Active Aerosol Development Program

RESEARCH TRIANGLE PARK, N.C.–(EMWNews)–Talecris Biotherapeutics, Inc. (http://www.talecris.com)

announced today that the European Commission followed an opinion of the

Committee for Orphan Medicinal Products (COMP) and has granted orphan

drug designation to Talecris’ alpha-1

proteinase inhibitor (human) for inhalation use in the treatment of

congenital Alpha₁-Antitrypsin Deficiency

(also known as AAT Deficiency or Alpha-1). Currently, there are no

approved aerosolized treatments available for augmentation therapy for

AAT Deficiency.

By providing incentives to the pharmaceutical industry, the EU

legislative framework for orphan medicines encourages the development of

products intended for the diagnosis, prevention or treatment of

life-threatening or chronically debilitating conditions impacting no

more than 5 in 10,000 people in the European Union. The initiative helps

to give patients suffering from rare diseases access to the same quality

of treatment as other patients.

Through this designation, the European Medicines Agency (EMEA) will

provide to Talecris ten years of market exclusivity if the product is

the first to be approved for marketing in the European Union. In

addition, under this designation, EMEA will provide Talecris with

clinical development assistance and reduced regulatory fees. The Food

and Drug Administration (FDA) has a similar designation for products

developed to treat orphan diseases in the United States. Talecris

intends to seek orphan drug designation in the US.

Larry Stern, chief executive officer of Talecris Biotherapeutics, said, “The

European Commission’s designation provides

another promising development milestone for Talecris in the expansion of

our alpha-1 franchise—a pursuit that reflects

our ongoing commitment to offer clinical advancements that will benefit

patients.”

An important part of this alpha-1 antitrypsin aerosol development

program is the exclusive partnership between Talecris and Activaero

Technologies (http://www.activaero.de/en.php),

an industry leader in controlled breathing technologies for inhaled

therapeutic agents, for its AKITA^2®

APIXNEB inhalation system. This system has demonstrated consistently

high drug deposition to the central and peripheral regions of the lungs

in patients with AAT Deficiency independent of disease severity. For

more information on Talecris Research and Development programs, please

visit http://www.talecris.com.

Talecris Biotherapeutics, Inc.: Inspiration. Dedication.

Innovation.

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, with revenues of approximately $1.2 billion in 2007, is

headquartered in biotech hub Research Triangle Park, N.C., and employs

more than 4,000 talented people worldwide.

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.

About Alpha₁-Antitrypsin

Deficiency

Severe Alpha-1-Antitrypsin Deficiency, also known as AAT Deficiency or

Alpha-1, is an inherited disorder that causes a significant reduction of

the serum concentration of 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. In adults, AAT Deficiency is associated with a

predisposition for severe chronic obstructive pulmonary disease (COPD),

especially early-onset emphysema causing disability and premature death.

An estimated 100,000 people in the United States have AAT Deficiency. In

Europe, the prevalence of AAT Deficiency is about 2.5 in 10,000

individuals.

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