Breaking News

Tweet TWEET

Janssen Research & Development Submits New Drug Application to U.S. FDA for Canagliflozin/Metformin Fixed-Dose Combination

 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

PR Newswire

RARITAN, N.J., Dec. 12, 2012

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 theNDA 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.)

Media contacts:
Ernie Knewitz
Phone: (908) 927-2953
eknewitz@its.jnj.com

Christina Chan
Phone: (908) 927-5769
cchan20@its.jnj.com

Investor contacts:
Stan Panasewicz
Phone: (732) 524-2524

Louise Mehrotra
Phone: (732) 524-6491

SOURCE Janssen Research & Development, LLC

Website: http://www.janssenrnd.com
 
Press spacebar to pause and continue. Press esc to stop.