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[DewDiligence]

Talecris Biotherapeutics and BBI Sign Development Agreement for Alpha-1 Antitrypsin (AAT) Test

[Recombinant AAT is GTCB’s #2 drug candidate behind ATryn. This PR contains some info apropos to the size of the market for treating hereditary AAT deficiency.]

http://biz.yahoo.com/bw/050809/95549.html?.v=1

Talecris and BBI Aim to Provide Accurate, Fast Method of Testing AAT Levels

RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--Aug. 9, 2005--Talecris Biotherapeutics has entered into an exclusive agreement with BBI Holdings PLC to develop a screening tool for detecting patients' levels of Alpha-1 Antitrypsin (AAT), the naturally occurring protein that is present at low levels in individuals suffering from Alpha-1 Antitrypsin Deficiency. Current screening methods for AAT are typically performed using standard blood tests, the results of which may take days, or even weeks, to obtain. In contrast, the tool being developed by Talecris and BBI will enable physicians to test patients' AAT levels in their offices, and obtain results within minutes. Early and proper diagnosis of AAT Deficiency is vital to managing and treating this rare chronic disorder.

"For people with Alpha-1 Antitrypsin Deficiency, early detection is key to slowing disease progression," said John W. Walsh, president, CEO, and co-founder of the Alpha-1 Foundation. "The agreement to develop a new, faster testing tool for screening for AAT represents a significant milestone for the Alpha-1 community and greatly supports the Foundation's goal to identify and improve the lives of persons with AAT Deficiency, a disorder that is so often misdiagnosed."

"We are excited to be developing a method that will enable a greater number of patients to be screened for AAT because it will enable us to improve the care of people with AAT Deficiency," said Bernhard Schaefer, vice president, Pulmonary, Talecris. "This investment is another example of Talecris' commitment to continue our 17 years of leadership by developing and supporting tools and programs to identify people with AAT Deficiency."

Under the terms of the agreement, Talecris and BBI will work to develop a rapid lateral flow tool to screen patients' AAT levels. The tool will help to identify patients who may benefit from treatment with Talecris' therapy, Prolastin®, (Alpha-1 Proteinase Inhibitor (Human)). The phased development program is scheduled for completion by the end of 2006.

"For the pharmaceutical and diagnostic industries to be working together in this way is a really positive move forward for both markets, and this pioneering approach will pave the way for future collaborations like this, not just for BBI and Talecris, but for the industry as a whole," said Julian Baines, CEO of BBI.

In addition to the development of this new screening tool, Talecris also supports the Alpha-1 Foundation's National Targeted Detection Program (www.shortofbreathgettested.org). This targeted-detection program promotes worldwide awareness and the identification of AAT Deficient individuals in population groups at high risk for AAT Deficiency, such as adults with Chronic Obstructive Pulmonary Disease (COPD), chronic asthma and/or chronic liver disease.

About Alpha-1 Antitrypsin Deficiency

Alpha-1 Antitrypsin Deficiency, also known as AAT Deficiency or Alpha-1, is an inherited disorder that causes significant reduction in the naturally occurring protein AAT. It is most common in the Caucasian population of northern Europe and North America. AAT Deficiency is also the most common cause of genetic liver disease in children, and genetic emphysema (shortness of breath) in adults. Individuals suffering from AAT Deficiency often develop severe obstructive pulmonary diseases (COPD) causing disability and premature death. AAT Deficiency affects some 150,000 people in North America and Europe.

About Prolastin®

Prolastin®, (Alpha-1 Proteinase Inhibitor (Human)) is indicated for chronic replacement therapy of individuals having congenital deficiency of Alpha-1 PI with clinically demonstrable panacinar emphysema. Prolastin® is not indicated in for use in patients other than those with PiZZ, PiZ (null) or Pi (null)(null) phenotypes.

Important Safety Information

Weekly Prolastin® therapy has demonstrated a low occurrence of side effects. In clinical studies with Prolastin®, reactions were observed in 1.16% of patients, the most common events being fever (0.77%), lightheadedness (0.19%) and dizziness (0.19%). As with any plasma-derived products, the theoretical risk of virus transmission cannot be ruled out. 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.

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 cutting-edge 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.
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