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New Long-Term Data Show INVOKANA® (canagliflozin) Lowers Blood Glucose in Older Patients with Type 2 Diabetes Inadequately Controlled on Other Therapies

New Long-Term Data Show INVOKANA® (canagliflozin) Lowers Blood Glucose in Older Patients with Type two Diabetes Inadequately Controlled on Other Therapies

Phase three Study Results Also Demonstrate INVOKANA® Reduces Secondary Endpoints of Trunk Weight and Systolic Claret Pressure

Note: This release corresponds to American Diabetes Association (ADA) abstract 268-OR

RARITAN, North.J., JUNE 16, 2014 – Janssen Enquiry & Development, LLC (Janssen) today appear new results from a 104-calendar week Phase 3 clinical report evaluating the long-term effects of INVOKANA^® (canagliflozin) in patients aged 55 to 80 years with type ii diabetes inadequately controlled on current antihyperglycemic therapies. The randomized double-bullheaded study showed INVOKANA^® 100 milligrams (mg) and 300 mg, compared to placebo, provided greater reductions in blood glucose (A1C), and greater reductions in secondary endpoints of fasting plasma glucose, body weight and systolic claret pressure.

Older adults have the highest prevalence of diabetes of whatsoever age group, with more than than 25 per centum of U.S. adults aged 65 years and older living with diabetes.[1] The aging of the overall U.S. population is acknowledged as a driver of the diabetes epidemic.[2] Type 2 diabetes comprises xc to 95 percent of people with diabetes and if left uncontrolled can pb to serious complications.[1]

"The results presented today reinforce the positive furnishings of INVOKANA^® on primal health measures for older people with type 2 diabetes," said Norman Rosenthal, MD, FACE, FACP, canagliflozin compound evolution team leader, Janssen. "As INVOKANA^® continues its rapid uptake in the type 2 diabetes customs, we remain committed to enhancing understanding of its full impact on different patient types and the healthcare organization overall."

In the long-term study (DIA3010), after 104 weeks, levels of A1C, the primary endpoint, were significantly reduced with INVOKANA^® 100 mg and 300 mg, respectively, relative to placebo: -0.49 percentage (95 percent conviction interval [CI] -0.65, -0.32) and -0.lx percent (CI -0.77, -0.44). A1C, likewise called hemoglobin A1c, is the per centum of blood-red blood jail cell hemoglobin with glucose fastened to it, and is an indicator of average blood glucose over the previous ii to three months.[3]

INVOKANA^® 100 mg and 300 mg, respectively, also resulted in pregnant improvements in a number of secondary endpoints relative to placebo:

• The percent of patients reaching the A1C goal level of less than 7.0 percent: xv.6 per centum (CI vii.2, 24.0) and 21.seven pct (CI thirteen.0, 30.3)
• Body weight reduction: -two.three percent (CI -3.ane, -one.6) and -iii.2 percent (CI -4.0, -2.4)
• Fasting plasma glucose reduction: -21.4 mg/dL (CI -28.5, -14.2) and -23.4 mg/dL (CI -xxx.6, -16.two)
• Systolic blood pressure level reduction: -5.8 mm Hg (CI -8.0, -3.5 and -7.five mm Hg (CI -9.eight, -v.two)
• Increased levels of HDL-C (high-density lipoprotein cholesterol): 3.6 percent (CI 0.4, half dozen.ix) and 4.viii per centum (CI 1.v, 8.1)

Handling with INVOKANA^® was also associated with non-pregnant changes, relative to placebo, in blood triglycerides and LDL-C (low-density lipoprotein cholesterol).

The overall incidence of adverse events (AEs) for INVOKANA^® 100 mg, 300 mg and placebo, respectively, was 88 percent, 90 percent, and 86 percent. AE-related discontinuation rates were five per centum, 10 percent and 7 percent, and serious AE rates were similar beyond groups. Higher incidences of urinary tract infections, genital mycotic infections, osmotic diuresis (increased urination)-related AEs, and book depletion were seen with INVOKANA^® compared to placebo. Hypoglycemia was more common with INVOKANA^® than placebo, with few astringent episodes across groups. The AE contour was consistent with that seen amid a broad range of INVOKANA^®-treated patients.

For more than details about the study, visit the American Diabetes Clan Scientific Sessions website and search online abstracts for presentation number 268-OR.

The results presented today are among a total of xv presentations on INVOKANA^® made at the American Diabetes Clan 74^th Scientific Sessions^® in San Francisco.

Well-nigh INVOKANA^®

INVOKANA^® is the first sodium glucose co‐transporter 2 (SGLT2) inhibitor available in the United States.

Information technology is an oral medication that reduces the reabsorption of glucose past the kidney, thereby promoting the loss of glucose in the urine and lowering blood glucose levels in adults with type 2 diabetes. In clinical trials, INVOKANA^® as well has been shown to provide secondary endpoint reductions in trunk weight and systolic blood pressure.

In March 2013, the United States Food and Drug Administration (FDA) approved INVOKANA^® as a single agent as an adjunct to nutrition and exercise to lower blood sugar in adults with type 2 diabetes. INVOKANA^® has since been widely adopted and today it is the number-1 branded therapy prescribed by U.Due south. endocrinologists when adding or switching non‐insulin type ii diabetes medications. INVOKANA^® also is canonical in the European Union (31 countries), Commonwealth of australia, Canada, Chile, Mexico, Switzerland, Singapore, Republic of korea, Peru, Aruba, Kuwait, United Arab Emirates and Republic of guatemala.

INVOKANA^® has been studied as monotherapy and in combination with other blazon two diabetes therapies.

The comprehensive global Stage 3 clinical development programme for INVOKANA^® enrolled x,285 patients in 9 studies and was 1 of the largest clinical programs in type ii diabetes submitted to health authorities to date. In two divide trials, INVOKANA^® 300mg demonstrated greater reductions in A1C versus sitagliptin 100mg at 52 weeks, as well as greater reductions in body weight and systolic blood pressure. The recommended starting dose on INVOKANA^® is 100mg. A1C is the percentage of red claret cell hemoglobin with glucose attached to it and an indicator of average blood glucose over the previous two to three months.

The nigh 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.

About Type 2 Diabetes

An estimated 371 million worldwide are living with diabetes[four] and approximately 25.8 1000000 people have diabetes in the United States.[five] Type ii diabetes comprises 90 percent of people with diabetes,[6] which is chronic and affects the trunk's ability to metabolize sugar (glucose), and is characterized past the inability of pancreatic beta cell function to keep up with the trunk's demand for insulin.

Nearly half of adults with type 2 diabetes practise not achieve recommended levels of glucose command, and if left uncontrolled, type 2 diabetes tin lead to serious complications.[7],[8],[9] Improved glycemic command has been demonstrated to reduce the onset and progression of these complications. [10]

INDICATION STATEMENT
WHAT IS INVOKANA ^® ?

• INVOKANA^® is a prescription medicine used along with diet and exercise to lower claret carbohydrate in adults with type two diabetes.
• INVOKANA^® is not for people with blazon 1 diabetes.
• INVOKANA^® is not for people with diabetic ketoacidosis (increased ketones in blood or urine).
• It is not known if INVOKANA^® is safe and effective in children nether 18 years of age.

IMPORTANT SAFETY INFORMATION

WHAT IS THE MOST Important Information I SHOULD KNOW ABOUT INVOKANA ^® ?
INVOKANA^® can crusade important side furnishings, including:

• Dehydration. INVOKANA ^®  can crusade some people to have dehydration (the loss of body water and salt). Dehydration may cause yous to feel dizzy, faint, lightheaded, or weak, specially when you lot stand upwardly (orthostatic hypotension).

  You may exist at higher run a risk of dehydration if you:

  • have low blood pressure
  • take medicines to lower your blood pressure level, including diuretics (water pill)
  • are on low sodium (salt) diet
  • have kidney problems
  • are 65 years of age or older

• Vaginal yeast infection.Women who have INVOKANA^® may become vaginal yeast infections. Symptoms of a vaginal yeast infection include:
  • vaginal scent
  • white or yellowish vaginal discharge (discharge may be lumpy or look like cottage cheese)
  • vaginal itching
    
• Yeast infection of the penis (balanitis or balanoposthitis).Men who take INVOKANA^® may get a yeast infection of the skin effectually the penis. Certain men who are not circumcised may take swelling of the penis that makes information technology difficult to pull back the skin around the tip of the penis. Other symptoms of yeast infection of the penis include:
  • redness, itching, or swelling of the penis
  • rash of the penis
  • foul smelling discharge from the penis
  • hurting in the skin around penis

Talk to your doctor about what to practice if you go symptoms of a yeast infection of the vagina or penis. Your doctor may suggest y'all employ an over-the-counter antifungal medicine. Talk to your doctor correct away if you use an over-the-counter antifungal medication and your symptoms do not become away.
WHO SHOULD Non TAKE INVOKANA ^® ?
Do not take INVOKANA ^®  if y'all:

• are allergic to canagliflozin or any of the ingredients in INVOKANA^®. See the stop of the Medication Guide for a list of ingredients in INVOKANA^®. Symptoms of allergic reaction to INVOKANA^® may include:
  • rash
  • raised red patches on your skin (hives)
  • swelling of the face, lips, natural language, and throat that may cause difficulty in breathing or swallowing
• have severe kidney issues or are on dialysis

WHAT SHOULD I TELL MY Md BEFORE TAKING INVOKANA ^® ?
Before you accept INVOKANA^®, tell your doc if y'all:

• have kidney problems
• accept liver problems
• are on a depression sodium (salt) diet. Your doctor may change your diet or your dose of INVOKANA^®.
• have e'er had an allergic reaction to INVOKANA^®
• have other medical conditions
• are pregnant or plan to get significant. It is not known if INVOKANA^® will damage your unborn baby. If y'all are pregnant, talk with your doctor well-nigh the all-time way to control your claret sugar while you lot are significant.
• are breastfeeding or program to breastfeed. It is not known if INVOKANA^® passes into your breast milk. Talk with your doctor about the best fashion to feed your babe if you are taking INVOKANA^®.

Tell your medico about all the medicines you accept, 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 medico if you take:

• diuretics (water pills)
• rifampin (used to care for or foreclose tuberculosis)
• phenytoin or phenobarbital (used to command seizures)
• ritonavir (Norvir®, Kaletra®, Lopinavir ®)* (used to treat HIV infection)
• digoxin (Lanoxin®)* (used to care for heart issues)

Inquire your doctor or chemist for a listing of these medicines if you are not sure if your medicine is listed higher up.
Know the medicines you accept. Continue a list of them and bear witness it to your doctor and pharmacist when yous become a new medicine.

HOW SHOULD I Take INVOKANA ^® ?

• Take INVOKANA^® past mouth 1 time each day exactly equally your physician tells y'all to take it.
• Your md will tell yous how much INVOKANA^® to take and when to take it. Your medico may change your dose if needed.
• Information technology is all-time to take INVOKANA^® before the first repast of the 24-hour interval.
• Your dr. may tell you to take INVOKANA^® along with other diabetes medicines. Depression blood sugar can happen more oftentimes when INVOKANA^® is taken with certain other diabetes medicines. See "What are the possible side effects of INVOKANA ^® ?"
• If you miss a dose, take it as shortly as you remember. If it is near time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled fourth dimension. Exercise non have two doses of INVOKANA^® at the same time. Talk to your doctor if y'all have questions nigh a missed dose.
• If you accept too much INVOKANA^®, telephone call your md or get to the nearest hospital emergency room right abroad. When your body is under some types of stress, such as fever, trauma (such as a automobile blow), infection, or surgery, the amount of diabetes medicine yous need may change. Tell your physician correct away if you have any of these conditions and follow your doctor's instructions.
• Stay on your prescribed diet and practise program while taking INVOKANA^®.
• Check your claret sugar as your doctor tells you to.
• INVOKANA^® will crusade your urine to test positive for glucose.
• Your doc may do certain blood tests earlier you start INVOKANA^® and during handling as needed. Your doctor may change your dose of INVOKANA^® based on the results of your blood tests.
• Your md 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 crusade serious side effects, including:
See"What is the most of import information I should know about INVOKANA ^® ?"

• kidney problems
• a high amount of potassium in your blood (hyperkalemia)
• low blood sugar (hypoglycemia). If y'all have INVOKANA^® with another medicine that can cause low claret saccharide, such every bit a sulfonylurea or insulin, your hazard of getting low blood saccharide 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:

• headache
• drowsiness
• weakness
• dizziness
• defoliation
• irritability
• hunger
• fast heartbeat
• sweating
• shaking or feeling jittery
• serious allergic reaction. If you take any symptoms of a serious allergic reaction, terminate taking INVOKANA^® and call your doctor correct away or go to the nearest hospital emergency room. Come across"Who should not have INVOKANA ^® ?". Your doc may give you lot a medicine for your allergic reaction and prescribe a different medicine for your diabetes.

The most common side effects of INVOKANA^® include:

• vaginal yeast infections and yeast infections of the penis (See"What is the most of import information I should know about INVOKANA ^® ?")
• urinary tract infection
• changes in urination, including urgent need to urinate more often, in larger amounts, or at night

Tell your doctor if you have any side outcome that bothers you lot or that does not go abroad. These are not all the possible side effects of INVOKANA^®. For more information, ask your dr. or pharmacist.

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

You may likewise study side furnishings to Janssen Scientific Affairs, LLC at 1-800-526-7736.

Please run across the full Prescribing Information and Medication Guide .

Trademarks are those of their respective owners.

About Janssen Research & Development, LLC
At Janssen, we are defended to addressing and solving some of the most important unmet medical needs of our fourth dimension 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 assist people throughout the world. Janssen Research & Development, LLC and Janssen Scientific Diplomacy, LLC are function of the Janssen Pharmaceutical Companies. Please visit http://world wide web.janssenrnd.com for more information.

This press release contains "frontwards-looking statements" equally defined in the Private Securities Litigation Reform Human action of 1995. The reader is cautioned not to rely on these forrard-looking statements. These statements are based on electric current expectations of futurity 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, whatever of the other Janssen Pharmaceutical Companies and/or Johnson & Johnson. Risks and uncertainties include, but are non limited to: economic factors, such equally interest rate and currency commutation charge per unit fluctuations; competition, including technological advances, new products and patents attained past competitors; challenges inherent in new product evolution, 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 intendance reforms; general manufacture weather condition including trends toward health care cost containment; and increased scrutiny of the health intendance manufacture by government agencies.  A farther list and description of these risks, uncertainties and other factors tin exist found in Johnson & Johnson's Annual Report on Form 10-M for the fiscal year concluded December 29, 2013, including in Exhibit 99 thereto, and our subsequent filings with the Securities and Exchange Commission. Copies of these filings are bachelor online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies nor Johnson & Johnson undertakes to update any forward-looking statements as a result of new information or hereafter events or developments.

###

References

[1] Centers 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 Affliction Command and Prevention, 2011.

[2] American Diabetes Association .Older Adults. Available at: world wide web.diabetes.org/in-my-community/awareness-programs/older-adults/.

[three] American Diabetes Clan. Living with diabetes: A1C. Bachelor at: http://world wide web.diabetes.org/living-with-diabetes/handling-and-intendance/blood-glucose-command/a1c/?keymatch=A1c.

[4] International Diabetes Federation, Diabetes Atlas fifth Edition 2012 Update, New estimates for 2012 of diabetes prevalence, mortality, and healthcare expenditures. Available at: http://www.idf.org/sites/default/files/IDF%20Diabetes%20Atlas%205th%20Edition%202012%20Update_1.ppt.

[5] Centers for Disease Command and Prevention. National diabetes fact sheet: national estimates and general information on diabetes and prediabetes in the U.s., 2011. Atlanta, GA: U.S. Department of Wellness and Human Services, Centers for Illness Control and Prevention, 2011.

[6] Definition, diagnosis and classification of diabetes mellitus and its complications. Part 1: Diagnosis and classification of diabetes mellitus. Geneva, Earth Health System, 1999 (WHO/NCD/NCS/99.2).

[7] Bailey CJ. Renal glucose reabsorption inhibitors to treat diabetes. Trends Pharmacol Sci. 2011;32(2):63-71.

[viii] Casagrande SS, Fradkin JE, Saydah SH, Rust KF, Cowie CC. The prevalence of meeting A1C, blood pressure level, and LDL goals among people with diabetes, 1988–2010. Diabetes Care. 2013 Feb xv. Epub ahead of print.

[9] Earth Wellness Organization, Media Centre, Diabetes, Fact sheet Number 312. Bachelor at: http://world wide web.who.int/mediacentre/factsheets/fs312/en/. Accessed April 1, 2013.

[10] Centers for Disease Command and Prevention. National diabetes fact sheet: national estimates and full 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.

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