June 23, 2017 1:11 AM ET

Pharmaceuticals

Company Overview of Janssen Inc.

Company Overview

Janssen Inc. is a pharmaceutical company. The company develops products in therapeutic, cardiovascular and metabolism, immunology, infectious diseases and vaccines, neuroscience, oncology, and other areas. Its products are used by doctors, nurses and patients, and mothers and fathers. Janssen Inc. was formerly known as Janssen-Ortho Inc. The company was founded in 1941 and is based in Toronto, Canada. 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

Janssen Inc. Receives Health Canada Approval of DARZALEX® (daratumumab)

Janssen Inc. announced that Health Canada has approved DARZALEX® (daratumumab), in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy. Due to the high unmet medical need for multiple myeloma patients, DARZALEX® was granted a Priority Review by Health Canada for this submission. Multiple myeloma is an incurable blood cancer that occurs when malignant plasma cells grow uncontrollably in the bone marrow. The disease can be very complex to treat as most patients relapse or become resistant to standard therapies, making the approval of new treatment options so important. Janssen looks forward to working with insurers to determine how DARZALEX® can be made available for patients through both private and public insurance plans. In June 2016, Health Canada issued a Notice of Compliance with Conditions (NOC/c) approving DARZALEX® for those with multiple myeloma who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD), or who are refractory to both a PI and an IMiD (meaning they didn't respond to treatment). With this new approval, patients can now use DARZALEX® treatment earlier in their disease. Data from two Phase 3 studies supported this new approval. They include the open-label, randomized clinical studies POLLUX (MMY3003) and CASTOR (MMY3004).

Janssen Inc. Announces Health Canada Approval of INVOKAMET™ for the Treatment of Adults with Type 2 Diabetes

Janssen Inc. announced that INVOKAMET™, a twice daily fixed-dose therapy combining INVOKANA® (canagliflozin) and metformin hydrochloride into a single tablet, for the treatment of adults with type 2 diabetes is now available in Canada. INVOKANA® is the first sodium glucose co-transporter 2 (SGLT2) inhibitor approved in Canada that works with the kidney to promote the loss of glucose in the urine. Metformin, which is commonly prescribed early in the treatment of type 2 diabetes, decreases the production of glucose in the liver and improves the body's response to insulin. INVOKAMET™ is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. It should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis (DKA). INVOKAMET™ was approved by Health Canada on June 1, 2016. Study results demonstrated administration of INVOKAMET™ was equivalent to co-administration of corresponding doses of INVOKANA® and metformin as individual tablets. The co-administration of INVOKANA® and metformin has been studied in six Phase 3 clinical studies that enrolled 5,031 patients with type 2 diabetes. The Phase 3 studies evaluated INVOKANA® in combination with metformin, compared to metformin alone or to metformin plus another diabetes therapy. The studies were part of the comprehensive global Phase 3 program for INVOKANA® that enrolled 10,285 patients, one of the largest clinical programs in type 2 diabetes submitted to health authorities to date. The Phase 3 studies showed the combination of INVOKANA® and metformin lowered blood sugar and in pre-specified secondary endpoints, was associated with significant reductions in body weight and systolic blood pressure. two studies comparing INVOKANA® plus metformin to current standard treatments plus metformin — one studying sitagliptin and the other studying glimepiride — INVOKANA® dosed at 300 mg provided greater reductions in A1C levels and body weight than either comparator. A1C is the per cent of red blood cell hemoglobin with glucose attached to it and an indicator of average blood glucose concentration over the previous two to three months. In the two studies, the overall incidence of adverse events was similar with INVOKANA® and the comparators. Common side effects reported for INVOKANA® include vaginal yeast infection, rash or redness of the penis or foreskin, urinary tract infection, increased urination, constipation, nausea and feeling thirsty. Common side effects reported for metformin are diarrhea, excess gas, abdominal discomfort, nausea/vomiting and indigestion. Lactic acidosis is a rare, but serious, metabolic complication that can occur due to metformin accumulation during treatment with INVOKAMET™. This is more common in people whose kidneys are not working properly. As well, clinical trial cases of diabetic ketoacidosis, a serious life-threatening condition requiring urgent hospitalization, have been reported in patients with type 1 and type 2 diabetes mellitus treated with SGLT2 inhibitors, including INVOKANA®. Hypoglycemia does not occur in patients receiving metformin alone under usual circumstances of use. NVOKANA® can increase the risk of hypoglycemia when combined with insulin or a medication that increases insulin levels (example: a sulfonylurea). Therefore, a lower dose of insulin or insulin-raising medication may be required to minimize the risk of hypoglycemia when used in combination with INVOKAMET™.

Health Canada Issues Notice of Compliance for Janssen's SIMPONI® for Treatment Indicated for Non-Radiographic Axial Spondyloarthritis

Janssen Inc. announced Health Canada has approved SIMPONI® (golimumab) for the treatment of adults with severe active non-radiographic axial spondyloarthritis (nr-AxSpA) with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence who have had an inadequate response to or are intolerant to nonsteroidal anti-inflammatory drugs (NSAIDs). This is the fifth indication for SIMPONI® in Canada, which was approved originally by Health Canada in 2009 for adults living with moderately to severely active rheumatoid arthritis (RA).

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