New and Long-Term Use Results for canagliflozin to be presented at European Association for the Study of Diabetes Annual

  New and Long-Term Use Results for canagliflozin to be presented at European
  Association for the Study of Diabetes Annual Meeting

    Latest results from 52- and 102-week analyses from the large clinical
development programme for canagliflozin add to the safety and efficacy profile
                            of the SGLT2 inhibitor

Business Wire

BEERSE, Belgium -- September 18, 2013

Janssen-Cilag International NV (Janssen) announced today that 12 presentations
on canagliflozin will be made at the upcoming annual meeting of the European
Association for the Study of Diabetes (EASD), from September 24-27 in
Barcelona, Spain.

The accepted abstracts include the first presentation of 52-week data results
from the Phase 3 trial DIA3002 evaluating canagliflozin compared to placebo in
adult patients with type 2 diabetes who are on a background therapy with
metformin and a sulfonylurea.

“We look forward to sharing the latest data for canagliflozin with the
scientific community at EASD,” said Norman Rosenthal, MD, FACE, FACP, Compound
Development Team Leader for canagliflozin at Janssen Research & Development,
LLC. “We believe the new analyses from our robust Phase 3 clinical programme
will provide a deeper understanding of canagliflozin and the approach of SGLT2
inhibition.”

In the European Union, canagliflozin is currently under consideration with the
European Medicines Agency (EMA). In the US, canagliflozin was approved with
the brand name INVOKANA™ in March 2013 by the U.S. Food and Drug
Administration for the treatment of adult patients with type 2 diabetes, and
is the first in a new class of medications called sodium glucose
co-transporter 2 (SGLT2) inhibitors available in the United States.

In total, 12 abstracts with results from the canagliflozin Phase 3 programme
will be presented at the 2013 annual meeting of the EASD; they are listed
below for reference. All times listed as Central European Summer Time (CEST).
The EASD program is available via the EASD Virtual Meeting. Please note that
all abstracts accepted for presentation at EASD are subject to the organisers’
embargo policies.

  *Poster session #073, “SGLT-2 clinical trials”, on Tuesday, September 24^th
    from 12:30 to 1:30 p.m.

       *Canagliflozin added on to dipeptidyl peptidase-4 inhibitors or
         glucagon-like peptide-1 agonists with or without other
         antihyperglycaemic agents in type 2 diabetes mellitus (results from
         DIA3008, abstract #933(Abstract #933)
       *Efficacy and safety of canagliflozin in subjects with type 2 diabetes
         mellitus inadequately controlled with metformin plus sulphonylurea
         over 52 weeks (results from DIA3002, abstract #934)
       *Efficacy and safety of canagliflozin monotherapy in subjects with
         type 2 diabetes mellitus inadequately controlled with diet and
         exercise over 52 weeks (results from DIA3005, abstract #935)

  *Poster session #079, “Novel approaches to treat type 1 and type 2
    diabetes”, on Tuesday, September 24^th from 12:30 to 1:30 p.m.

       *Effects of one-year treatment with canagliflozin or sitagliptin on
         glycaemic control and beta cell function measures in subjects with
         type 2 diabetes on metformin + sulfonylurea (results from DIA3015,
         abstract #993)

  *Poster session #074, “SGLT-2 inhibitors: influence on cardiovascular risk
    factors”, on Tuesday, September 24^th from 1:45 to 2:45 p.m.

       *Effects of canagliflozin on blood pressure and adverse events related
         to osmotic diuresis and reduced intravascular volume in subjects with
         type 2 diabetes mellitus (pooled analysis of Phase 3 studies,
         abstract #945)
       *Canagliflozin lowers HbA1c and blood pressure through weight
         loss-independent and weight loss-associated mechanisms (pooled
         analysis of Phase 3 studies, abstract #946)

  *Poster session #075, “SGLT-2 inhibitors: side effects, special
    populations”, on Wednesday, September 25^th from 12:30 to 1:30 p.m.

       *Urinary tract infection with canagliflozin in subjects with type 2
         diabetes mellitus (pooled analysis of Phase 3 studies, abstract #949)
       *Genital mycotic infections with canagliflozin in subjects with type 2
         diabetes mellitus (pooled analysis of Phase 3 studies, abstract #950)
       *Efficacy and safety of canagliflozin in subjects with type 2 diabetes
         mellitus and chronic kidney disease over 52 weeks (results from
         DIA3004, abstract #951)
       *Canagliflozin is effective and generally well tolerated in subjects
         with type 2 diabetes mellitus and Stage 3 chronic kidney disease
         (pooled analysis of Phase 3 studies, abstract #953)
       *Efficacy and safety of canagliflozin in older subjects with type 2
         diabetes mellitus (pooled analysis of Phase 3 studies, abstract
         #955(Abstract #955)

  *Oral presentation session #31, “Glucose down the drain”, on Thursday,
    September 26^th from 3:00 to 4:30 p.m.

       *Canagliflozin demonstrates durable glycaemic improvements over 104
         weeks compared with glimepiride in subjects with type 2 diabetes
         mellitus on metformin (results from DIA3009, abstract #182(Abstract
         #182)

Results from Phase 3 studies for canagliflozin have been published^1, 2, 3and
presented at the American Diabetes Association (ADA) Annual Scientific
Sessions inJune 2012 and June 2013, at the European Association for the Study
of Diabetes (EASD) Annual Meeting inOctober 2012, and at the World Congress
on Controversies to Consensus in Diabetes, Obesity, and Hypertension (CODHy)
inNovember 2012.

Janssen Pharmaceuticals, Inc. and its affiliates (Janssen) have rights to
canagliflozin through a license agreement with Mitsubishi Tanabe Pharma
Corporation. Janssen has marketing rights in North America, South America,
Europe, Middle East, Africa, Australia, New Zealand and parts of Asia.

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

                                     ###

References

^1Schernthaner G, Gross JL, Rosenstock J, Guarisco M, Fu M, Yee J, Kawaguchi
M, Canovatchel W, Meininger G. Canagliflozin Compared With Sitagliptin for
Patients With Type 2 Diabetes Who Do Not Have Adequate Glycemic Control With
Metformin Plus Sulfonylurea: A 52-week randomized trial. Diabetes Care. 2013
Apr 5. [Epub ahead of print]

^2Yale JF, Bakris G, Cariou B, Yue D, David-Neto E, Xi L, Figueroa K, Wajs E,
Usiskin K, Meininger G. Efficacy and safety of canagliflozin in subjects with
type 2 diabetes and chronic kidney disease. Diabetes Obes Metab. 2013
May;15(5):463-73.

^3Stenlöf K, Cefalu WT, Kim KA, Alba M, Usiskin K, Tong C, Canovatchel W,
Meininger G.Efficacy and safety of canagliflozin monotherapy in subjects with
type 2 diabetes mellitus inadequately controlled with diet and exercise.
Diabetes Obes Metab. 2013 Apr;15(4):372-82.

Contact:

Janssen
Europe Middle-East & Africa
Brigitte Byl
Phone: +3214607172
bbyl@its.jnj.com
or
Global
Christina Chan
Phone: + 1 (908) 927-5769
Mobile: +1 (908) 635-2406
cchan20@its.jnj.com
or
Investor contacts:
Stan Panasewicz
Phone: + 1 (732) 524-2524
Louise Mehrotra
Phone: + 1 (732) 524-6491