FFF Enterprises Named Exclusive Distributor of Cangene’s VARIZIG®
Press Release for February 28, 2013 - Download
The recently FDA-approved hyperimmune is for post-exposure prophylaxis of high-risk individuals exposed to the chickenpox virus.
Temecula, Calif – FFF Enterprises, Inc. announced today that it will remain the exclusive distributor for VARIZIG [Varicella Zoster Immune Globulin (Human)], a hyperimmune manufactured by Cangene Corporation. VARIZIG is indicated 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. It is the only FDA-approved immune globulin for chickenpox, after exposure, available in the United States. FFF also partnered with Cangene as sole distributor of VARIZIG during its investigational new drug (IND) Expanded Access Protocol and clinical trial phases.
According to the Centers for Disease Control and Prevention (CDC), immune-compromised individuals who contract chickenpox are at risk of developing severe complications that can be fatal. Pregnant women who contract the virus are at increased risk for developing pneumonia, and becoming infected early in pregnancy can put their newborns at risk for low birth weight and birth defects, including limb abnormalities. When an expectant mother develops chickenpox in the week before birth, the virus can result in a life-threatening infection in a newborn. In any of these instances, VARIZIG is indicated for use within four days of being exposed to the virus.
“We are very proud to continue as the exclusive distributor for this unique product,” said Patrick M. Schmidt, chief executive officer, FFF Enterprises. “VARIZIG fills a previously unmet need by providing post-exposure prophylaxis to immune-compromised patients exposed to the varicella zoster virus. Having it readily available in our product portfolio supports our mission of Helping Healthcare Care.”
For full Prescribing Information for VARIZIG, please go to: http://www.varizig.com/VariZig_prescribing_information_Jan2013.pdf.
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 25th year with more than one 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.com and 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.
About Cangene Corporation (Now Emergent Biosolutions)
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 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.
Cheryl Brooks, VP of Marketing and Communications
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