GTC Biotherapeutics (fka GTCB)

[DewDiligence]

The main plasma-derived AAT GTC hopes to supplant has
been on the market for 20 years. This cheesy PR from Talecris
is to celebrate the 20th anniversary of the product launch.

http://biz.yahoo.com/bw/080221/20080221005173.html

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Talecris Biotherapeutics Celebrates 20th Anniversary of Launch of Prolastin®

Thursday February 21, 9:10 am ET

Milestone for market-leading Alpha-1 treatment marked by expanding commitment to advancing future improvements in patient care

RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--Talecris Biotherapeutics, Inc. (http://www.talecris.com), a leading global biotherapeutics and biotechnology company, is celebrating the 20th anniversary of the launch of Prolastin® (Alpha1-Proteinase Inhibitor [Human]). Prolastin is the market leader among alpha1-antitrypsin (AAT) augmentation therapies and is used to treat people with AAT deficiency, or Alpha-1, who have developed emphysema as a result of low circulating levels of AAT. AAT deficiency is an inherited condition thought to affect as many as 150,000 people in North America and Europe, although only an estimated five percent have been diagnosed. Prolastin was the first plasma-derived AAT augmentation therapy to receive approval from the U.S. Food and Drug Administration (FDA). Approved in December 1987, and launched in February 1988, Prolastin was the first FDA-approved product for AAT augmentation therapy for Alpha-1 patients and remained so for nearly 17 years. [This sentence doesn’t make sense, but I understand what they mean.]

Knowledge gained from clinical experience and scientific studies with Prolastin during the last 20 years has significantly advanced the care of Alpha-1 patients. “Talecris has been committed to increasing our understanding of Alpha-1 and its treatment,” said John W. Walsh, Chief Executive Officer and Co-Founder of the Alpha-1 Foundation. “Moreover, their significant contributions to the Alpha-1 community have allowed us to identify thousands of individuals with this genetic condition and increase awareness of Alpha-1, allowing families to learn to prevent this disease and to receive effective treatment when appropriate.”

Before Prolastin was approved, people with Alpha-1 received only supportive therapy for their pulmonary symptoms but did not have access to a specific therapy that raises AAT (anti-elastase) levels above the protective threshold to preserve lung function. “Prolastin has made a significant difference in my life,” said Diane Dietsche, who has received Prolastin continuously since 1989. “It is reassuring to know that Talecris remains committed to the Alpha-1 community and, most importantly, is focusing on looking for the next major breakthroughs to continue to improve patients’ lives.”

Building on the accumulated knowledge and experience of 20 years of clinically proven safety and efficacy, as demonstrated by more than two million patient infusions of Prolastin, Talecris is aggressively pursuing additional technologies to further improve patient convenience and advance care. Under development, and not yet approved by the FDA, are new manufacturing processes that may lead to products that improve convenience through reduced infusion time and may also lead to the development of an aerosol formulation. To this end, Talecris has entered into an exclusive partnership with Activaero for use of the AKITA2 APIXNEB inhalation system in the development of aerosolized AAT therapy.

“Clearly, 20 years is an important milestone that should be celebrated, but so much more remains to be done if we expect to remain the leading corporate citizen supporting the Alpha-1 community,” said Lawrence D. Stern, Chairman and CEO, Talecris Biotherapeutics, Inc. “As the largest fractionator and manufacturer of AAT augmentation therapy, we continue our investments in internal research and development that may lead to new and more convenient therapy delivery options for patients. And as we go, we will continue our ongoing dialogue with the communities we serve, seeking knowledge and inspiration that drive our work.”

Grant programs such as the Talecris Biotherapeutics Alpha-1 Research Initiative and the European Alpha-1-Antitrypsin Laurell’s Training Award (eALTA), which support basic and clinical research and education through grants provided to early career investigators, fellows-in-training, and other Alpha-1 health care professionals, are continuing. Recently, supported by an unrestricted charitable contribution from Talecris, the Alpha-1 Foundation and the American Association for Respiratory Care announced the initiation of a screening study of 5,000 patients with chronic obstructive pulmonary disease (COPD) to determine if Alpha-1 deficiency is the cause of their COPD. “These are the kinds of programs and services you can continue to expect from Talecris as we look forward to the next 20 years,” said Mr. Stern.

About Prolastin®

Prolastin is indicated for chronic augmentation therapy of individuals having congenital deficiency of alpha-1 proteinase inhibitor with clinically demonstrable panacinar emphysema. Individuals with selective IgA deficiencies who have known antibody against IgA should not receive Prolastin, since these patients may experience severe reactions, including anaphylaxis, to IgA which may be present.
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