Gamunex(R) is the Preferred IGIV Therapy of Neurologists

RESEARCH TRIANGLE PARK, N.C., April 12 /PRNewswire-FirstCall/ -- Talecris Biotherapeutics, Inc., today announced results of a new survey showing that Gamunex® (Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified) is the preferred immune globulin intravenous (IGIV) among neurologists who indicated a brand preference. In the survey, conducted online by Harris Interactive® on behalf of Talecris, neurologists selected Gamunex over four times more often than all other available liquid IGIV therapies, with a statistically significant margin (p<0.05).

Gamunex has the broadest set of FDA-approved indications for any liquid IGIV, and it is the only therapy on the market approved to treat chronic inflammatory demyelinating polyneuropathy (CIDP), a debilitating neurologic condition that can lead to severe impairment of motor skills. Neurologists, the specialists who treat CIDP, prescribe more grams of IGIV than any other physician specialty.

"Our investment in a significant clinical trial to treat CIDP with Gamunex resulted in the first and only FDA-approved treatment for CIDP. We are particularly pleased that the clinical trial provided outcomes data for neurologists to make informed treatment decisions," said Larry Stern, chairman and CEO of Talecris Biotherapeutics. "The Harris Interactive study shows that our educational efforts are already having a positive impact on brand choice, and we look forward to providing further educational support about the clinical use of Gamunex."

Survey Methodology

Results of the Harris Interactive survey are statistically significant with a 95 percent confidence interval and are based on an online national survey of 298 neurologists selected from among the Harris Interactive online Physician Panel and the American Medical Association (AMA) database on behalf of Talecris Biotherapeutics. The survey was conducted in February 2010. In order to qualify to complete the survey, neurologists must have been in practice for at least one year, be aware of at least two IGIV products, and prescribe IGIV products, so that a true comparison between brands could be made. The data were post-weighted by gender, years in practice, and region in order to represent the AMA population of neurologists. 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 are validated by global custom research firm Harris Interactive®, known for their innovation and expert insights, as well as the renowned Harris Poll®.

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 for primary humoral immunodeficiency disease (PI), and as immunomodulatory therapy for both idiopathic thrombocytopenic purpura (ITP) and chronic inflammatory demyelinating polyneuropathy (CIDP).

Gamunex (Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified) is indicated for the treatment of primary humoral immunodeficiency disease (PI), idiopathic thrombocytopenic purpura (ITP), and chronic inflammatory demyelinating polyneuropathy (CIDP).

About Talecris Biotherapeutics: Inspiration. Dedication. Innovation.

Talecris Biotherapeutics (Nasdaq: TLCR) 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. (www.talecris.com)

Important Safety Information for Gamunex®

Immune Globulin Intravenous (Human) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis and death. Patients predisposed to acute renal failure include patients with any degree of pre-existing renal insufficiency, diabetes mellitus, age greater than 65, volume depletion, sepsis, paraproteinemia, or patients receiving known nephrotoxic drugs. Especially in such patients, IGIV products should be administered at the minimum concentration available and the minimum rate of infusion practicable. 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. 

Gamunex is contraindicated in individuals with acute severe hypersensitivity reactions to Immune Globulin (Human).  It is contraindicated in IgA deficient patients with antibodies against IgA and history of hypersensitivity.

There have been reports of noncardiogenic pulmonary edema [Transfusion-Related Lung Injury (TRALI)], hemolytic anemia, and aseptic meningitis in patients administered with IGIV.

Thrombotic events have been reported in association with IGIV. Patients at risk for thrombotic events may include those with a history of atherosclerosis, multiple cardiovascular risk factors, advanced age, impaired cardiac output, and/or known or suspected hyperviscosity. Hyperproteinemia, increased serum viscosity, and hyponatremia may occur in patients receiving IGIV therapy.

Gamunex is made from human plasma.   Because this product is made from human plasma, it may carry a risk of transmitting infectious agents, e.g., viruses, and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent.

In clinical studies, the most common adverse reactions with Gamunex were headache, fever, chills, hypertension, rash, nausea, and asthenia (in CIDP); headache, cough, injection site reaction, nausea, pharyngitis, and urticaria (in PI); and headache, vomiting, fever, nausea, back pain, and rash (in ITP).  The most serious adverse reactions were pulmonary embolism (PE) in one subject with a history of PE (in CIDP), an exacerbation of autoimmune pure red cell aplasia in one subject (in PI), and myocarditis in one subject that occurred 50 days post-study drug infusion and was not considered drug related (in ITP).

Please see accompanying Gamunex full Prescribing Information for complete prescribing details.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Cautionary statement regarding forward-looking statements

This press release contains forward-looking statements within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, quotations from management in this press release, statements regarding strategic and operation plans, and statements regarding the development or commercialization of therapies. Forward-looking statements are based on current beliefs and expectations and are subject to inherent risks and uncertainties.  You are cautioned not to place undue reliance on forward-looking statements. Although Talecris believes that the forward-looking statements contained in this press release are reasonable, there is no assurance that expectations will be fulfilled.  The following factors, among others, could cause actual results to differ materially from those expressed or implied in forward-looking statements: possible U.S. legislation or regulatory action affecting, among other things, the U.S. healthcare system, pharmaceutical pricing and reimbursement, including Medicaid and Medicare; our ability to procure adequate quantities of plasma and other materials which are acceptable for use in our manufacturing processes from our own plasma collection centers or from third party vendors; our ability to maintain compliance with government regulations and licenses, including those related to plasma collection, production and marketing; our ability to identify growth opportunities for existing products and our ability to identify and develop new product candidates through our research and development activities; and the timing of, and our ability to, obtain and/or maintain regulatory approvals for new product candidates, the rate and degree of market acceptance, and the clinical utility of our products. Additional information about factors that could affect the business and financial results of Talecris is contained in its Annual Report to the Securities and Exchange Commission on Form 10-K for the year ended December 31, 2009. Talecris undertakes no duty to update any forward-looking statement.

SOURCE Talecris Biotherapeutics, Inc.