Latest Data for Type 2 Diabetes Treatment INVOKANA™ (canagliflozin) to be Presented at American Diabetes Association Annual

  Latest Data for Type 2 Diabetes Treatment INVOKANA™ (canagliflozin) to be
          Presented at American Diabetes Association Annual Meeting

Late-Breaking Phase 3 Results and Health Economics Data are Among 17 Accepted

Note: This release corresponds to ADA abstracts 65-LB, 73-LB, 76-LB, 238-OR,
239-OR, 522-P, 1069-P, 1075-P, 1077-P, 1080-P, 1084-P, 1098-P, 1110-P, 1122-P,
1124-P, 1139-P, 1164-P, 1232-P, 1243-P, 1254-P, 1259-P, 1283-P, and 1565-P.

PR Newswire

RARITAN, N.J., June 18, 2013

RARITAN, N.J., June 18, 2013 /PRNewswire/ --Janssen Research & Development,
LLC (Janssen) announced today that 17 presentations on INVOKANA™
(canagliflozin) ― including Phase 3 clinical safety and efficacy data, and a
health economic analysis ― will be made at the American Diabetes Association
(ADA) 73^rd Annual Scientific Sessions, June 21-25, in Chicago, Ill.

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
systolic blood pressure in clinical trials.

The 17 INVOKANA™ presentations at the meeting will include three late-breaking
abstracts and the first presentation of results from the Phase 3 trial
(DIA3006) evaluating INVOKANA™ compared to sitagliptin in adult patients who
were on a background of metformin therapy.

"We continue to develop INVOKANA™ for the treatment of type 2 diabetes, and
are pleased to share the latest results at the upcoming ADA meeting," said
Kirk Ways, M.D., Ph.D., Vice President of Cardiovascular/Metabolism Clinical
Development at Janssen. "Also, we are looking forward to sharing healthcare
economics and outcomes data that can help illustrate the disease burden and
patient experience of living with type 2 diabetes."

The abstracts for INVOKANA™ accepted for presentation at the 2013 ADA
Scientific Sessions include (all times listed CDT):

Late-breaking Clinical Phase 3

  o"Canagliflozin Demonstrates Durable Glycemic Improvements Over 104 Weeks
    Versus Glimepiride in Subjects With Type 2 Diabetes Mellitus on Metformin"
    (results from DIA3009; abstract 65-LB)
  o"Efficacy and Safety of Canagliflozin in Older Subjects with Type 2
    Diabetes Mellitus" (abstract 76-LB)
  o"Canagliflozin is Effective and Generally Well Tolerated in Subjects with
    Type 2 Diabetes Mellitus and Stage 3 Chronic Kidney Disease" (abstract

Clinical Phase 3
Oral presentation on Sunday, June 23^rd during the 4:30-6:30 PM session

  o"Canagliflozin Compared with Sitagliptin in Subjects with Type 2 Diabetes
    Mellitus on Metformin Over 52 Weeks" (abstract 238-OR).

Posters to be presented on Sunday, June 23^rd during the 12:00-2:00 PM session

  o"Efficacy and Safety of Canagliflozin in Subjects with Type 2 Diabetes
    Mellitus on Metformin and Pioglitazone Over 52 Weeks" (results from
    DIA3012; abstract 1098-P)
  o"Efficacy and Safety of Canagliflozin Monotherapy in Subjects with Type 2
    Diabetes Mellitus Over 52 Weeks" (results from DIA3005; abstract 1164-P)
  o"Efficacy and Safety of Canagliflozin in Subjects with Type 2 Diabetes
    Mellitus and Chronic Kidney Disease Over 52 Weeks" (results from DIA3004;
    abstract 1075-P)
  o"Canagliflozin in Subjects with Type 2 Diabetes Mellitus Inadequately
    Controlled on Sulfonylurea Monotherapy: A CANVAS substudy" (results from
    DIA3008, or CANVAS, sulfonylurea substudy; abstract 1124-P)
  o"Effects of Canagliflozin Added on to Basal Insulin Plus or Minus Other
    Antihyperglycemic Agents in Type 2 Diabetes" (results from DIA3008,
    insulin substudy and add-on to basal insulin post hoc; abstract 1084-P)
  o"Canagliflozin Added on to DPP-4i or GLP-1 Agonists With or Without Other
    Antihyperglycemic Agents in Type 2 Diabetes Mellitus" (results from
    DIA3008, add-on to DPP-4i, GLP-1a post hoc; abstract 1080-P)
  o"Genital Mycotic Infections with Canagliflozin in Subjects with Type 2
    Diabetes Mellitus" (abstract 1069-P)
  o"Urinary Tract Infection with Canagliflozin in Subjects with Type 2
    Diabetes Mellitus" (abstract 1139-P)
  o"Canagliflozin Lowers A1C and Blood Pressure Through Weight
    Loss-Independent and Weight Loss-Associated Mechanisms" (abstract 1110-P)
  o"Lower Blood Pressure with Canagliflozin in Subjects with Type 2 Diabetes
    Mellitus" (abstract 1077-P)

Preclinical and Clinical Phase 1
Oral presentation on Sunday, June 23^rd during the 4:30-6:30 PM session

  o"In Vitro Characterization of the Selective Sodium Glucose Co-Transporter
    2 Inhibitor Canagliflozin" (abstract 239-OR)

Poster to be presented on Sunday, June 23^rd during the 12:00-2:00 PM session

  o"Effect of Canagliflozin 300 mg on C-peptide Clearance" (results from
    DIA1049; abstract 1122-P)

Health Care Delivery and Economics
Poster to be presented on Sunday, June 23^rd during the 12:00-2:00 PM session

  o"A Health Economic Analysis of the Long-term Benefits and Associated Cost
    Offsets of Canagliflozin Monotherapy in the U.S." (abstract 1232-P)

Also Relevant to INVOKANA™
Posters to be presented on Sunday, June 23^rd during the 12:00-2:00 PM session

  o"Correlation Between Hypoglycemia and Adherence With Oral
    Antihyperglycemic Agents In Patients With Type 2 Diabetes" (results from a
    National Health Wellness Survey; abstract 1259-P)
  o"Patient Reported Perspectives on Diabetes Disease, Comorbidities, Glucose
    Control, and Adherence" (results from a National Health Wellness Survey;
    abstract 1283-P)
  o"Type 2 Diabetes Mellitus Patients Who Are Trying to Lose Weight:
    Satisfaction With Oral Antihyperglycemic Agents" (results from a National
    Health Wellness Survey; abstract 1243-P)
  o"Vulvovaginal Candidiasis and Urinary Tract Infection in Women With and
    Without Type 2 Diabetes Mellitus" (abstract 1254-P)
  o"What fraction of type 2 diabetics in the United States meet the
    recommended levels of HDL cholesterol, one half or two thirds?" (abstract

Poster to be presented on Saturday, June 22^nd during the 11:30 AM - 1:30 PM

  o"SGLT2 Inhibition Prevents the Development of Nephropathy in Diabetic
    Mice" (abstract 522-P)

Abstracts of all accepted presentations are available on the ADA Abstract
Search and Itinerary Builder by visiting:

INVOKANA™ acts on the kidneys, which 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; SGLT2 is an important
carrier responsible for this reabsorption, and appears to be elevated in
people with type 2 diabetes, contributing to high levels of blood
glucose.INVOKANA™ selectively inhibits SGLT2, promoting the loss of glucose
in the urine and lowering blood glucose levels in adults with type 2 diabetes.

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

About Type 2 Diabetes
According to the International Diabetes Federation, 371 million worldwide are
living with diabetes.Approximately 25.8 million people – about 8.3% of the
population – have diabetes in the United States, where the disease is
estimated to be the seventh leading cause of death. The World Health
Organization projects diabetes will be the seventh leading cause of death
worldwide by 2030.

The central defect of diabetes is high levels of blood glucose. Blood glucose
levels are the result of orchestrated actions by a number of hormones,
including insulin, incretins, glucagon, and others; and organs including the
pancreas, liver, kidneys, and muscle and fat tissue. The role of the kidneys
in blood glucose regulation is often overlooked but is unique because, unlike
any other organ, the kidneys can synthesize glucose, utilize it for fuel,
return it to the bloodstream, and excrete it.

Type 2 diabetes comprises 90 percent of people with diabetes, which is chronic
and affects the body's ability to metabolize sugar (glucose), and is
characterized by the inability of pancreatic beta cell function to keep up
with the body's demand for insulin.

The World Health Organization estimates that 44 percent of the global diabetes
burden is attributable to overweight and obesity. Worldwide, an estimated one
billion adults are considered overweight and another 475 million are obese. 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.

Nearly half of adults with type 2 diabetes do not achieve recommended levels
of glucose control.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. ^

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.


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

You may be at higher risk of dehydration if you:

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

  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.

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:

       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

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
  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.


  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.

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

Signs and symptoms of low blood sugar may include:

  ofast heart-beat
  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

Please see the full Prescribing Information and Medication Guide.

About Janssen Research & Development, LLC
At Janssen, we are dedicated to addressing and solving some of the most
important unmet medical needs of our time in oncology, immunology,
neuroscience, infectious diseases and vaccines, 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. Janssen Research & Development, LLC and Janssen
Pharmaceuticals, Inc. are part of the Janssen Pharmaceutical Companies of
Johnson & Johnson. Please visit http://www.janssenrnd.comfor more

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 December 30, 2012. Copies of this Form 10-K, as well as subsequent
filings, are available online at, 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.

SOURCE Janssen Research & Development, LLC

Contact: Christina Holden, 908-927-3581 office, 201-650-2355 cell,; Christina Chan, 908-927-5769 office, 908-635-2406 cell,; Investor contacts: Stan Panasewicz, 732-524-2524 office;
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