Readers are referred to the cautionary notes regarding Forward-Looking
Information at the end of this release.
WINNIPEG, 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
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 (TSX: CNJ), 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
For further information:
Francis J. St.Hilaire
Vice President, General Counsel & Secretary
Ph: (204) 275-4540