News Release

University Hospitals Case Medical Center researcher awarded

Melvin Berger, M.D., recognized for innovative intravenous immunoglobulin research in the treatment of neuromuscular disorders

Grant and Award Announcement

University Hospitals of Cleveland

Melvin Berger, M.D., Ph.D., a physician-researcher in immunology at University Hospitals Case Medical Center, is one of seven inaugural grant recipients from Talecris Biotherapeutics, Inc.'s Talents (Talecris New Trials Support) program. Berger is an expert on primary immunodeficiencies (PID) which are disorders of the immune system that make patients highly vulnerable to infections and autoimmune diseases.

The $250,000 award will help him research whether an under-the-skin pump is as effective as an intravenous drip in treating patients with neurological diseases with immune globulin. Immune globulin replaces missing antibodies in people with PID, but high doses are used to fight autoimmune diseases such as myasthenia gravis and chronic polyneuropathy. In this situation, the immunoglobulin serves to "modulate" the immune system, bringing the autoimmune process under control, according to Berger who directs the Model Diagnostic Center for Primary Immunodeficiencies at UH's Rainbow Babies and Children's Hospital.

"Giving large doses of globulin intravenously is often associated with adverse effects, but giving the same medicine under the skin has many fewer side effects, so patients can usually treat themselves at home," Berger said.

The Talents grants support research trials conceived by researchers and clinicians with an interest in intravenous immunoglobulin (IGIV) therapies. The Talecris Talents Awards are designed to help further advance research that addresses the use of IGIV as either an antibody replacement therapy or as an immune modulation therapy. Talecris produces and markets Gamunex® , a leading IGIV.

"We were extremely impressed with the quality of the grant submissions for our first Talents Awards program," said Rene McRogers, deputy director of scientific relations and communications and Talents Program chair at Talecris Biotherapeutics. "We look forward to the outcomes that will result from these research projects and to the impact the research will have in increasing our understanding of disease processes and clinical care."

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About University Hospitals

With 150 locations throughout Northeast Ohio, University Hospitals serves the needs of patients through an integrated network of hospitals, outpatient centers and primary care physicians. At the core of our Health System is University Hospitals Case Medical Center. The primary affiliate of Case Western Reserve University School of Medicine, University Hospitals Case Medical Center is home to some of the most prestigious clinical and research centers of excellence in the nation and the world, including cancer, pediatrics, women's health, orthopedics and spine, radiology and radiation oncology, neurosurgery and neuroscience, cardiology and cardiovascular surgery, organ transplantation and human genetics. Its main campus includes the internationally celebrated Rainbow Babies & Children's Hospital, ranked best in the Midwest and first in the nation for the care of critically ill newborns; MacDonald Women's Hospital, Ohio's only hospital for women; and Ireland Cancer Center, which holds the nation's highest designation by the National Cancer Institute of Comprehensive Cancer Center. For more information, go to www.uhhospitals.org.

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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