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Janssen Submits European Marketing Authorisation Application for Canagliflozin/Metformin Fixed-Dose Combination Therapy to Treat



  Janssen Submits European Marketing Authorisation Application for
  Canagliflozin/Metformin Fixed-Dose Combination Therapy to Treat Patients
  with Type 2 Diabetes

Business Wire

BEERSE, Belgium -- March 7, 2013

Janssen-Cilag International NV (Janssen) today announced it has submitted a
Marketing Authorisation Application (MAA) to the European Medicines Agency
(EMA) seeking approval for a fixed-dose therapy combining canagliflozin and
immediate release metformin to treat adult 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 in
the blood.^1 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.^2

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, increasing insulin sensitivity in the muscle and
delaying intestinal glucose absorption.^3

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 MAA are derived from the
comprehensive global Phase 3 clinical development programme for canagliflozin,
which were included in the MAA for canagliflozin submitted to the EMA on 26
June 2012. The canagliflozin Phase 3 programme represents the largest
late-stage development programme for an investigational pharmacologic product
for the treatment of patients with type 2 diabetes submitted to health
authorities to date.

The Phase 3 programme evaluated the safety and efficacy of canagliflozin
across the spectrum of type 2 diabetes and included placebo- and active
comparator-controlled studies. The programme 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 in 2012 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.

New Drug Applications (NDA) have also been submitted to the U.S. Food and Drug
Administration (FDA) for canagliflozin on May 31, 2012 and for a fixed-dose
therapy combining canagliflozin and immediate release metformin on December
12, 2012 for the treatment of adult patients with type 2 diabetes.

Janssen is confident in the value of the comprehensive clinical trial
programme of canagliflozin supporting the regulatory submissions to the EMA
and the FDA. However, the company cannot speculate on the outcome of these
regulatory procedures whilst they are ongoing.

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.^4

If left uncontrolled, type 2 diabetes can lead to serious long-term
microvascular and macrovascular complications such as coronary heart disease
(leading to heart attack) and stroke, 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.^4

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 www.janssen-emea.com

                                     ###

^1 Gerich J. Diabetes Med. 2010; 27: 136-42

^2 Rosenstock J. et al. Diabetes Care. 2012 Jun; 35(6):1232-8. doi:
10.2337/dc11-1926. Epub 2012 Apr 9

^3 Summary of Product Characteristics last updated on the eMC: 12/10/2010.
Available at: http://www.medicines.org.uk/emc/medicine/1043/spc. Last accessed
Feb 2013

^4 International Diabetes Federation. About Diabetes. Available
http://www.idf.org/about-diabetes. Last Accessed: Feb2013

Contact:

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