VOKANAMET® (canagliflozin and immediate release metformin hydrochloride fixed dose combination) approved in the European Union

  VOKANAMET® (canagliflozin and immediate release metformin hydrochloride
  fixed dose combination) approved in the European Union for treatment of
  adults with type 2 diabetes [1]

Business Wire

BEERSE, Belgium -- April 25, 2014

Janssen-Cilag International NV (Janssen) announced today that the European
Commission (EC) has approved VOKANAMET^® (a fixed-dose therapy combining
canagliflozin and immediate release metformin hydrochloride in a single
tablet) in the European Union, for the treatment of adults with type 2
diabetes mellitus to improve glycaemic control.^[1] Canagliflozin as a single
agent was approved ^ as INVOKANA^® in the European Union in November 2013.^[2]

This EC decision follows a positive opinion from the Committee for Medicinal
Products for Human Use (CHMP) of the European Medicines Agency (EMA),
recommending the approval of canagliflozin and immediate release metformin
hydrochloride fixed dose combination therapy, in February 2014. The
combination therapy, which is taken as a single pill twice daily, is indicated
in adults aged 18 years and older with type 2 diabetes mellitus to improve
glycaemic control in:

  *patients not adequately controlled on their maximally tolerated doses of
    metformin alone;^[1]
  *patients on their maximally tolerated doses of metformin along with other
    glucose-lowering medicinal products including insulin, when these do not
    provide adequate glycaemic control;^[1]
  *patients already being treated with the combination of canagliflozin and
    metformin as separate tablets;^[1]

Professor Guntram Schernthaner, Department of Medicine I, Rudolfstiftung
Hospital, Austria comments, “The approval of VOKANAMET^® in the European Union
is very welcome news for the growing number of people with type 2 diabetes in
this region. Many patients struggle to achieve and maintain long-term
glycaemic control, and the introduction of VOKANAMET^® provides added
convenience to diabetes management, particularly to those patients who may
benefit from two diabetes medications in one tablet.”

Commenting on the approval, Jane Griffiths, Company Group Chairman, Janssen
Europe, Middle East, and Africa said, “We are delighted that the European
Commission has approved VOKANAMET^® for use in the European Union, recognising
the value and the convenience that this combined treatment option provides for
patients. This approval further reinforces Janssen’s ongoing commitment to
provide new therapeutic options that help to address unmet needs in the
treatment of type 2 diabetes.”

The EC approval of this fixed-dose therapy combining canagliflozin and
immediate release metformin hydrochloride in a single tablet taken twice daily
was based on significant portions of the comprehensive global Phase 3 clinical
development programme for canagliflozin single agent, including the studies
with co-administration of metformin and canagliflozin as individual tablets.

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. Three studies have compared canagliflozin to
current standard treatments,^[3-5] two of which compared canagliflozin to
sitagliptin as dual therapy with metformin and the other as triple therapy
with metformin and sulphonylurea^[3,4]. In addition there is a study comparing
canagliflozin to glimepiride as dual therapy with metformin.^[5] The Phase 3
programme also included two large studies in special populations:^[6-7]
patients over age 55 with type 2 diabetes^[6] and patients with type 2
diabetes who were considered to be at high risk for cardiovascular
disease.^[7]

Single agent canagliflozin (INVOKANA^®) was approved in the US in March 2013,
and in the European Union, as well as Norway, Liechtenstein and Iceland in
November 2013.^[2]

Canagliflozin is a member of a new class of drugs known as sodium glucose
co-transporter 2 (SGLT2) inhibitors. SGLT2 inhibitors contribute to
controlling blood glucose levels via the kidney. As glucose is filtered from
the blood into the kidneys, it is reabsorbed back into the bloodstream. An
important transport carrier in the renal proximal tubule responsible for this
reabsorption is called sodium glucose co-transporter 2 (SGLT2). Canagliflozin
selectively inhibits SGLT2, and, as a result, promotes the loss of glucose via
the urine, lowering blood glucose levels in adults with type 2 diabetes. This
mechanism of action is independent of insulin.^[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.^[8]

Janssen and its affiliates have rights to canagliflozin through a license
agreement with Mitsubishi Tanabe Pharma Corporation. Janssen and its
affiliates have 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
metabolise sugar, or glucose, and is characterised by the inability of
pancreatic beta cell function to keep up with the body’s demand for
insulin.^[9]

The International Diabetes Federation estimates that, in 2013, 382 million
people globally were living with diabetes (type 1 and 2), and this diabetes
population is expected to grow to over 592 million by 2035. ^ In 2013, it was
estimated that over 56 million people were living with diabetes in
Europe.^[10] The World Health Organisation estimates that 90% of the diabetes
population have type 2 diabetes.^[11]

If left uncontrolled, type 2 diabetes can lead to serious long-term
microvascular and macrovascular complications. Improved glycemic control has
been demonstrated to reduce the onset and progression of these complications.

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

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-Cilag
International NV and/or Johnson & Johnson. Risks and uncertainties include,
but are not limited to: economic factors, such as interest rate and currency
exchange rate fluctuations; competition, including 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; general industry
conditions including 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 Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended
December 29, 2013, including in Exhibit 99 thereto, and our subsequent filings
with the Securities and Exchange Commission. Copies of these filings are
available online at www.sec.gov, www.jnj.com or on request from Johnson &
Johnson. Neither Janssen-Cilag International NV nor Johnson & Johnson
undertakes to update any forward-looking statement as a result of new
information or future events or developments.

                                     ###

1. European Commission
http://ec.europa.eu/health/documents/community-register/html/newproc.htm#h
Last accessed April 2014

2. INVOKANA SmPC. Available at:
http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-Summary_for_the_public/human/002649/WC500156455.pdf.
Last accessed: April 2014

3. Lavalle-González FJ et al. Efficacy and safety of canagliflozin compared
with placebo and sitagliptin in patients with type 2 diabetes on background
metformin monotherapy: a randomised trial. Diabetologia. 2013;56(12):2582-92

4. Schernthaner G et al. 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;
36(9):2508-15

5. Cefalu WT et al. Efficacy and safety of canagliflozin versus glimepiride in
patients with type 2 diabetes inadequately controlled with metformin
(CANTATA-SU): 52 week results from a randomised, double-blind, phase 3
non-inferiority trial. Lancet. 2013; 382(9896):941-50.

6. Bode B et al. Efficacy and safety of canagliflozin treatment in older
subjects with type 2 diabetes mellitus: a randomized trial. Hosp Pract.
2013;41(2):72-84.

7. Neal B, Perkovic V, et al. (2013). Rationale, design, and baseline
characteristics of the Canagliflozin Cardiovascular Assessment Study
(CANVAS)—A randomized placebo-controlled trial. American Heart Journal;
166(2): 217-223

8. Glucophage Summary of Product Characteristics last updated on the eMC:
12/10/2010 http://www.medicines.org.uk/emc/medicine/1043. Last accessed: April
2014

9. International Diabetes Federation. About Diabetes. Available
http://www.idf.org/about-diabetes. Last Accessed: April 2014

10. International Diabetes Federation.IDF Diabetes Atlas, 6th edn.Brussels,
Belgium: International Diabetes Federation,
2013.http://www.idf.org/diabetesatlas. Last accessed April 2014

11. Definition, diagnosis and classification of diabetes mellitus and its
complications. Part 1: Diagnosis and classification of diabetes mellitus.
Geneva, World Health Organization, 1999 (WHO/NCD/NCS/99.2)

Contact:

Media contact:
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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