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Talecris Biotherapeutics Launches Talents: Talecris New Trials Support Program
Annual million-dollar grant program to fund basic and clinical research involving use of intravenous immunoglobulin
RESEARCH TRIANGLE PARK, N.C. (May 3, 2006) – Talecris Biotherapeutics today announced the launch of Talents, the Talecris New Trials Support program, an initiative supporting investigator-initiated trials conceived by researchers and clinicians with an interest in intravenous immunoglobulin (IGIV) therapies. Each year, Talecris will pledge $1 million to fund basic science and clinical research projects in various fields, including immunology, hematology, and neurology. Talecris produces and markets Gamunex®, a leading IGIV therapy, and the Talents program is another example of its ongoing commitment to the IGIV community.
"Talecris Biotherapeutics is committed to advancing standards of care involving biotherapeutic products such as IGIV," said Alberto Martinez, M.D., President and CEO of Talecris Biotherapeutics. "Through the Talents program, we will support the intellectual endeavors of the IGIV research community in a way that complements our own innovative in-house research. Together, we expect to add significantly to the scientific body of knowledge about disease mechanisms effectively treated by IGIV and, ultimately, to improve patient care."
All information about the program, including how to apply, is available on the Talents Web site, www.talecristalents.com. The application process will be conducted entirely over the Internet, with application forms available for download on the Web site.
Dr. Marinos C. Dalakas, Chief of the Neuromuscular Diseases Section of the National Institute of Neurological Disorders and Stroke in Bethesda, M.D., called the Talents program an important and reliable addition to available resources for basic researchers and clinicians. "Talents will significantly increase opportunities for the scientific and clinical community to conduct research leading to improvements in care for patients who require IGIV therapy. This program will provide information to increase our understanding of the efficacy and mechanism of action of IGIV for current clinical uses, as well as explore potential additional therapeutic applications."
The Application Process (www.talecristalents.com)
Applications will be welcomed from any individual with an M.D., Ph.D., D.O., or Pharm.D. affiliated with facilities such as universities, hospitals, clinics, blood centers, and laboratories that utilize IGIV in basic or clinical research settings or to treat patients.
Interested applicants will first submit a letter of intent, broadly outlining the background and aims of their proposed project, no later than August 15, 2006. Applicants whose letters of intent are approved will then be invited to submit a full proposal, due in mid-October. The Talents Evaluation Committee (TEC), a group composed of experts in neurology, immunology, and hematology (and other disciplines as needed), as well as Talecris scientists, will be responsible for considering both the letters of intent and the full proposals. Each application will be considered based on scientific merit, the quality of the applicant, the quality of the research environment, and the alignment of the proposed work with the goals of the Talents program. The first awards will be announced early in 2007.
"We have worked to make the application process as simple as possible," said Rene McRogers, Deputy Director of Scientific Relations and Communications and Talents Program Chair at Talecris Biotherapeutics. "We look forward to receiving the first round of applications."
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.
Contact:
Lacy McMahon
Tel.: 919.316.6316, Fax: 919.316.6673
E-mail: lacy.mcmahon@talecris.com
About Talecris Biotherapeutics
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 of approximately $1 billion in 2005, is headquartered in biotech hub Research Triangle Park, N.C. and employs more than 1,800 talented people. 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.
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