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FDA Approves Celgene Corporation (CELG)'s VARIZIG®


1/9/2013 7:07:23 AM

WINNIPEG , AB, Jan. 8, 2013 /CNW/ - Cangene Corporation ("Cangene") today announces that the United States Food and Drug Administration has approved VARIZIG® [Varicella Zoster Immune Globulin (Human)] for post-exposure prophylaxis of varicella (chickenpox) in high risk patient groups including immunocompromised children, newborns and pregnant women. VARIZIG is intended to reduce the severity of chickenpox infections in these patients.

VARIZIG is a hyperimmune product that contains antibodies specific for the Varicella zoster virus which causes the viral infection known as chickenpox. VARIZIG is approved in Canada and was previously made available in the United States under an investigational new drug (IND) Expanded Access Protocol. Through the expanded access program, VARIZIG was available for patients at risk of severe complications of varicella, to address the unmet need in this population. The Expanded Access Protocol will remain active until commercial product is available for distribution which is expected in early March of 2013. VARIZIG will continue to be distributed exclusively by FFF Enterprises, Inc., a leading biopharmaceutical supplier.

"The approval of VARIZIG in the United States marks an important milestone in Cangene's history" says John A. Sedor, President and Chief Executive Officer of Cangene. "While VARIZIG services a small niche infectious disease market, the approval of the product in the United States adds a fourth product to our commercial portfolio and reflects our patient focused strategy by addressing an ongoing medical need" added Mr. Sedor .

In the United States , for full Prescribing Information for VARIZIG, please go to: http://cangenemedicalservices.com/downloads/VARIZIG_PI.pdf

In Canada , for the VariZIG Product Monograph, please go to: http://www.cangene.com/VariZIG.

About VARIZIG® [Varicella Zoster Immune Globulin (Human)]

VARIZIG® [Varicella Zoster Immune Globulin (Human)] is a sterile freeze-dried gamma globulin (IgG) fraction of human plasma containing antibodies to varicella zoster virus (anti-VZV). Varicella zoster virus (VZV) is the causative agent of chickenpox. VARIZIG is manufactured from plasma collected from healthy, screened donors with high titres of anti-VZV which is purified by an anion-exchange column chromatography method.

Important Safety Information about VARIZIG® [Varicella Zoster Immune Globulin (Human)]

In patients who have severe thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections, only administer VARIZIG if the expected benefits outweigh the potential risks. Thrombotic events may occur following treatment with VARIZIG and other immune globulin products. Individuals known to have severe, potentially life-threatening reactions to human globulin should not receive VARIZIG or any other immune globulin (Human). Individuals who are deficient in IgA may have the potential for developing IgA antibodies and have severe, potentially life-threatening allergic reactions. Products made from human plasma may carry a risk of transmitting infectious agents, e.g. viruses and, theoretically, the Creutzfeldt-Jakob disease agent. The most common adverse drug reactions observed in clinical trials for all subjects and patients were injection site pain, headache, chills, fatigue, rash and nausea.

About Cangene Corporation

Cangene Corporation (CNJ.TO), headquartered in Winnipeg , Canada , is one of the nation's oldest and largest biopharmaceutical companies. It is focused on the development and commercialization of specialty therapeutics. Cangene's products are sold worldwide and include products that have been accepted into the U.S. Strategic National Stockpile. Cangene has offices in three 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 also operates a plasma-collection facility in Winnipeg , Manitoba under the name Cangene Plasma Resources. Its U.S. sales and marketing office is located in Philadelphia , Pennsylvania. For more information about Cangene, visit the Company's website at www.cangene.com.

About FFF Enterprises, Inc.

Temecula-based FFF Enterprises is the largest distributor of plasma products, vaccines and other biopharmaceuticals in the U.S. Founded in 1988, FFF is now in its 24th year with more than a billion dollars in annual sales. FFF has taken a leadership position in regard to supply chain safety and innovation, setting new standards and pioneering industry firsts. FFF's commitment to Guaranteed Channel Integrity™ ensures that products are purchased only from the manufacturer and shipped only to healthcare providers, with additional steps taken to safely store, handle and ship products to ensure patient safety is never compromised. FFF's proprietary systems, Verified Electronic Pedigree™ and Lot-Track™, provide verification of this secure channel, and FFF's MyFluVaccine (www.MyFluVaccine.com and VaxAmerica www.VaxAmerica.com) are revolutionary vaccination programs that have added a new level of safety, convenience and reliability to both healthcare providers and consumers. For more information about FFF Enterprises, Inc., visit the Company's website at www.fffenterprises.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; decisions by Health Canada , the United States Food and Drug Administration and other regulatory authorities regarding whether and when to approve drug applications that have been or may be filed, as well as their decisions regarding labeling and other matters that could affect the availability or commercial potential of drug candidates; 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.

SOURCE: Cangene Corporation

Contact:

Contact Information

Francis J. St.Hilaire

Vice President, General Counsel & Secretary

Ph: (204) 275-4540

Email: fsthilaire@cangene.com


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