U.S. FDA Approves INVOKANA™ (Canagliflozin) for the Treatment of Adults with Type 2 Diabetes

 U.S. FDA Approves INVOKANA™ (Canagliflozin) for the Treatment of Adults with
                               Type 2 Diabetes

INVOKANA™ is the first in a new class of type 2 diabetes medications available
in the United States

In Phase 3 studies, INVOKANA™ improved blood glucose control and was
associated with reductions in body weight and systolic blood pressure

Janssen will partner with other Johnson & Johnson companies focused on
diabetes to bring INVOKANA™ to healthcare professionals

PR Newswire

RARITAN, N.J., March 29, 2013

RARITAN, N.J., March 29, 2013 /PRNewswire/ -- Janssen Pharmaceuticals, Inc.
announced today the U.S. Food and Drug Administration (FDA) has approved
INVOKANA™ (canagliflozin) for the treatment of adults with type 2 diabetes.
INVOKANA™ is the first in a new class of medications called sodium glucose
co-transporter 2 (SGLT2)inhibitors to be approved in the United States. It is
also the only oral, once-daily medication available in the United States
offering improved glycemic control while also showing reduced body weight and
systolicblood pressure in clinical trials.

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"Patients with type 2 diabetes struggle managing their blood sugar, and nearly
half of adults with type 2 diabetes do not achieve recommended levels of
glucose control, increasing their risks for potentially life-threatening
complications," said Richard Aguilar*, M.D., Medical Director, Diabetes
Nation, LLC and Diabetes Care Foundation, a non-profit organization committed
to improving diabetes care. "INVOKANA™ is thought to work differently than
other currently-available medicines because it reduces blood glucose by acting
on the kidneys as a 'glucuretic,' increasing the loss of glucose in the urine.
What has historically been viewed as a sign of diabetes – glucose in the urine
– may also reflect the efficacy of a new and unique approach to treatment."

The kidneys make an important contribution to balancing blood glucose. As
glucose is filtered from the blood into the kidneys, it is reabsorbed back
into the bloodstream. An important carrier responsible for this reabsorption
is called sodium glucose co-transporter 2 (SGLT2). INVOKANA™ selectively
inhibits SGLT2, and as a result promotes the loss of glucose in the urine,
lowering blood glucose levels in adults with type 2 diabetes. 

"INVOKANA™ provides patients with type 2 diabetes the option of a once-daily
oral therapy that offers improved glycemic control and, in Phase 3 studies,
showed an incidence of hypoglycemia – low blood glucose – that was lower than
with glimepiride and similar to that of sitagliptin," said Jimmy Ren, Ph.D.,
Therapeutic Area Lead, Metabolics, Medical Affairs, Janssen Pharmaceuticals,
Inc. "In addition, this new treatment option is associated with reductions in
body weight and systolic blood pressure."

INVOKANA™ is indicated as an adjunct to diet and exercise to improve glycemic
control in adults with type 2 diabetes. INVOKANA™ has been studied as a single
agent (monotherapy), in combination with metformin, and in combination with
other glucose-lowering agents, including insulin, in patients who need further
glucose control. Results from the Phase 3 studies showed INVOKANA™ was
generally well tolerated. The most common adverse events with INVOKANA™ are
genital mycotic (fungal) infections, urinary tract infections, and increased
urination. These specific adverse events were generally mild to moderate in
intensity and infrequently led to discontinuation in Phase 3 studies. Overall
the rate of discontinuation due to adverse events was 4.3 percent for the
INVOKANA™ starting dose of 100 milligrams (mg), 3.6 percent for INVOKANA™ 300
mg and 3.1 percent versus competitors.

INVOKANA™ is an important addition to the comprehensive platform of offerings
for patients with diabetes from the Johnson & Johnson Family of Companies.
Janssen will partner with other Johnson & Johnson companies focused on
diabetes, such as LifeScan, Inc., and Animas Corporation, to bring INVOKANA™
to healthcare professionals treating patients with diabetes.

Janssen also will offer a dedicated INVOKANA™ CarePath support program to
patients and caregivers. The program provides important support and
information regarding affordable access, adherence and education, thereby
helping patients to start and appropriately manage their disease and therapy
over time.

"We are delighted with the approval of INVOKANA™ because it provides a
much-needed, new treatment option to help adults with type 2 diabetes and
their physicians manage this disease," said Kirk Ways, M.D., Ph.D.,
Development Head, Cardiovascular & Metabolism and Compound Development Team
Leader, Canagliflozin, Janssen Research & Development.

The new drug application for INVOKANA™ was based on a comprehensive global
Phase 3 clinical program, which enrolled 10,285 patients in nine studies and
is one of the largest clinical programs in type 2 diabetes submitted to health
authorities to date.

Results from this program showed that the 100 mg and the 300 mg doses of
INVOKANA™ improved glycemic control and, in prespecified secondary endpoints,
were associated with significant reductions in body weight and systolic blood
pressure. In two studies comparing INVOKANA™ to current standard treatments –
one studying sitagliptin and the other studying glimepiride – INVOKANA™ dosed
at 300 mg provided greater reductions in A1C levels and body weight than
either comparator. A1C is the percent of red blood cell hemoglobin with
glucose attached to it and an indicator of average blood glucose over the
previous two to three months. In the two studies, the overall incidence of
adverse events was similar with INVOKANA™ and the comparators.

In studies of INVOKANA™ as monotherapy or in combination with agents not
associated with hypoglycemia (such as metformin or metformin and
pioglitazone), the incidence of hypoglycemic episodes were less than 5 percent
across the groups (INVOKANA™ 100 mg [3.8 percent], INVOKANA™ 300 mg [4.3
percent], and placebo [2.2 percent]). There have been no clinical studies
establishing conclusive evidence of macrovascular risk reduction with
INVOKANA™ or any other antidiabetic medication. Additional data are being
collected to further characterize the cardiovascular profile of INVOKANA™.

The Phase 3 studies for INVOKANA™ were presented at the American Diabetes
Association (ADA) Annual Scientific Sessions in June 2012, at the European
Association for the Study of Diabetes (EASD) Annual Meeting in October 2012,
and at the World Congress on Controversies to Consensus in Diabetes, Obesity,
and Hypertension (CODHy) in November 2012.

Janssen and its affiliates have rights to INVOKANA™ through a license
agreement with Mitsubishi Tanabe Pharma Corporation. Janssen Pharmaceuticals,
Inc. 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

The U.S. Centers for Disease Control and Prevention estimates that nearly 26
million Americans have diabetes, 90 to 95 percent of which is 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.^1
U.S. national data from 2007 to 2010 show that nearly half of adults with type
2 diabetes were not achieving recommended levels of glucose control.^2

Approximately 60 percent of patients with type 2 diabetes in the United States
are obese, while another 30 percent are overweight. In most people at risk for
type 2 diabetes, obesity causes the body to resist 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 complications; improved glycemic control has been demonstrated to
reduce the onset and progression of these complications.^1

INDICATION STATEMENT

WHAT IS INVOKANA™?

  oINVOKANA™ is a prescription medicine used along with diet and exercise to
    lower blood sugar in adults with type2 diabetes.
  oINVOKANA™ is not for people with type1 diabetes.
  oINVOKANA™ is not for people with diabetic ketoacidosis (increased ketones
    in blood or urine).
  oIt is not known if INVOKANA™ is safe and effective in children under
    18years of age.

IMPORTANT SAFETY INFORMATION

WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT INVOKANA™?
INVOKANA™ can cause important side effects, including:

  oDehydration. INVOKANA™ can cause some people to have dehydration (the loss
    of body water and salt). Dehydration may cause you to feel dizzy, faint,
    lightheaded, or weak, especially when you stand up (orthostatic
    hypotension).

You may be at higher risk of dehydration if you:

     ohave low blood pressure
     otake medicines to lower your blood pressure, including diuretics (water
       pill)
     oare on low sodium (salt) diet
     ohave kidney problems
     oare 65 years of age or older

  oVaginal yeast infection. Women who take INVOKANA™ may get vaginal yeast
    infections. Symptoms of a vaginal yeast infection include:

       ovaginal odor
       owhite or yellowish vaginal discharge (discharge may be lumpy or look
         like cottage cheese)
       ovaginal itching

  oYeast infection of the penis (balanitis or balanoposthitis). Men who take
    INVOKANA™ may get a yeast infection of the skin around the penis. Certain
    men who are not circumcised may have swelling of the penis that makes it
    difficult to pull back the skin around the tip of the penis. Other
    symptoms of yeast infection of the penis include:

       oredness, itching, or swelling of the penis
       orash of the penis
       ofoul smelling discharge from the penis
       opain in the skin around penis

Talk to your doctor about what to do if you get symptoms of a yeast infection
of the vagina or penis. Your doctor may suggest you use an over-the-counter
antifungal medicine. Talk to your doctor right away if you use an
over-the-counter antifungal medication and your symptoms do not go away.

WHO SHOULD NOT TAKE INVOKANA™?
Do not take INVOKANA™ if you:

  oare allergic to canagliflozin or any of the ingredients in INVOKANA™. See
    the end of the Medication Guide for a list of ingredients in INVOKANA™.
    Symptoms of allergic reaction to INVOKANA™ may include:

       orash
       oraised red patches on your skin (hives)
       oswelling of the face, lips, tongue, and throat that may cause
         difficulty in breathing or swallowing

  ohave severe kidney problems or are on dialysis

WHAT SHOULD I TELL MY DOCTOR BEFORE TAKING INVOKANA™?
Before you take INVOKANA™, tell your doctor if you:

  ohave kidney problems
  ohave liver problems
  oare on a low sodium (salt) diet. Your doctor may change your diet or your
    dose of INVOKANA™.
  ohave ever had an allergic reaction to INVOKANA™
  ohave other medical conditions
  oare pregnant or plan to become pregnant. It is not known if INVOKANA™ will
    harm your unborn baby. If you are pregnant, talk with your doctor about
    the best way to control your blood sugar while you are pregnant.
  oare breastfeeding or plan to breastfeed. It is not known if INVOKANA™
    passes into your breast milk. Talk with your doctor about the best way to
    feed your baby if you are taking INVOKANA™.

Tell your doctor about all the medicines you take, including prescription and
non-prescription medicines, vitamins, and herbal supplements.

INVOKANA™ may affect the way other medicines work, and other medicines may
affect how INVOKANA™ works. Especially tell your doctor if you take:

  odiuretics (water pills)
  orifampin (used to treat or prevent tuberculosis)
  ophenytoin or phenobarbital (used to control seizures)
  oritonavir (Norvir®, Kaletra®, Lopinavir ^ ®)* (used to treat HIV
    infection)
  odigoxin (Lanoxin®)* (used to treat heart problems)

Ask your doctor or pharmacist for a list of these medicines if you are not
sure if your medicine is listed above.

Know the medicines you take. Keep a list of them and show it to your doctor
and pharmacist when you get a new medicine.

HOW SHOULD I TAKE INVOKANA™?

  oTake INVOKANA™ by mouth 1time each day exactly as your doctor tells you
    to take it.
  oYour doctor will tell you how much INVOKANA™ to take and when to take it.
    Your doctor may change your dose if needed.
  oIt is best to take INVOKANA™ before the first meal of the day.
  oYour doctor may tell you to take INVOKANA™ along with other diabetes
    medicines. Low blood sugar can happen more often when INVOKANA™ is taken
    with certain other diabetes medicines. See "What are the possible side
    effects of INVOKANA™?"
  oIf you miss a dose, take it as soon as you remember. If it is almost time
    for your next dose, skip the missed dose and take the medicine at the next
    regularly scheduled time. Do not take two doses of INVOKANA™ at the same
    time. Talk to your doctor if you have questions about a missed dose.
  oIf you take too much INVOKANA™, call your doctor or go to the nearest
    hospital emergency room right away. When your body is under some types of
    stress, such as fever, trauma (such as a car accident), infection, or
    surgery, the amount of diabetes medicine you need may change. Tell your
    doctor right away if you have any of these conditions and follow your
    doctor's instructions.
  oStay on your prescribed diet and exercise program while taking INVOKANA™.
  oCheck your blood sugar as your doctor tells you to.
  oINVOKANA™ will cause your urine to test positive for glucose.
  oYour doctor may do certain blood tests before you start INVOKANA™ and
    during treatment as needed. Your doctor may change your dose of INVOKANA™
    based on the results of your blood tests.
  oYour doctor will check your diabetes with regular blood tests, including
    your blood sugar levels and your hemoglobin A1C.

WHAT ARE THE POSSIBLE SIDE EFFECTS OF INVOKANA™?
INVOKANA™ may cause serious side effects, including:
See "What is the most important information I should know about INVOKANA™?"

  okidney problems
  oa high amount of potassium in your blood (hyperkalemia)
  olow blood sugar (hypoglycemia). If you take INVOKANA™ with another
    medicine that can cause low blood sugar, such as a sulfonylurea or
    insulin, your risk of getting low blood sugar is higher. The dose of your
    sulfonylurea medicine or insulin may need to be lowered while you take
    INVOKANA™.

Signs and symptoms of low blood sugar may include:

  oheadache
  odrowsiness
  oweakness
  odizziness
  oconfusion
  oirritability
  ohunger
  ofast heart-beat
  osweating
  oshaking or feeling jittery
  oserious allergic reaction. If you have any symptoms of a serious allergic
    reaction, stop taking INVOKANA™ and call your doctor right away or go to
    the nearest hospital emergency room. See "Who should not take
    INVOKANA™?". Your doctor may give you a medicine for your allergic
    reaction and prescribe a different medicine for your diabetes.

The most common side effects of INVOKANA™ include:

  ovaginal yeast infections and yeast infections of the penis (See "What is
    the most important information I should know about INVOKANA™?")
  ourinary tract infection
  ochanges in urination, including urgent need to urinate more often, in
    larger amounts, or at night

Tell your doctor if you have any side effect that bothers you or that does not
go away. These are not all the possible side effects of INVOKANA™. For more
information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side
effects to FDA at 1-800-FDA-1088.

You may also report side effects to Janssen Scientific Affairs, LLC at
1-800-526-7736.

Please see full Prescribing Information and Medication Guide.

Trademarks are those of their respective owners.

K02CAN13050

About Janssen Pharmaceuticals, Inc.
As a member of the Janssen Pharmaceutical Companies of Johnson & Johnson,
Janssen Pharmaceuticals, Inc. is dedicated to addressing and resolving the
major unmet medical needs of our time. Driven by our commitment to patients,
healthcare professionals, and caregivers, we strive to develop sustainable and
integrated healthcare solutions by working in partnership with all
stakeholders on the basis of trust and transparency. Our daily work is guided
by meeting goals of excellence in quality, innovation, safety, and efficacy in
order to advance patient care.

Our company provides medicines for an array of illnesses and disorders in
several therapeutic areas. Other innovative therapies that Janssen
Pharmaceuticals, Inc. offers include ACIPHEX^® (rabeprazole sodium), ELMIRON^®
(pentosan polysulfate sodium), INVEGA^® SUSTENNA^® (paliperidone palmitate)
extended-release injectable suspension, NUCYNTA^® ER (tapentadol
extended-release tablets), RISPERDAL^® CONSTA^® (risperidone) Long-Acting
Injection and XARELTO^® (rivaroxaban). The full prescribing information for
INVEGA^® SUSTENNA^®, NUCYNTA^® ER and RISPERDAL^® CONSTA^® and XARELTO^®,
including boxed warnings, are available here, here, here, and here.

For more information on Janssen Pharmaceuticals, Inc., visit us at
www.janssenpharmaceuticalsinc.com or follow us on Twitter at
www.twitter.com/JanssenUS and on YouTube at www.Youtube.com/JanssenUS.

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
Pharmaceuticals, Inc. 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 December 30, 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 Pharmaceuticals, Inc.
nor Johnson & Johnson undertake to update any forward-looking statements as a
result of new information or future events or developments.

*Dr. Aguilar was not associated with the INVOKANA™ clinical trials and was not
compensated for any media work. He has been a paid consultant to Janssen
Pharmaceuticals, Inc.

References

^1Centers for Disease Control and Prevention. National diabetes fact sheet:
national estimates and general information on diabetes and prediabetes in the
United States, 2011. Atlanta, GA: U.S. Department of Health and Human
Services, Centers for Disease Control and Prevention, 2011. Available at:
http://www.diabetes.org/in-my-community/local-offices/miami-florida/assets/files/national-diabetes-fact-sheet.pdf.
Accessed January 28, 2013.
^2Casagrande SS, Fradkin JE, Saydah SH, Rust KF, Cowie CC. The prevalence of
meeting A1C, blood pressure, and LDL goals among people with diabetes,
1988–2010. Diabetes Care. 2013 Feb 15. Epub ahead of print.

SOURCE Janssen Pharmaceuticals, Inc.

Website: http://www.janssenpharmaceuticalsinc.com
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