Readers are referred to the cautionary notes regarding Forward-looking Information and non-IFRS Financial Measures at the end of this release. Unless noted otherwise, all dollar amounts are in U.S. dollars.
WINNIPEG, May 29, 2012 /CNW/ - Cangene Corporation today announces that it has initiated a voluntary product recall for eight finished product lots of HepaGam B® [Hepatitis B Immune Globulin Intravenous (Human)] that were made from a single manufacturing bulk lot. Cangene is initiating this voluntary recall as a precautionary measure due to measurable levels of procoagulant activity in HepaGam B® presenting a potential risk of adverse thrombotic reactions. To date, no adverse reactions or product complaints have been reported or associated with the use of HepaGam B®.
The HepaGam B® voluntary recall affects product distributed in Canada, United States and Israel and involves approximately 15,000 vials. Cangene is requesting that the use of these finished product lots be immediately discontinued and the product be returned to the Company. Cangene has voluntarily initiated this recall to ensure that its products continue to meet the Company's high quality standards. The safety of patients is Cangene's first priority.
The lot numbers for the eight finished product lots of HepaGam B® which are being recalled from the single manufacturing bulk lot are as follows: 11006960, 11006961, 11107308, 11107359, 11107360, 11007107, 11007148 and 11007151.
Reporting Adverse Reactions to Cangene Corporation
Adverse reactions that may be related to the use of the product may be reported, and medical inquires or questions related to product distribution may be made, to Cangene Pharmacovigilance at 1-800-768-2304. Please provide the lot number(s) of products associated with reported adverse reactions whenever possible.
Reporting Adverse Reactions to the FDA
Adverse reactions that may be related to the use of the product may also be reported to the U.S. Food and Drug Administration as follows:
- by calling 1-800-FDA-1088,
- online at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm, or
- by mail, using the MedWatch FDA 3500 postage-paid form, to the FDA Safety Information and Adverse Event Reporting Program, 5600 Fishers Lane, Rockville, MD 20852-9787.
Reporting Adverse Reactions to Health Canada
Adverse reactions that may be related to the use of the product may also be reported to the Canada Vigilance Program as follows:
- report online at www.healthcanada.gc.ca/medeffect,
- call toll-free at 1-866-234-2345, or
- complete a Reporting Form and:
- fax toll-free to 1-866-678-6789, or
- mail to: Canada Vigilance Program
Postal Locator 0701E
Ottawa, Ontario K1A 0K9
The Reporting Forms, postage paid labels, and Guidelines can be found on the MedEffectTM Canada Web site in the Adverse Reaction Reporting section. http://www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/index-eng.php
In the United States, for Full Prescribing Information for HepaGam B®, please go to: http://www.hepagamb.com/pdf/HepaGamBPI.pdf
In Canada, for the Product Monograph for HepaGam B®, please go to: http://www.cangene.com/HepaGam-B#
About HepaGam B® [Hepatitis B Immune Globulin Intravenous (Human)]
HepaGam B® [Hepatitis B Immune Globulin Intravenous (Human)] is a hyperimmune product containing antibodies specific for hepatitis B virus. The product is approved in Canada, the United States, Israel and Kuwait for treating acute exposure to the hepatitis B virus (post-exposure prophylaxis or PEP) and for preventing re-infection in liver transplant recipients who are positive for hepatitis B infection (NOC with conditions in Canada). HepaGam B® is the first hepatitis B immune globulin to receive approval in Canada and the United States for both the PEP and liver transplant indications.
About Cangene Corporation
Cangene Corporation (TSX: CNJ), headquartered in Winnipeg, Canada, is one of the nation's oldest and largest biopharmaceutical companies focused on the development and commercialization of immune therapeutics. Cangene's products are sold worldwide and include products that have been accepted into the U.S. Strategic National Stockpile. Cangene has approximately 580 employees in six locations across North America. It operates manufacturing facilities in Winnipeg, Manitoba and Baltimore, Maryland (through its wholly-owned subsidiary Cangene bioPharma, Inc.) where it produces its own products and undertakes contract manufacturing for a number of customers. Cangene operates three U.S. and one Canadian plasma-collection facilities operating under the name Cangene Plasma Resources. For more information about Cangene, go to the Company's website at: www.cangene.com.
Cautionary note regarding Forward-looking Information
This document contains forward-looking statements about the Corporation, including its business operations, strategy, and expected financial performance and condition. Forward-looking statements include statements that are predictive in nature, depend upon or refer to future events or conditions, or include words such as "expects", "anticipates", "intends", "plans", "will", "believes", "estimates", or negative versions thereof, and similar expressions. In addition, any statement that may be made concerning future financial performance (including revenues, earnings or growth rates), ongoing business strategies or prospects, future use, safety and efficacy of unapproved products or unapproved uses of products, and possible future action by the Corporation are also forward-looking statements. Forward-looking statements are based on current expectations and projections about future events and are inherently subject to, among other things, risks, uncertainties and assumptions about the Corporation, economic factors and the biopharmaceutical industry generally. They are not guarantees of future performance. Actual events and results could differ materially from those expressed or implied by forward-looking statements made by the Corporation due to, but not limited to, important factors such as sales levels, fluctuations in operating results, the Corporation's reliance on a small number of customers including government organizations, the demand for new products and the impact of competitive products, service and pricing, the availability and cost of raw materials, and in particular, the cost, availability and antibody concentration in plasma; progress and cost of clinical trials, costs and possible development delays resulting from use of legal, regulatory or legislative strategies by the Company's competitors, uncertainty related to intellectual property protection and potential costs associated with its defence as well as general economic, political and market factors in North America and internationally, interest and foreign exchange rates; business competition; technological change, changes in government action, policies or regulations, changes in accounting policies and the effect of applying future accounting policy changes required under IFRS, unexpected judicial or regulatory proceedings, catastrophic events, the Corporation's ability to complete strategic transactions, and other factors beyond the control of management.
The reader is cautioned that the foregoing list of important factors is not exhaustive and there may be other factors listed in other filings with securities regulators, including factors set out under "Risk and Uncertainties" in the Corporation's Management Discussion and Analysis, which, along with other filings, is available for review at www.sedar.com. The reader is also cautioned to consider these and other factors carefully and not to place undue reliance on forward-looking statements. Other than as specifically required by applicable law, the Corporation has no intention to update any forward-looking statements, whether as a result of new information, future events or otherwise.
Cautionary Note Regarding Non-IFRS Financial Measures
This news release may contain non-IFRS financial measures. Terms by which non-IFRS financial measures are identified include but are not limited to "net cash", "total assets", "sales" and other similar expressions. Non-IFRS financial measures are used to provide management and investors with additional measures of performance. However, non-IFRS financial measures do not have standard meanings prescribed by IFRS and are not directly comparable to similar measures used by other companies. Please refer to the appropriate reconciliations of these non-IFRS financial measures to measures prescribed by IFRS.
For further information:
John A. Sedor
President and Chief Executive Officer
Ph: (204) 275-4201