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August 30, 2015 5:10 AM ET

Healthcare Providers and Services

Company Overview of Janssen Inc.

Company Overview

Janssen Inc. distributes healthcare products. The company 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. It also offers oral medications for the treatment of HIV infection in combination with other antiretroviral agents. 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

Janssen Inc. Announces Health Canada Issues Notice of Compliance with Conditions (NOC/c) for IMBRUVICA

Janssen Inc. announced that Health Canada has issued a Notice of Compliance with Conditions (NOC/c) for IMBRUVICA® (ibrutinib) an oral, once-daily single-agent therapy for the treatment of patients with relapsed or refractory mantle cell lymphoma (MCL). The approval with conditions is based on phase 2 clinical trial data that were published in the New England Journal of Medicine, showing an overall response rate (ORR) of nearly 68% based on investigator assessment. IMBRUVICA® is co-developed by Cilag GmbH International (a member of the Janssen Pharmaceutical Companies) and Pharmacyclics LLC, an AbbVie company. Janssen Inc. markets IMBRUVICA® in Canada. IMBRUVICA® was first approved in Canada in November 2014 for the treatment of patients with the blood cancer chronic lymphocytic leukemia (CLL), including those with 17p deletion, who have received at least one prior therapy, or for the frontline treatment of patients with CLL with 17p deletion. For this clinical use, IMBRUVICA® was issued marketing authorization without conditions. Health Canada has issued a marketing authorization with conditions under the NOC/c policy for IMBRUVICA® in the treatment of patients with relapsed or refractory MCL to reflect the promising nature of the clinical data. Under this policy, Janssen Inc. will provide Health Canada with data from additional studies to confirm the clinical benefit of IMBRUVICA®. Mantle cell lymphoma is a rare and aggressive form of blood cancer which arises from B cells, a type of white blood cell (lymphocyte) that originates in the bone marrow. In Canada, close to 500 new cases of MCL are diagnosed each year. MCL makes up about 6% of all non-Hodgkin lymphomas, affects more men than women, and usually occurs in adults over 50 years of age. The disease behaves aggressively and grows quickly, and is typically associated with a poor prognosis. The safety and efficacy of IMBRUVICA® in patients with MCL were evaluated in an open-label, multi-center, single-arm phase 2 study of 111 patients who had received at least one prior therapy. The primary endpoint of the study was ORR based on responses assessed according to the revised International Working Group (IWG) for non-Hodgkin's lymphoma (NHL) criteria. The most commonly occurring adverse reactions (20%) in the clinical trial were diarrhea (53%), fatigue (43%), nausea (32%), peripheral edema (30%), dyspnea (28%), constipation (28%), upper respiratory tract infection (26%), vomiting (23%), decreased appetite (23%), and thrombocytopenia (21%). Approximately 10% of patients receiving IMBRUVICA® in the clinical trial discontinued treatment due to adverse events. The most frequent adverse reaction to treatment discontinuation was subdural hematoma (1.8%).

Janssen Inc. Recalls One Lot of Ortho-Cept Tablets (28 Day)

Health Canada is advising consumers that Janssen Inc. is recalling one lot of Ortho-Cept tablets (28 day), an oral contraceptive, due to the potential low potency of the two active ingredients. This may result in reduced effectiveness of the product and in some cases, a possible risk of unplanned pregnancy. The risk associated with an unplanned pregnancy is higher for certain groups of women, such as those who have been advised against becoming pregnant for medical reasons or women who have been advised not to use very low dose formulations. DIN: 02042533, strength: 0.15 mg of  desogestrel and 0.03 mg ethinyl estradiol, exp. Date: Setember 2015. Who is affected: consumers who have purchased or used Ortho-Cept tablets (28 day), lot 13DM732. What consumers should do: if consumers are unable to determine the lot number of medication, contact the pharmacy from where it was received to confirm the lot number; speak to healthcare provider about an alternative oral contraceptive as Ortho-Cept is being discontinued and will no longer be available on the Canadian market; use another form of reliable contraception and discontinue the use of the Ortho-Cept once consumer is safely switched over to the alternative; return unopened packages to pharmacist; report any adverse events to Health Canada. Health Canada is monitoring the recall and the implementation of appropriate corrective and preventative actions by Janssen Inc. Should new information be identified, Health Canada will update Canadians.

Ontario Institute for Cancer Research Extends Collaboration with Janssen Inc. to Develop Clinical Trials for Prostate Cancer

The Ontario Institute for Cancer Research (OICR) is extending its collaborative research partnership with Janssen Inc. to develop more multi-centre clinical trials and other translational research projects that address important clinical questions in prostate cancer. The new funds will be made available to qualifying researchers at cancer centres across Canada who are addressing important clinical questions in prostate cancer. The funding will be dispersed to researchers through the Canadian Cancer Clinical Trials Network, which is based at OICR, through an open application process.

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