RESEARCH TRIANGLE PARK, N.C.–(BUSINESS WIRE)–Aug 2, 2007 – In response to evolving needs expressed by the patient community and healthcare providers, effective immediately, Talecris Biotherapeutics, Inc. (http://www.talecris.com) has implemented a Portability Policy for Gamunex(R). This policy better reflects and responds to current market dynamics by accommodating changes in customer relationships, sites of service and points of care. Talecris’ goal in implementing the Portability Policy for Gamunex is to help ensure patients who rely upon Gamunex continue to receive it reliably and at their preferred location in situations where their product supply channels or sources of distribution have changed.
“Patients have expressed worry and experienced frustration related to maintaining access to their IGIV of choice,” said Marcia Boyle, President and Founder, Immune Deficiency Foundation (IDF). “This new Portability Policy for Gamunex demonstrates Talecris’ ongoing commitment and leadership, and is consistent with IDF’s goals to ensure reliable access to life-saving treatment for patients.”
Results from a recent Harris Interactive(R)(1) survey showed that Gamunex is the preferred liquid immune globulin intravenous (IGIV) among allergists and immunologists. “We are keenly aware that many professionals prefer Gamunex,” said Alberto Martinez, M.D., President and Chief Operating Officer, Talecris Biotherapeutics. “With this new policy, we will help eliminate barriers and facilitate the accessibility of life-saving therapy to those patients who rely on Gamunex. Quite simply, we want this policy to help ensure patients have access to Gamunex, both when and where they need it.”
To help ensure continuing availability of Gamunex, there are several delivery options for patients and their physicians that will result in fewer treatment disruptions. Although the exact details of the portability process vary from customer to customer and are subject to various conditions, purchases of Gamunex generally can be transitioned from one Talecris-contracted organization to another, or to a direct contract with Talecris. Certain aspects of the new policy and process details will be administered by an independent third party under contract with Talecris. Additionally, Talecris will continue to rely on the expertise of its four authorized strategic channel distribution partners – ASD Healthcare, Blood Diagnostics, Inc. (BDI), Cardinal Specialty and FFF Enterprises.
Bryant Mangum, Vice-President of Pharmacy Services for Premier, Inc., a hospital performance improvement alliance that includes GPO services, commented on the value of the new Portability Policy for Gamunex. “We applaud this move by Talecris because it will help us meet patient needs, and further ensures access for patients served by our 1,700 member providers nationwide.”
In addition to Gamunex, the new Portability Policy also applies to the Talecris albumin products Plasbumin(R) (Albumin (Human)) and Plasmanate(R) (Plasma Protein Fraction (Human)).
Talecris’ Comprehensive Commitment to Ensure Access to Gamunex
As a leading provider of liquid IGIV products for more than 25 years, Talecris works diligently to ensure reliable access to its products. To meet the high demand for Gamunex, Talecris has significantly increased production of Gamunex since its launch in 2003 by maximizing output from its 100 percent dedicated state-of-the-art manufacturing facility; and now the Portability Policy will further improve consistent, reliable access to Gamunex. Talecris’ network of plasma collection centers helps to ensure they maintain a reliable and safe supply of plasma – the starting material for their products. As a result, Talecris is well-positioned to provide a reliable, continuous supply of Gamunex to meet customer needs well into the future.
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 about Gamunex, please see http://www.gamunex.com for Full Prescribing Information.
Results demonstrating preference for Gamunex among liquid IGIV brands included within an overall list of leading liquid and non-liquid IGIV brands are statistically significant with a 95% confidence interval (indicating that there is no more than a five in 100 chance that the observed differences could have been obtained by chance) and are based on a blinded, national survey of 358 allergists/immunologists from the AMA Physician Master List. The survey was conducted by Harris Interactive(R) on behalf of Talecris Biotherapeutics from December 17, 2006 to January 9, 2007. In order to qualify to complete the survey, the allergists/immunologists must have been in practice for at least one year, be active prescribers of IGIV, and be aware of at least two brands of IGIV. Respondents were asked to assume no difference in terms of availability, cost, and reimbursement when indicating their most preferred IGIV brand. The survey was conducted and the results were validated by a reputable, independent, third-party, Harris Interactive(R), a worldwide market research and consulting firm best known for the Harris Poll(R).
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 $1.1 billion in 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 http://www.talecris.com.
(1) Preference results for Gamunex based on blinded national survey of 358 allergists/immunologists from AMA Physician Master List choosing from a list of leading liquid and non-liquid IGIV brands. Survey was conducted by Harris Interactive from Dec. 2006 to Jan. 2007, and the results are statistically significant at p less than or equal to 0.05.
Talecris Biotherapeutics, Inc.
Lacy McMahon, 919-316-6316
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