New Real-World Data Show Adults with Type 2 Diabetes, Including Those Taking Multiple Diabetes Medications, Achieve Blood Glucose Treatment Goals After Using INVOKANA® (canagliflozin)

RARITAN, N.J., May 18, 2015 /PRNewswire/ -- Janssen Pharmaceuticals, Inc. (Janssen) today announced results from three real-world analyses, which found significant improvements in blood glucose (A1C) in adults with type 2 diabetes after using the once-daily oral medication INVOKANA^® (canagliflozin).  In addition, when prescribed for patients already taking multiple blood-glucose-lowering medications, the data found INVOKANA^® is associated with further improved A1C control, even when some patients stopped using other blood-glucose-lowering medications.

The results presented today are among a total of 15 presentations related to INVOKANA^® made at the 20th Annual Meeting of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) in Philadelphia, held May 16 to 20.

"These data show INVOKANA^® provides significant reductions in A1C in people with type 2 diabetes seen in everyday clinical practice, including patients with more advanced disease than many of our clinical trial participants," said Robert Bailey, M.D., Director, Health Economics and Outcomes Research, Janssen Scientific Affairs. "The findings from these analyses, representing diverse patient types, are generally consistent with those from our Phase 3 clinical development program, and may illustrate how INVOKANA^® is performing in real-world settings."

A1C, or hemoglobin A1C, is a measure of average blood glucose over the past two to three months. The American Diabetes Association recommends most adults with type 2 diabetes maintain A1C levels of 7 percent or less. Medicare and many health plans use an A1C level of less than 8 percent as a treatment goal.¹ Studies have shown that every percentage point drop in A1C levels can reduce the risk of diabetes complications by 40 percent.² However, nearly half of all adults with type 2 diabetes do not achieve recommended levels of blood glucose control.

INVOKANA^® is used along with diet and exercise to lower blood glucose in adults with type 2 diabetes. It is the first in a new class of medications called sodium glucose cotransporter 2 (SGLT2) inhibitors available in the United States.

The Presentations

Glycated Hemoglobin Control in Patients With Type 2 Diabetes Mellitus Treated With Canagliflozin In A Real-World Setting (Abstract 39834, Poster PDB27): Patrick Lefebvre, MA, from Groupe d'analyse, Ltee in Montreal, Canada, presented a retrospective observational study based on 16,163 adults with type 2 diabetes who had been taking INVOKANA^® (100 mg or 300 mg daily). Prior to starting on INVOKANA^®, the patients had been taking an average of 2.7 anti-hyperglycemic agents (AHAs) to control their blood glucose.

INVOKANA^® was associated with statistically significant increases in the percent of patients who reached A1C goals. Among patients with a baseline A1C of 7 percent or more, 21.2 percent attained an A1C of less than 7 percent at the earliest assessment (three months). In total, 59.5 percent achieved an A1C of less than 8 percent at three months. The proportion of patients achieving these A1C goals remained stable at six, nine and 12 months. The mean baseline A1C among patients with a baseline A1C above 7 percent was approximately 8.8 percent; mean A1C decreased to 8.0 percent after three months and also remained stable (P < 0.0001 vs. baseline at each time point).

Additionally, among patients with systolic / diastolic blood pressure (SBP / DBP) of at least 140/90 mmHg at baseline, 60.0 percent and 75.6 percent achieved blood pressure reduction goals of SBP less than 140 mmHg and DBP less than 90 mmHg, respectively, after three months. The proportions of patients attaining BP control were similar after six, nine and 12 months.

The analysis utilized the Cegedim Strategic Data US electronic medical records database, in which 60 percent of contributors are primary care providers.

Real-World Treatment Patterns of Antihyperglycemic Agents among Patients with Type 2 Diabetes Mellitus Initiated On Canagliflozin (Abstract 39833, Poster PDB16): Wing Chow, PharmD, MPH, from Janssen Scientific Affairs, presented a retrospective cohort study assessing 4,017 people with type 2 diabetes who had been taking INVOKANA^® (100 mg or 300 mg daily).

The study found the proportion of patients with A1C less than 8 percent increased from 39 percent at baseline to 66 percent at follow up. Similarly, the proportion with A1C less than 7 percent increased from 13 percent to 28 percent. INVOKANA^® was associated with an average A1C reduction from 8.6 percent at baseline to 7.8 percent at follow up. Additionally, of the 80 percent of patients who were using INVOKANA^® in combination with other AHAs, 20 percent discontinued at least one AHA during the follow-up period.

A total of 826 patients had A1C assessments at baseline, before starting INVOKANA^®, and after an average of 112 days after use of INVOKANA^®. The study was based on the Optum Research Database, a large U.S. health plan for commercial and Medicare Advantage enrollees.

Real-World Canagliflozin Utilization: Impact on Glycemic Control in Patients with Type 2 Diabetes Mellitus (Abstract 39881, Poster PDB13): Lisa Meckley, PhD, Trinity Partners, Waltham, Massachusetts, presented a retrospective cohort study based on 268 adults with type 2 diabetes included in the 2013 Inovalon MORE² Registry, which consists of commercial, managed Medicare and Medicaid medical claims, pharmacy claims and laboratory data. After an average of 120 days of taking INVOKANA^®, the proportion of patients with A1C less than 8 percent increased from 26 percent at baseline to 38 percent. The proportion with A1C less than 7 percent increased from 15 percent to 31 percent. INVOKANA^® provided a statistically significant reduction in A1C levels from 8.3 percent to 7.6 percent (P < 0.001).

For more details about these studies, visit the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Annual Meeting online, search for abstracts on "diabetes" and with "canagliflozin" in the title, and see presentations PDB13, PDB16 and PDB27.

About Type 2 Diabetes
Of the approximately 29 million people who have diabetes in the United States, 90 to 95 percent of them have type 2 diabetes, which is chronic, 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.

Nearly half of adults with type 2 diabetes do not achieve recommended levels of glucose control, and, if left uncontrolled, type 2 diabetes can lead to serious complications.^3,4,5 Improved glycemic control has been demonstrated to reduce the onset and progression of these complications.⁵

WHAT IS INVOKANA^®?
INVOKANA^® is a prescription medicine used along with diet and exercise to lower blood sugar in adults with type 2 diabetes. INVOKANA^® is not for people with type 1 diabetes or with diabetic ketoacidosis (increased ketones in blood or urine). It is not known if INVOKANA^® is safe and effective in children under 18 years of age.

IMPORTANT SAFETY INFORMATION

INVOKANA^® can cause important side effects, including:

• Dehydration (the loss of body water and salt), which 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 have low blood pressure, take medicines to lower your blood pressure (including diuretics [water pills]), are on a low sodium (salt) diet, have kidney problems, or are 65 years of age or older
• Vaginal yeast infection. Women who take INVOKANA^® may get vaginal yeast infections. Symptoms include: vaginal odor, white or yellowish vaginal discharge (discharge may be lumpy or look like cottage cheese), or vaginal itching
• Yeast infection of the penis (balanitis or balanoposthitis). Men who take INVOKANA^® may get a yeast infection of the skin around the penis. Symptoms include: redness, itching, or swelling of the penis; rash of the penis; foul-smelling discharge from the penis; or pain 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.

Do not take INVOKANA^® if you:

• are allergic to canagliflozin or any of the ingredients in INVOKANA^®. Symptoms of allergic reaction may include: rash; raised red patches on your skin (hives); or swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing
• have severe kidney problems or are on dialysis

Before you take INVOKANA^®, tell your doctor if you have kidney problems, liver problems, are on a low sodium (salt) diet, ever had an allergic reaction to INVOKANA^®, or have other medical conditions.

Tell your doctor if you are or plan to become pregnant, are breastfeeding, or plan to breastfeed. It is not known if INVOKANA^® will harm your unborn baby. It is also not known if INVOKANA^® passes into your breast milk.

Tell your doctor about all the medicines you take, including prescription and non­prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take diuretics (water pills), rifampin (used to treat or prevent tuberculosis), phenytoin or phenobarbital (used to control seizures), ritonavir (Norvir^®, Kaletra^®, Lopinavir^® - used to treat HIV infection), or digoxin (Lanoxin^® - used to treat heart problems).

Possible Side Effects of INVOKANA^®
INVOKANA^® may cause serious side effects, including: kidney problems, a high amount of potassium in your blood (hyperkalemia), or low 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: headache, drowsiness, weakness, dizziness, confusion, irritability, hunger, fast heartbeat, sweating, shaking, or feeling jittery.

Serious 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.

The most common side effects of INVOKANA^® include: vaginal yeast infections and yeast infections of the penis; urinary tract infection; or changes 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. 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 the full Product Information and Medication Guide.

Canagliflozin is licensed from Mitsubishi Tanabe Pharma Corporation.

Trademarks are those of their respective owners.

About Janssen Pharmaceuticals, Inc.

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 Pharmaceuticals, Inc. is one of the Janssen Pharmaceutical Companies of Johnson & Johnson. Please visit JanssenPharmaceuticalsInc.com for more information.

This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding product development. 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 known 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: challenges and uncertainties inherent in new product development, including the uncertainty of clinical success and of obtaining regulatory approvals; competition, including technological advances, new products and patents attained by competitors; challenges to patents; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. 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 28, 2014, including in Exhibit 99 thereto, and the company's 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. None of the Janssen Pharmaceutical Companies or Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

¹ National Committee for Quality Assurance. http://www.ncqa.org/HEDISQualityMeasurement/HEDISMeasures.aspx. Accessed 2015 May 7.
² 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 Disease Control and Prevention, 2011.
³ Bailey CJ. Renal glucose reabsorption inhibitors to treat diabetes. Trends Pharmacol Sci. 2011;32(2):63-71.
⁴ Casagrande 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.
⁵ World Health Organization, Media Centre, Diabetes, Fact sheet Number 312. Available at: http://www.who.int/mediacentre/factsheets/fs312/en/.

SOURCE Janssen Pharmaceuticals, Inc.

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