Information Update - Sanofi Toronto Facility Update Regarding ImmuCyst

OTTAWA, July 11, 2012 /CNW/ - Health Canada has completed a thorough health risk assessment of the bladder cancer treatment ImmuCyst produced at Sanofi Pasteur's manufacturing plant in Toronto.

A Health Canada inspection of Building 86 at Sanofi Pasteur's manufacturing plant in Toronto found the presence of mould in the sterile manufacturing areas where ImmuCyst was produced.

Health Canada's review has concluded that ImmuCyst should remain available to bladder cancer patients, provided the drug continues to meet quality assurance standards. Samples from every lot of ImmuCyst will be evaluated for quality by both the manufacturer and Health Canada before being released for use by Canadians. Lots that are determined to meet specific standards will be made available as required. At this time, the information needed from Sanofi to complete the evaluation process for unreleased lots of ImmuCyst has not yet been provided to the Department.

Health Canada has also requested that Sanofi communicate directly with Canadian health care practitioners as soon as possible, to advise them of the situation.

Patients taking ImmuCyst should speak with their health care provider if they have concerns about the product. There is an authorized alternative available in Canada that treats bladder cancer.

Health Canada has already worked with Sanofi regarding its voluntary recall from the Canadian market of all Bacille Calmette-Guérin (BCG) tuberculosis vaccine produced in the same building at its Toronto facility. The Public Health Agency of Canada is taking steps to secure an alternate supply of this vaccine.

In light of the manufacturing problems at the Toronto plant, there may be a global impact on the supply of ImmuCyst. Health Canada will continue to consult with its international regulatory counterparts, including the U.S. Food and Drug Administration.

In Canada, the safe use of health products is a responsibility shared among a number of parties, including Health Canada as the regulator that reviews and monitors the safety and efficacy of products, the manufacturers that make them, physicians who prescribe them, and informed consumers. To this end, Health Canada is working with Sanofi to expedite its action plan to correct manufacturing problems at its facilities to lessen the impact on patients globally.

Consumers requiring more information about this advisory can contact Health Canada's public enquiries line at (613) 957-2991, or toll free at 1-866-225-0709.

SOURCE Health Canada

For further information:

Media Enquiries:
Health Canada
(613) 957-2983

Public Enquiries:
(613) 957-2991
1-866 225-0709

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