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Talecris Names Inaugural Talents Grant Recipients

Program funds basic and clinical research programs involving intravenous immunoglobulin therapies

RESEARCH TRIANGLE PARK, N.C. (January 4, 2007) – Seven scientific investigators and clinicians from research institutions around the world are the first recipients of the Talents Awards initiated by Talecris Biotherapeutics, Inc. The awarded grants support investigator-initiated trials conceived by researchers and clinicians with an interest in intravenous immunoglobulin (IGIV) therapies. Talents (Talecris New Trials Support) is designed to further advance research that addresses the use of IGIV in antibody replacement as well as immune modulation therapies. Talecris produces and markets Gamunex® (Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified), a leading IGIV therapy.

The seven 2006 winners represent three countries including the United States, Canada, and the United Kingdom. “When we announced this program in May, we committed $1 million yearly to support external basic science and clinical research projects complementary to our own innovative in-house research,” said Alberto Martinez, M.D., President and CEO of Talecris Biotherapeutics. “The Talents program is an important source of research funding for the IGIV community, and another opportunity for Talecris to demonstrate our ongoing commitment to further advancing knowledge and insights leading to improved patient outcomes.”

The inaugural Talent grants will fund a variety of studies ranging from basic cellular mechanisms by which IGIV mediates immune response, to a multicenter clinical registry to establish the efficacy of IGIV in patients with chronic inflammatory demyelinating polyneuropathy (CIDP) who do not meet normal diagnostic criteria.

Investigators receiving this year’s Talents grants are:
  • Dr. Regine Mydlarski, University of Calgary, Calgary, Canada: “A randomized double-blind, placebo controlled trial to assess the safety and efficacy of intravenous immunoglobulin in the treatment of pemphigus vulgaris.”
  • Dr. Melvin Berger, Children’s Research Foundation of Cleveland, Cleveland, Ohio: “Subcutaneous versus intravenous immune globulin treatment in animal models of neuromuscular disease.”
  • Dr. Andreas Goebel, Department of Clinical Neurology, University of Oxford, Oxford, United Kingdom: “Intravenous immunoglobulin in the treatment of primary trigeminal neuralgia refractory to carbamazepine (IGIV in TN).”
  • Dr. David Scott Saperstein, Phoenix Neurological Associates, Phoenix, Arizona: “Database of immune-mediated neuropathy treatment outcomes.”
  • Dr. Frederick Goldman, University of Iowa Hospitals and Clinics, Iowa City, Iowa: “Immunomodulatory properties of IGIV in developing immune systems post hematopoietic stem cell transplant.”
  • Dr. Mieko Toyoda, Transplant Immunology Laboratory, Cedars-Sinai Medical Center, Los Angeles, California: “Development of novel assays to monitor human B-cell responses to alloantigens in patients undergoing desensitization with IVIG. Relationship to antibody mediated rejection and responses to IVIG therapy.”
  • Dr. Vera Bril, University Health Network, University of Toronto, Toronto, Ontario, Canada: “A randomized trial of plasma exchange compared with IVIG in the treatment of Myasthenia Gravis.”



The Talents Evaluation Committee, comprised of experts in neurology, immunology, and hematology, as well as Talecris scientists, received more than 50 letters of intent in its inaugural year. “We were extremely impressed with the quality of the grant submissions,” said Rene McRogers, Deputy Director of Scientific Relations and Communications and Talents Program Chair at Talecris Biotherapeutics. “We look forward to the results that will come from these research projects and the impact they will have to increase our understanding of disease processes and clinical care.”

Disbursements of grants will begin in early January, 2007. Talecris will begin accepting letters of intent for the 2007 awards in August, 2007. All information about the program, including how to apply, is available on the Talents Web site, www.talecristalents.com.

For more information, contact:
Lacy McMahon, Talecris Biotherapeutics
Tel.: 919.316.6316, Fax: 919.316.6673
E-mail: lacy.mcmahon@talecris.com


About Gamunex®
Gamunex® is a lifesaving IGIV therapy that contains antibodies purified from the donated blood plasma of thousands of people and is used to treat a variety of health problems, both as a means of immune replacement and for modulating the immune system. Gamunex® is indicated as replacement therapy of primary humoral immunodeficiency disease (PI) and as immunomodulatory therapy for idiopathic thrombocytopenic purpura (ITP).

Important Safety Information
Gamunex® is contraindicated in individuals with known anaphylactic or severe systemic response to Immune Globulin (Human). Immune Globulin Intravenous (Human) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis and death. Patients should be instructed to immediately report symptoms of decreased urine output, sudden weight gain, fluid retention/edema, and/or shortness of breath (which may suggest kidney damage) to their physicians. While these reports of renal dysfunction and acute renal failure have been associated with the use of many of the licensed IGIV products, those containing sucrose as a stabilizer accounted for a disproportionate share of the total number. Gamunex® does not contain sucrose. Glycine, a natural amino acid, is used as a stabilizer.

There have been reports of noncardiogenic pulmonary edema, rare reports of hemolytic anemia, and very rare reports of aseptic meningitis in patients administered with IGIV. Thrombotic events have been reported in association with IGIV. Patients at risk may include those with a history of atherosclerosis, multiple cardiovascular risk factors, advanced age, impaired cardiac output, and/or known or suspected hyperviscosity. 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 on Gamunex®, please see Full Prescribing Information at www.gamunex.com.

About 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, 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, which earned revenues exceeding $1 billion through the year ending June 30, 2006, is headquartered in biotech hub Research Triangle Park, N.C., and employs more than 3,000 talented people worldwide.

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



 

 

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