Through its approval, Gamunex is the only therapy of any kind with an approved indication for the treatment of CIDP. Gamunex now has the broadest set of Health Canada-approved indications of any liquid Immune Globulin Intravenous (IGIV) therapy. Gamunex also becomes the first and only IGIV therapy approved to treat any neurological disorder in Canada. 

“Our patients are thrilled to know that they can rely on Gamunex,” said Susan Keast, Executive Director and President of the GBS/CIDP Foundation of Canada, and Director on the board of the GBS/CIDP Foundation International. Established in 2003, the GBS/CIDP Foundation of Canada is the only voluntary, nonprofit organization that provides support to families with Guillain-Barré Syndrome (GBS) and CIDP in Canada. “For Talecris to have clearly established that Gamunex is a safe and effective treatment for patients with CIDP is exciting and gratifying. This is truly wonderful news for CIDP patients and their families who rely on this important therapy.”

Talecris is developing programs to educate neurologists on this indication and the clinical trial which proved the efficacy supporting the new indication.

“We are proud to be able to support Canadian patients and their families with the licensure of Gamunex as the first approved IGIV treatment for CIDP,” said Joel Abelson, Senior Vice President and General Manager, Portfolio Management and International Business for Talecris Biotherapeutics.  “For patients suffering from this debilitating neurological condition, Gamunex provides a safe and effective method of treatment.  It remains our goal to improve care and advance knowledge for patients who rely on our therapeutic products.” 

To secure the indication, Talecris conducted the first and only large-scale clinical trial for the treatment of CIDP.  This study validates the long-term safety and efficacy of Gamunex as a first line and maintenance treatment for CIDP.  This landmark study was published in the February 2008 issue of The Lancet Neurology.

"The ICE study was a pivotal trial in showing that Gamunex was superior to placebo in reducing functional disability and improving grip strength in CIDP patients," said Vera Bril, M.D., study co-author and Professor of Medicine and Division Director of Neurology, University Health Network/Mount Sinai Hospital.  "This was the largest trial ever conducted in CIDP and was important in showing that patients treated with Gamunex could maintain long-term benefit versus placebo and that patients who continued to receive Gamunex had a significantly longer time to relapse than did placebo trial subjects."

About CIDP
Chronic inflammatory demyelinating polyneuropathy (CIDP) is a neurological disorder often characterized by progressive weakness and impaired sensory function in the legs and arms.  This disorder is caused by damage to the myelin sheath (the fatty covering that wraps around and protects nerve fibers) of the peripheral nerves.  Signs and symptoms — which usually develop slowly over weeks and progress over several months — may include weakness of the arms, legs and face; tingling and numbness in the arms and legs (often beginning in the fingers and toes); as well as muscle aches and fatigue. CIDP, affecting two to seven individuals per 100,000 worldwide, can occur at any age and in both genders, although it is more common in elderly adults and in men.

About Gamunex
Gamunex is an IGIV therapy that contains antibodies purified from the donated blood plasma of thousands of people.  Gamunex is indicated as replacement therapy of primary immune deficiency syndromes (PID), secondary immune deficiency syndromes (SID) such as allergenic bone marrow transplantation and pediatric HIV disease, as well as immunomodulatory therapy for idiopathic thrombocytopenic purpura (ITP) and now for CIDP.

Important Safety Information
Gamunex is contraindicated in individuals with known anaphylactic or severe systemic response to Immune Globulin (Human), and those who are hypersensitive to the drug or any component or ingredient of this drug.  Individuals with severe, selective IgA deficiencies who have known antibody against IgA should only receive Gamunex with utmost cautionary measures.  IGIV products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis and death. While these reports of renal dysfunction and failure have been associated with the use of many IGIV products, those containing sucrose accounted for a disproportionate share; Gamunex does not contain sucrose.  Hemolytic anemia, hemolysis, and hemolytic reaction have been reported rarely in association with use of Gamunex and other IGIV products. There have been reports of noncardiogenic pulmonary edema, very rarely aseptic meningitis and thrombotic events in patients administered with IGIV.  The most common side effects noted during clinical trials included headache, vomiting, fever, nausea, rash, and back pain.

As with all plasma-derived therapeutics, the potential to transmit infectious agents cannot be totally eliminated. For additional information about Gamunex, please see www.gamunex.ca for Full Prescribing Information.

Talecris Biotherapeutics: Inspiration. Dedication. Innovation.
Talecris Biotherapeutics is a global biotherapeutic and biotechnology company that discovers, develops and produces critical care treatments for people with life-threatening disorders in a variety of therapeutic areas including immunology, pulmonology, neurology, and hemostasis.  Talecris is proudly building upon a 60-year legacy of innovation and a commitment to improving the lives of people who rely on its therapeutic products.  With an emphasis on scientific inquiry and technological excellence, Talecris is expanding its current portfolio of products, programs, and services through its own world-class product development organization as well as through strategic initiatives that leverage its strengths with those of its partners.

Talecris, with revenues of approximately $1.2 billion in 2007, is headquartered in biotech hub Research Triangle Park, N.C., and employs more than 4,000 talented people worldwide.

To learn more about Talecris and how its employees are making a difference in the lives of patients and the healthcare community, visit www.talecris.com.

Contact:
Wendy Wilson
Tel.: 919.316.2430, Fax: 919.316.6377
E-mail: wendy.wilson@talecris.com