Biotech Values

[DewDiligence]

GTCB, Talecris
Talecris Biotherapeutics Announces Start of Licensing Clinical Trials for Alpha-1 Antitrypsin Using Modified Manufacturing Process

[Because GTCB hopes eventually to commercialize a recombinant AAT from transgenic goats for hereditary AAT deficiency, the progress of Talecris’ program using plasma-derived AAT bears watching.

The enhancements mentioned in this PR will make plasma-derived AAT safer than it has been, but a plasma-derived AAT will still not be as safe as a highly purified recombinant product. Talecris is the company that bought Bayer’s plasma-protein business in April, 2005 (#msg-5925270).]

http://biz.yahoo.com/bw/060628/20060628005062.html?.v=1

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Clinical trials to assess pharmacokinetic and safety profile compared to Prolastin(R)

RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--June 28, 2006--Talecris Biotherapeutics has initiated clinical trials with an alpha-1 antitrypsin (AAT) augmentation therapy produced by a manufacturing process that incorporates major technology changes into the current Prolastin® (Alpha-1-Proteinase Inhibitor (Human)) process. The clinical trials follow successful filing of an Investigational New Drug Application (IND) with the United States Food and Drug Administration (FDA) and will compare the AAT produced by the modified process to currently available Prolastin®. Because the manufacturing process for the AAT being studied utilizes major technology changes, Talecris will perform clinical trials to confirm that the pharmacokinetic and safety profiles are comparable to those for Prolastin® in people with alpha-1 antitrypsin deficiency (Alpha-1), a form of genetic emphysema.

The new manufacturing technologies represent ongoing significant investments by Talecris Biotherapeutics. These technologies are more efficient processes that better utilize finite plasma sources and further enhance supply. The new process also includes additional viral inactivation/removal steps, such as nanofiltration, for an even greater margin of pathogen safety. Moreover, these production process improvements create additional opportunities for Talecris to investigate more convenient AAT administration, including novel modes of AAT delivery, such as an aerosol formulation.

"Over the past 20 years, we have worked extremely hard to demonstrate our continuous commitment to the Alpha-1 community," said Alberto Martinez, M.D., President and CEO, Talecris Biotherapeutics. "Our solid history of manufacturing excellence has resulted in a tripling of Prolastin® production since its initial availability. Additionally, our industry-leading scientists and engineers continue to research and apply technologies and processes to optimize available plasma supplies and provide greater availability of Prolastin® to meet the demands of the Alpha-1 community."

Prolastin® initially was approved for patient use nearly two decades ago. For the first 15 years following its initial approval, Prolastin® was the only available AAT augmentation therapy. With these clinical trials, Talecris is continuing its unprecedented commitment to advance standards of care for the Alpha-1 community. As a recognized leader in providing AAT augmentation therapy, Talecris sponsors numerous patient and professional programs and services to increase disease awareness, advance the body of scientific knowledge in Alpha-1, and support product access and adequate reimbursement for patients.

For more information on the clinical trials, visit www.clinicaltrials.gov, using "AAT deficiency" as the search term.

About Prolastin®

Prolastin® is indicated for chronic replacement 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.

Important Safety Information

In clinical studies with Prolastin®, reactions (none severe) were observed in 1.16% of infusions, the most common events being fever, lightheadedness and dizziness. As with all plasma-derived therapeutics, the potential to transmit infectious agents cannot be totally eliminated. For additional information on Prolastin®, please see full prescribing information at www.prolastin.com.

About Alpha-1

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 Talecris Biotherapeutics

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 of approximately $1 billion in 2005, is headquartered in biotech hub Research Triangle Park, N.C., and employs more than 1,800 talented people. To learn more about Talecris and how our employees are making a difference in the lives of patients and the healthcare community, visit www.talecris.com
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