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

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.

RARITAN, N.J., JUNE 18, 2013 – 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) 73rd 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

• “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)
• “Efficacy and Safety of Canagliflozin in Older Subjects with Type 2 Diabetes Mellitus” (abstract 76-LB)
• “Canagliflozin is Effective and Generally Well Tolerated in Subjects with Type 2 Diabetes Mellitus and Stage 3 Chronic Kidney Disease” (abstract 73-LB)

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

• “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 23rd during the 12:00-2:00 PM session

• “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)
• “Efficacy and Safety of Canagliflozin Monotherapy in Subjects with Type 2 Diabetes Mellitus Over 52 Weeks” (results from DIA3005; abstract 1164-P)
• “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)
• “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)
• “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)
• “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)
• “Genital Mycotic Infections with Canagliflozin in Subjects with Type 2 Diabetes Mellitus” (abstract 1069-P)
• “Urinary Tract Infection with Canagliflozin in Subjects with Type 2 Diabetes Mellitus” (abstract 1139-P)
• “Canagliflozin Lowers A1C and Blood Pressure Through Weight Loss-Independent and Weight Loss-Associated Mechanisms” (abstract 1110-P)
• “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 23rd during the 4:30-6:30 PM session

• “In Vitro Characterization of the Selective Sodium Glucose Co-Transporter 2 Inhibitor Canagliflozin” (abstract 239-OR)

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

• “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 23rd during the 12:00-2:00 PM session

• “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 23rd during the 12:00-2:00 PM session

• “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)
• “Patient Reported Perspectives on Diabetes Disease, Comorbidities, Glucose Control, and Adherence” (results from a National Health Wellness Survey; abstract 1283-P)
• “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)
• “Vulvovaginal Candidiasis and Urinary Tract Infection in Women With and Without Type 2 Diabetes Mellitus” (abstract 1254-P)
• “What fraction of type 2 diabetics in the United States meet the recommended levels of HDL cholesterol, one half or two thirds?” (abstract 1565-P)

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

• “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: http://jnssn.us/15HsH6x.

About INVOKANA™
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 [1,2], 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.[3] 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.[4] The World Health Organization projects diabetes will be the seventh leading cause of death worldwide by 2030.[5]

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.[6] 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.[7]

Type 2 diabetes comprises 90 percent of people with diabetes,[8] 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.[9] Worldwide, an estimated one billion adults are considered overweight and another 475 million are obese.[10] 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.[11,12] If left uncontrolled, type 2 diabetes can lead to serious complications.[13] Improved glycemic control has been demonstrated to reduce the onset and progression of these complications.[14]

INDICATION STATEMENT
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.
• 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 under 18 years of age.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about INVOKANA™?
INVOKANA™ can cause important side effects, including:

• Dehydration. 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:

• have low blood pressure
• take medicines to lower your blood pressure, 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 take INVOKANA™ may get vaginal yeast infections. Symptoms of a vaginal yeast infection include:
• vaginal odor
• 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 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:
  • redness, itching, or swelling of the penis
  • rash of the penis
  • foul smelling discharge from the penis
  • 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. 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:

• are 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:
  • rash
  • raised red patches on your skin (hives)
  • swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing
• have 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:

• have kidney problems
• have liver problems
• are on a low sodium (salt) diet. Your doctor may change your diet or your dose of INVOKANA™.
• have ever had an allergic reaction to INVOKANA™
• have other medical conditions
• are 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.
• are 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:

• 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)
• digoxin (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™?

• Take INVOKANA™ by mouth 1 time each day exactly as your doctor tells you to take it.
• Your doctor will tell you how much INVOKANA™ to take and when to take it. Your doctor may change your dose if needed.
• It is best to take INVOKANA™ before the first meal of the day.
• Your 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™?”
• If 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.
• If 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.
• Stay on your prescribed diet and exercise program while taking INVOKANA™.
• Check your blood sugar as your doctor tells you to.
• INVOKANA™ will cause your urine to test positive for glucose.
• Your 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.
• Your 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™?”

• kidney problems
• a high amount of potassium in your blood (hyperkalemia)
• 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™.