July 23, 2014 6:50 AM ET

Healthcare Providers and Services

Company Overview of Janssen Inc.

Company Overview

Janssen Inc. distributes healthcare products. It offers products for mental wellness, anemia and fatigue, kidney disease, women’s health, wound healing, Alzheimer disease, eldercare, psychiatry, neurology, dementia, attention deficit hyperactivity disorder, immunology, pain management, gastroenterology, infectious diseases, and urology. Janssen Inc. was formerly known as Janssen-Ortho Inc. The company was founded in 1941 and is based in Toronto, Canada with a division office in Montreal. Janssen Inc. operates as a subsidiary of Johnson & Johnson.

19 Green Belt Drive

Toronto, ON M3C 1L9

Canada

Founded in 1941

Phone:

416-449-9444

Fax:

416-449-2658

Key Executives for Janssen Inc.

Janssen Inc. does not have any Key Executives recorded.

Janssen Inc. Key Developments

Health Canada Approves Janssen Inc.'s INVOKANA (canagliflozin)

Janssen Inc. announced that Health Canada has approved INVOKANA (canagliflozin), an oral, once-daily prescription treatment used to lower blood glucose (sugar) levels in adults with type 2 diabetes. INVOKANA belongs to a new class of medications called sodium glucose co-transporter 2 (SGLT2) inhibitors that offers a novel approach to treating diabetes by increasing the loss of glucose in the urine. Of the three million Canadians living with diabetes, 90% have been diagnosed with type 2 diabetes.Despite the numerous treatment options available, approximately 50% of patients don't reach the level of glucose control recommended by their doctor. As glucose is filtered from the blood in the kidneys it is reabsorbed into the bloodstream. SGLT2 is an important transporter responsible for this reabsorption. INVOKANA selectively inhibits SGLT2 and as a result, promotes the loss of glucose in the urine, lowering blood sugar levels in adults with type 2 diabetes. The Health Canada approval of INVOKANA is based on a comprehensive global Phase 3 clinical program, including 713 Canadians in six studies, which was one of the largest global clinical programs in type 2 diabetes ever conducted. 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 this program showed that the 100 mg and the 300 mg doses of INVOKANA significantly improved glycemic control, body weight and systolic blood pressure. In two studies comparing INVOKANA as an add-on therapy with metformin to current standard treatments, INVOKANA dosed at 300 mg provided superior reductions compared to sitagliptin and to glimepiride in both A1C levels (measure that reflects the average blood sugar levels over the past three months) and body weight. Results from the Phase 3 clinical program 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. Due to its mechanism of action INVOKANA may cause volume depletion (dehydration). Uncommon adverse events related to reduced intravascular volume including orthostatic hypotension, postural dizziness (both defined as fainting, feeling dizzy or lightheaded due to a drop in blood pressure when stand up) and hypotension (low blood pressure). This happens more often in older people (aged 75 and over), people with kidney problems and people taking water tablets (diuretics).

Janssen Announces Formation of Janssen Global Public Health

Janssen has announced the formation of Janssen Global Public Health, or Janssen GPH. Janssen GPH will partner with other organizations within the company as appropriate to advance global public health goals. Adrian Thomas, M.D., vice president of Global Market Access, Global Commercial Strategy Operations, and Global Public Health, and Wim Parys, M.D., vice president, R&D Global Public Health, will jointly lead Janssen GPH. Janssen GPH will be responsible for clinical and product development and creating and implementing innovative new access strategies for a growing portfolio of pharmaceuticals, diagnostics, and services for diseases significantly impacting resource-limited countries and emerging markets, and includes: SIRTURO, Long-acting rilpivirine, Dapivirine microbicidal ring, Reformulated flubendazole, Reformulated mebendazole, and UNITE Project. Janssen GPH is overseeing the development and implementation of a global access framework for SIRTURO (R), approved by the FDA as part of combination therapy in adults with pulmonary multi-drug resistant tuberculosis (MDR-TB) in December 2012 and by Russian regulatory authorities in October 2013. Janssen GPH will continue to invest in clinical research toward the development of a long-acting, injectable version of the HIV medicine rilpivirine, a delivery method allowing less frequent dosing.

Janssen Inc. Announces Health Canada Approval of STELARA(R) for Treatment of Active Psoriatic Arthritis

Janssen Inc. announced that Health Canada approved STELARA(R) (ustekinumab) for the treatment of adult patients with active psoriatic arthritis, alone or in combination with methotrexate. Health Canada's approval is supported by findings from two pivotal Phase 3 Multicenter, Randomised, Double-blind, Placebo-controlled trials of Ustekinumab, a Fully Human anti-IL-12/23p40 Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Psoriatic Arthritis (PSUMMIT I and PSUMMIT II), which evaluated the efficacy and safety of subcutaneously-administered STELARA(R) 45 mg or 90 mg at weeks 0, 4 and then every 12 weeks. Alternatively, 90 mg may be used for patients with a body weight greater than 100 kg. The trials included 927 patients diagnosed with active psoriatic arthritis who had at least five tender and five swollen joints in spite of previous treatment with conventional therapy.PSUMMIT II also included 180 patients with previous exposure to one or more tumor necrosis factor (TNF) inhibitors. Results from PSUMMIT I showed that at week 24, 42% and 50% of patients receiving STELARA(R) 45 mg and 90 mg, respectively, achieved at least 20% improvement in signs and symptoms according to the American College of Rheumatology criteria (ACR 20), the primary endpoint for both studies. In PSUMMIT II, 44% of patients receiving STELARA(R) 45 mg and 44% of patients receiving STELARA(R) 90 mg achieved ACR 20 at week 24. Additionally, STELARA(R) improved soft tissue components of the disease, including dactylitis (inflammation of the finger or toe), enthesitis (inflammation of the entheses, the sites where tendons or ligaments attach to bone) and skin component as measured by Psoriasis Area and Severity Index score (PASI) 75. Patients treated with STELARA(R) 45 mg and 90 mg also showed significant improvement in physical function as assessed using the Disability Index of the Health Assessment Questionnaire (HAQ-DI) at week 24 as compared to placebo in both PSUMMIT I and PSUMMIT II--a secondary endpoint in the studies. The safety results of STELARA(R) observed in the PSUMMIT studies were consistent with the overall safety profile of STELARA(R) in the labelled chronic moderate to severe plaque psoriasis indication, which has five years of safety experience from clinical trials. Common side effects of STELARA(R) include upper respiratory infections, headache, tiredness, joint pain and nausea. These are not all of the possible side effects with STELARA(R).

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