduction with canagliflozin in adult patients with type 2 diabetes.

Canagliflozin is a member of a new class of drugs known as sodium glucose co-transporter 2 (SGLT2) inhibitors. It is an oral medication that reduces the reabsorption of glucose by the kidney, thereby promoting the loss of glucose in the urine and lowering blood glucose levels in adults with type 2 diabetes.¹ In November 2013, the European Commission approved canagliflozin in the European Union for the treatment of adults with type 2 diabetes mellitus, to improve glycaemic control.

In total, 10 abstracts for canagliflozin will be presented at the 2014, 50^th European Association for the Study of Diabetes annual meeting; they are listed below for reference. All times are listed as Central European Summer Time (CEST). The EASD programme is available via the EASD Virtual Meeting. Please note that all abstracts accepted for presentation at EASD are subject to the organisers’ embargo policies.

• Oral presentation 01: “SGLT2 inhibitors: new outcome studies” on Tuesday 16^th September 11:00-12:30
  • Long-term efficacy and safety of canagliflozin in older patients with type 2 diabetes mellitus over 104 weeks (results from DIA3010, abstract No. 5 )
• Poster session 062: “SGLT2 inhibitors: non-glycaemic endpoints” on Tuesday 16^th September 14:15 – 15:15
  • Predicted temporal changes in energy intake and energy expenditure in subjects with type 2 diabetes treated with canagliflozin (results from DIA3005, abstract No. 820 )
  • Impact of weight loss on weight-related quality of life and health satisfaction: evidence from a head-to-head study of canagliflozin vs. sitagliptin (results from DIA3006, abstract No. 826 )
  • The cost-effectiveness of canagliflozin versus sitagliptin as third-line therapy in the treatment of type 2 diabetes mellitus in the UK (results from DIA3015, abstract No. 817 )
• Poster session 065: “SGLT2 inhibitors: efficacy” on Thursday 18^th September 13:00 – 14:00
  • Glycaemic efficacy of canagliflozin is largely independent of baseline beta-cell function or insulin sensitivity (abstract No. 855 )
  • Glycaemic efficacy of canagliflozin by baseline HbA_1c and known duration of type 2 diabetes mellitus (abstract No. 847 )
  • Canagliflozin reduces both HbA1c and body weight in patients with type 2 diabetes mellitus on background metformin (abstract No. 854 )
  • Efficacy and safety of canagliflozin in patients with type 2 diabetes mellitus who were, or were not, on antihyperglycaemic agents at screening (abstract No. 853 )
• Poster session 060: “SGLT2 inhibitors: safety” on Thursday 18^th September 14:15 – 15:15
  • Efficacy and safety of canagliflozin in patients with type 2 diabetes mellitus who progressed to stage 3A chronic kidney disease during treatment (abstract No. 799 )

Janssen will also present an abstract relating to outcomes and costs associated with insulin and non-insulin therapies for type 2 diabetes, which does not include canagliflozin data:

• Poster session 090: “Individualised care” on Thursday 18^th September 14:15 – 15:15
  • Patient-reported outcomes and costs associated with insulin and non-insulin therapies for type 2 diabetes in five European countries (abstract No. 1072 )

About INVOKANA ^® (canagliflozin)

INVOKANA^® (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.¹

In November 2013, the European Commission approved INVOKANA^® (canagliflozin) in the European Union for the treatment of adults with type 2 diabetes mellitus, to improve glycaemic control.

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.²

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.³ The World Health Organisation estimates that 90% of the diabetes population has type 2 diabetes.⁴

If left uncontrolled, type 2 diabetes can lead to serious long-term microvascular and macrovascular complications. Improved glycaemic 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, Janssen develops 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.

No. No. No.

References

¹ INVOKANA SmPC. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002649/WC500156456.pdf . Last accessed: June 2014

² International Diabetes Federation. About Diabetes. Available http://www.idf.org/about-diabetes . Last Accessed: June 2014

³ International Diabetes Federation. IDF Diabetes Atlas, 6th edn.   Brussels, Belgium: International Diabetes Federation, 2013.  http://www.idf.org/diabetesatlas . Last accessed June 2014

⁴ World Health Organisation. Media Centre – Diabetes fact sheets. Available at: http://www.who.int/mediacentre/factsheets/fs312/en/ Last accessed July 2014

Contact:

Janssen
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
Phone: +1(732) 524-6491
Louise Mehrotra

Link:

ClickThru