Janssen Research & Development Submits New Drug Application to U.S. FDA for Canagliflozin/Metformin Fixed-Dose Combination Therapy to Treat Patients with Type 2 Diabetes

RARITAN, N.J., Dec. 12, 2012 /PRNewswire/ -- Janssen Research & Development, LLC (Janssen) today announced it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for a fixed-dose therapy combining canagliflozin and immediate release metformin to treat patients with type 2 diabetes.

Canagliflozin is an investigational, oral medication 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 people without diabetes, which may contribute to elevated glucose levels. Canagliflozin, a selective sodium glucose co-transporter 2 (SGLT2) inhibitor, blocks the reabsorption of glucose by the kidney, increasing glucose excretion and lowering blood glucose levels.

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.

If approved, this canagliflozin/metformin fixed-dose combination therapy could provide convenience for patients who may benefit from two diabetes medications working in one pill.

A significant portion of the clinical data in this NDA are derived from the comprehensive global Phase 3 clinical development program for canagliflozin, which were included in the NDA submitted to the FDA on May 31, 2012. The canagliflozin Phase 3 program represents the largest late-stage development program for an investigational pharmacologic product for the treatment of patients with type 2 diabetes submitted to health authorities to date.

The Phase 3 program evaluated the safety and efficacy of canagliflozin across the spectrum of type 2 diabetes and included placebo- and active comparator-controlled studies. The program also includes a study in patients who have or are at high risk for developing cardiovascular disease, called the CANagliflozin cardioVascular Assessment Study (CANVAS).

Janssen presented data from Phase 3 studies at the American Diabetes Association (ADA) in Philadelphia in June, at the European Association for the Study of Diabetes (EASD) in Berlin in October, and at the World Congress on Controversies to Consensus in Diabetes, Obesity, and Hypertension (CODHy) in Barcelona in November.

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, 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 metabolize sugar, or glucose, and is characterized by the inability of pancreatic beta cell function to keep up with the body's demand for insulin. 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. In most people with type 2 diabetes, obesity causes resistance of the body to the action of insulin and if the pancreatic beta cell cannot produce enough insulin, hyperglycemia and type 2 diabetes ensue.

If left uncontrolled, type 2 diabetes can lead to serious long-term microvascular complications such as nerve disease leading to amputation, retinopathy resulting in blindness and nephropathy causing end-stage renal disease. Improved glycemic control has been demonstrated to reduce the onset and progression of these complications.

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