Janssen Research & Development to Present Results from Five Phase 3 Studies Evaluating Investigational Canagliflozin for the Treatment of Type 2 Diabetes

RARITAN, N.J., June 5, 2012 /PRNewswire/ -- Janssen Research & Development, LLC (Janssen) announced today that data from five Phase 3 clinical studies evaluating the safety and efficacy of canagliflozin, an investigational sodium glucose co-transporter 2 (SLGT2) inhibitor, will be presented at the American Diabetes Association (ADA) 72nd Annual Scientific Sessions, being held June 8-12, in Philadelphia, PA.

Canagliflozin is an investigational SGLT2 inhibitor for the treatment of type 2 diabetes. The kidneys of people with type 2 diabetes reabsorb greater amounts of glucose back into the body compared with non-diabetic people, which may contribute to elevated glucose levels. Canagliflozin blocks the reabsorption of glucose by the kidney, increasing glucose excretion and lowering blood glucose levels.

The global Phase 3 canagliflozin clinical program enrolled more than 10,300 patients in nine studies, and is the largest late-stage development programs for an investigational pharmacologic product for the treatment of type 2 diabetes submitted to health authorities to date. The Phase 3 clinical program evaluated the safety and efficacy of canagliflozin across the spectrum of type 2 diabetes management, from adult patients treated only with diet and exercise to those requiring insulin injections to maintain glycemic control. The program also included three large studies in special populations: older patients with type 2 diabetes, patients with type 2 diabetes who had moderate renal impairment, and patients with type 2 diabetes who had or were at high risk for cardiovascular disease.

On May 31, 2012, Janssen submitted a New Drug Application to the U.S. Food and Drug Administration seeking approval for the use of canagliflozin as a treatment for adult patients with type 2 diabetes. Janssen and its affiliates have rights to canagliflozin through a license agreement with Mitsubishi Tanabe Pharma Corporation. Janssen Pharmaceuticals, Inc. has marketing rights in North America, South America, Europe, Middle East, Africa, Australia, New Zealand and parts of Asia.

The Phase 3 studies accepted for presentation at the 2012 ADA Scientific Sessions are (all times listed EDT):

• Late-Breaking Clinical Trial Poster Presentations of study results which will be presented on June 10 during the 12:00 – 2:00 p.m. session
  • Results from DIA3015, which evaluated canagliflozin compared to sitagliptin in adult patients with mild-to-moderate baseline hyperglycemia who were receiving maximal effective doses of metformin and sulfonylurea (SU), will be presented in the poster presentation "Efficacy and Safety of Canagliflozin, a Sodium Glucose Co-Transporter 2 Inhibitor, Compared with Sitagliptin in Patients with Type 2 Diabetes On Metformin Plus Sulfonylurea" (abstract 50-LB)
  • Results from DIA3009, which compared canagliflozin to glimepiride as add-on therapy in adult patients with inadequate glycemic control on maximal effective doses of metformin, will be presented in the poster presentation "Efficacy and Safety of Canagliflozin, a Sodium Glucose Co-Transporter 2 Inhibitor, Compared with Glimepiride in Patients with Type 2 Diabetes on Background Metformin" (abstract 38-LB)
  • Results from DIA3004, which evaluated canagliflozin as monotherapy in adult patients with moderate renal impairment and inadequate glycemic control with diet and exercise, will be presented in the poster presentation "Canagliflozin, a Sodium Glucose Co-Transporter 2 Inhibitor, Improves Glycemia and is Well Tolerated in Type 2 Diabetes Mellitus Subjects with Moderate Renal Impairment" (abstract 41-LB)

• Oral Presentations
  • Results from DIA3005, which evaluated the efficacy and safety of canagliflozin 100 mg or 300 mg versus placebo in adult patients with type 2 diabetes who are inadequately controlled with diet and exercise, will be presented in a session titled "Canagliflozin, a Sodium Glucose Co-Transporter 2 Inhibitor, Improves Glycemic Control and Lowers Body Weight in Subjects With Type 2 Diabetes Inadequately Controlled With Diet and Exercise" (abstract 81-OR) on June 9 from 2:45 – 3:00 p.m.

• Poster Presentations
  • Results from DIA3002, which evaluated the efficacy and safety of canagliflozin compared to placebo in adult patients with type 2 diabetes inadequately controlled with metformin and sulfonylurea, will be presented in poster presentation "Canagliflozin, a Sodium Glucose Co-Transporter 2 Inhibitor, Improves Glycemic Control and Reduces Body Weight in Subjects with Type 2 Diabetes Inadequately Controlled With Metformin and Sulfonylurea" (abstract 1022-P) on June 9, 11:30 a.m. – 12:30 p.m.
  • Additional results from DIA3005 in a poster presentation titled "Treatment with Canagliflozin, a Sodium Glucose Co-Transporter 2 Inhibitor, for 26 Weeks Improves Indices of Beta-cell Function" (abstract 1032-P) will be presented on June 9 from 11:30 a.m. – 12:30 p.m.

The Abstract Search and Itinerary Builder for the American Diabetes Association's Scientific Sessions is available online: http://www.abstractsonline.com/plan/start.aspx?mkey=%7B0F70410F-8DF3-49F5-A63D-3165359F5371%7D

"Janssen is committed to developing novel therapeutic options for the treatment of type 2 diabetes, and we are excited to present the first set of results from the global Phase 3 canagliflozin program at ADA," said Kirk Ways, M.D., Ph.D., Vice President of Clinical Development for canagliflozin at Janssen.

About Type 2 Diabetes

Type 2 diabetes is a chronic condition that affects the body's ability to metabolize sugar (glucose) and is characterized by the inability of beta cells in the pancreas to keep up with the body's demand for insulin. In most people with type 2 diabetes, obesity causes resistance to the action of insulin and if the pancreatic beta cells cannot produce enough insulin, high blood sugar levels (hyperglycemia) and type 2 diabetes ensue.

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 including nerve disease leading to amputation, retinopathy resulting in blindness and nephropathy causing end-stage renal disease.

About Janssen Research & Development, LLC

Janssen Research & Development, LLC is headquartered in Raritan, N.J. and has affiliated facilities in Europe, the United States and Asia. Janssen Research & Development is leveraging a combination of internal and external innovation to discover and develop novel medicines and solutions in five distinct therapeutic areas: Neuroscience, Oncology, Immunology, Infectious Diseases and Vaccines, and Cardiovascular and Metabolism. For more information about Janssen Research & Development, LLC visit www.janssenrnd.com.

Janssen Research & Development is part of the Janssen Pharmaceutical Companies of Johnson & Johnson. Driven by our commitment to patients, we work together to bring innovative ideas, products, services and solutions to address serious unmet medical needs around the world.

(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 Research & Development, LLC 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 www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Neither Janssen Research & Development, LLC nor Johnson & Johnson undertake to update any forward-looking statements as a result of new information or future events or developments.)

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SOURCE Janssen Research & Development, LLC