Designation Provides Incentives that Support the Company's Ongoing Aerosol Development ProgramRESEARCH TRIANGLE PARK, N.C., Feb 05, 2010 (BUSINESS WIRE) -- Talecris Biotherapeutics, Inc. (Nasdaq: TLCR) announced today that it
was granted orphan drug designation by the U.S. Food and Drug
Administration (FDA) for the development of an aerosol formulation of
Alpha1-Proteinase Inhibitor (Human, A1PI) to treat congenital
alpha1-antitrypsin (AAT) deficiency. AAT deficiency is a
chronic, hereditary condition that increases the risk of certain
diseases, especially emphysema, which typically emerges in the fourth
decade of life. Currently, there are no approved, inhaled treatments
available for the treatment of AAT deficiency.
Orphan drug designation is granted to companies to encourage the
development of treatments that prevent, diagnose or treat rare,
life-threatening or chronic illnesses that affect fewer than 200,000
people per year in the U.S. The designation provides incentives such as
tax credits and potentially seven years of market exclusivity to
companies willing to support the costly research and development
programs associated with developing specialized drugs for a small
population of individuals.
The initiative helps to give patients suffering from rare diseases
access to the same quality of treatment as other patients. Talecris
received a similar orphan drug designation for the aerosolized form of
AAT from the European Commission in June of 2008.
Talecris is the manufacturer of PROLASTIN(R) (Alpha1-Proteinase
Inhibitor [Human]) an intravenous therapy that is indicated for chronic
augmentation therapy among individuals who have AAT deficiency.
Individuals with AAT deficiency have low serum concentrations of the
A1PI protein in their blood and lungs. Augmentation therapy is
administered to raise levels of the A1PI protein.
"Talecris is committed to helping patients with rare diseases for whom
few treatment options exist," said Lawrence D. Stern, chairman and CEO
of Talecris. "This orphan drug designation will allow us to move forward
with developing an alternative method of delivering augmentation therapy
for patients who prefer an inhaled mode of administration."
An important part of Talecris' aerosol development program is the
exclusive partnership between Talecris and Activaero Technologies (www.activaero.de/en.php),
an industry leader in controlled breathing technologies for inhaled
therapeutic agents. Activaero's AKITA2(R) APIXNEB inhalation
system has demonstrated consistently high drug deposition to the central
and peripheral regions of the lungs in patients with AAT deficiency,
regardless of disease severity.
About PROLASTIN(R)
PROLASTIN (Alpha1-Proteinase Inhibitor [Human]) is
derived from human plasma and is administered intravenously to raise the
levels of A1PI in the blood and lungs. PROLASTIN is indicated for
chronic augmentation and maintenance therapy of individuals having
congenital deficiency of A1PI (alpha1-antitrypsin deficiency)
with clinically demonstrable panacinar emphysema. PROLASTIN was the
first plasma-derived A1PI augmentation therapy to receive approval from
the U.S. Food and Drug Administration (FDA) and was approved in December
1987 and launched in February 1988.
Important Safety Information
PROLASTIN, Alpha1-Proteinase
Inhibitor (Human) is indicated for chronic augmentation and maintenance
therapy of individuals having congenital deficiency of alpha1- PI
(alpha1-antitrypsin deficiency) with clinically demonstrable
panacinar emphysema. Individuals with selective IgA deficiencies who
have known antibody against IgA (anti-IgA antibody) should not receive
PROLASTIN, since these patients may experience severe reactions,
including anaphylaxis, to IgA which may be present. In clinical studies
with PROLASTIN, reactions were observed in 1.16% of infusions, the most
common events being fever, light-headedness and dizziness.
PROLASTIN is made from human plasma. Products made from human plasma may
carry a risk of transmitting infectious agents, e.g., viruses, and
theoretically, the Creutzfeldt-Jakob disease (CJD) agent. There is also
the possibility that unknown infectious agents may be present in such
products.
For additional information on PROLASTIN, please see full prescribing
information at www.PROLASTIN.com.
About Alpha1-Antitrypsin Deficiency
Alpha1-antitrypsin
deficiency, also known as AAT deficiency or Alpha-1, is an inherited
disorder that causes significant reduction in the naturally occurring
protein alpha1-proteinase inhibitor . 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 disease (COPD) causing disability and premature
death. AAT deficiency is estimated to affect 200,000 people in North
America and Europe.
About Talecris Biotherapeutics: Inspiration. Dedication.
Innovation.
Talecris Biotherapeutics (Nasdaq: TLCR) 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, neurology and
hemostasis. (www.talecris.com)
Cautionary statement regarding forward-looking statements
This
press release contains forward-looking statements within the meaning of
the safe harbor provisions of the U.S. Private Securities Litigation
Reform Act of 1995. These statements include, but are not limited to,
quotations from management in this press release, statements regarding
strategic and operation plans, and statements regarding the development
or commercialization of therapies. Forward-looking statements are based
on current beliefs and expectations and are subject to inherent risks
and uncertainties. You are cautioned not to place undue reliance on
forward-looking statements. Although Talecris believes that the
forward-looking statements contained in this press release are
reasonable, there is no assurance that expectations will be fulfilled.
The following factors, among others, could cause actual results to
differ materially from those expressed or implied in forward-looking
statements: possible U.S. legislation or regulatory action affecting,
among other things, the U.S. healthcare system, pharmaceutical pricing
and reimbursement, including Medicaid and Medicare; our ability to
procure adequate quantities of plasma and other materials which are
acceptable for use in our manufacturing processes from our own plasma
collection centers or from third-party vendors; our ability to maintain
compliance with government regulations and licenses, including those
related to plasma collection, production and marketing; our ability to
identify growth opportunities for existing products and our ability to
identify and develop new product candidates through our research and
development activities; and the timing of, and our ability to, obtain
and/or maintain regulatory approvals for new product candidates, the
rate and degree of market acceptance, and the clinical utility of our
products. Additional information about factors that could affect the
business and financial results of Talecris is contained in its final
Prospectus filed pursuant to Rule 424(b)(1) with the Securities and
Exchange Commission on October 1, 2009. Talecris undertakes no duty to
update any forward-looking statement.

SOURCE: Talecris Biotherapeutics, Inc.
Talecris Biotherapeutics, Inc.
Becky Levine. 919-316-6316
Fax: 919-316-6377
becky.levine@talecris.com