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Media Center Overview
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Talecris Biotherapeutics Reaffirms Commitment to Set Industry Standard for Product Integrity
Latest moves to streamline distribution and enhance packaging safety illustrate Talecris' comprehensive approach to the drug tampering and counterfeiting challenge
RESEARCH TRIANGLE PARK, N.C. (June 16, 2005) – Talecris Biotherapeutics announced today a number of measures in the areas of packaging safety and supply chain integrity. These steps underscore the company's ongoing commitment to being a leader within the biological products industry when it comes to protecting patients against product tampering and counterfeiting.
This month marks the launch of Talecris brand labeling on Gamunex® (Immune Globulin Intravenous [Human], 10%, Caprylate/Chromatography Purified). The new company logo will appear on the vial label, carton, package insert, and clear plastic shrink-banding covering the neck and lid of the bottle. The shrink-band also comes with a pull-tab for easy removal. If tampering has occurred, the shrink-band will be broken or loosened, and the disruption will be obvious to the naked eye. The addition of the Talecris logo on the shrink-banding makes the casing difficult to duplicate.
Talecris also announced it has reduced the number of its full-line distributors by almost half, to fewer than 10 distributors. Talecris' detailed contracts with its remaining distributors will further enhance Talecris' efforts to ensure that its products are distributed only through approved channels. In addition to maintaining its ability to inspect distributor facilities and audit records at will, Talecris will also require distributors to provide more detailed reporting on product disposition, along with a monthly inventory reconciliation. This approach enhances the level of security of the supply chain and helps Talecris deliver on its commitment to patient safety.
Talecris intends to be the recognized global leader in developing and delivering premium protein therapies, and is committed to growing and strengthening measures to ensure the integrity of its products. "A legacy of safety has been underscored through these comprehensive leadership efforts in the area of packaging safety," said Melissa Schweitzer, Patient Advocacy and Genetic Services Director of the Immune Deficiency Foundation. "Patients notice and appreciate these efforts in response to the growing threat of tampering and counterfeiting, and we are excited that Talecris will continue the commitment to maintaining product integrity."
These latest innovations by Talecris Biotherapeutics to prevent product tampering and counterfeiting further strengthen efforts initiated by the company's predecessor, Bayer Biological Products. Talecris takes a multi-phased approach to product tampering and counterfeiting which is characterized by two overarching strategies. First, recognizing the ongoing threat, the company utilizes currently available packaging options such as shrink-banding, tamper-evident labeling, and tamper-evident cartons. Talecris also is exploring application of new technologies. Second, agreeing with the FDA's finding that there is no single "silver bullet" to countering the counterfeit challenge, Talecris continues to act on other fronts, such as patient outreach and education, supply chain security measures, and support of FDA initiatives in this area.
"Talecris will continue to be vigilant about providing safe, high-quality plasma-based products to our patients," said Talecris Executive Chairman Larry Stern. "We will maintain our multi-faceted approach to product integrity and continue to evaluate new options. We want to make sure patients and treaters who use our products can easily recognize if a product has been compromised in any way."
Each Talecris product is equipped with tamper-evident labeling. A counterfeiter would find the label difficult to remove without tearing or leaving behind a residue. Each Gamunex® (Immune Globulin Intravenous [Human], 10%, Caprylate/Chromatography Purified) label contains a color-coded tracking tab which adds to the label's level of sophistication, increasing the challenge for would-be counterfeiters. The edge of the product label contains a peel off color-coded flag tab indicating the vial size and strength, product lot number and manufactured date. Also, effective immediately, each vial of Gamunex® is equipped with a bar code that can be used to link the product to the patient's chart, helping to ensure that each patient receives the proper medication and to minimize potential error by the healthcare provider.
Contact:
Lacy McMahon
Tel.: 919.316.6316, Fax: 919.316.6673
E-mail: lacy.mcmahon@talecris.com
About Talecris Biotherapeutics
Talecris is a newly formed company with the assets and history of Bayer HealthCare Biological Products Division's plasma business. With global headquarters in Research Triangle Park, N.C., primary manufacturing facilities for Talecris products in Clayton, N.C., and additional fractionation and manufacturing facilities of Precision Pharma Services in Melville, N.Y, Talecris employs nearly 1700 people.
Inheriting a legacy of more than 60 years of providing lifesaving and life-enhancing plasma-derived therapeutic proteins, Talecris is well positioned to become recognized as the global leader in developing and delivering premium protein products. Through its people, technology, and state-of-the-art facilities, Talecris will build on this long history of innovation through a focused, entrepreneurial approach to new product development, application of cuttingedge manufacturing technologies, and marketing and customer service. Talecris is talented industry professionals providing critical care treatments and services for patients, while maintaining a vision for the future of care.
Information about Talecris can be found at www.talecris.com.
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