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BAXTER
AND ARRIVA PHARMACEUTICALS BEGIN CLINICAL TRIALS FOR RECOMBINANT ALPHA
1-ANTITRYPSIN
DEERFIELD, Ill. and
ALAMEDA, Calif., March 4, 2003 -- Baxter Healthcare Corporation (Baxter)
and its partner Arriva Pharmaceuticals, Inc. (Arriva) announced today
the commencement of Phase I clinical trials in patients suffering from
Alpha-1 Antitrypsin Deficiency, also known as hereditary emphysema. These
clinical trials, being conducted in the United States, will evaluate the
safety, immunogenicity, and tolerability of the jointly developed recombinant
alpha 1-antitrypsin (AAT) therapy.
The companies' recombinant AAT is the first AAT product in clinical trials
that is produced without the addition of human or animal-derived raw materials
in the fermentation process, purification or final formulation. This recombinant
AAT also has been developed to be delivered to the lungs of patients using
a nebulizer. Current treatment for this condition involves intravenous
infusion of plasma-derived alpha 1-antitrypsin, which is in limited supply,
and cannot meet the current demand in the United States and Europe. While
the plasma-derived treatment is effective, large doses are required to
get therapeutic amounts of the protein to the lung where it is most needed.
"We are very pleased to be making progress in providing an advanced
treatment for patients suffering from hereditary emphysema," said
Martin J. Preuveneers, Ph.D., chairman and chief executive officer of
Arriva. "We are delighted to be partnering with Baxter on this important
trial."
Hereditary emphysema (HE) is a serious hereditary disorder characterized
by low levels of the natural protease inhibitor AAT. Up to 100,000 individuals
in the United States are affected by this disorder that, in certain cases,
leads to excessive inflammation, progressive emphysema, and premature
death if left untreated. The only drug treatment currently available for
individuals with HE involves weekly infusion of a plasma-derived AAT that
has been limited in supply. To address this gap in product supply in the
meantime, Baxter announced in December an agreement with Alpha Therapeutic
Corporation to acquire its plasma-derived AAT, Aralast, which was recently
approved by the FDA. Until the acquisition is finalized, Baxter will serve
as the exclusive, worldwide distributor of Aralast, and will be responsible
for its launch.
Baxter's BioScience business develops and produces biopharmaceuticals
from plasma and through recombinant methods to treat hemophilia, immune
deficiencies and other blood-related disorders, as well as vaccines and
biosurgery products.
Baxter Healthcare Corporation is the principal U.S. operating subsidiary
of Baxter International Inc. (NYSE: BAX). Baxter assists health-care professionals
and their patients with treatment of complex medical conditions, including
cancer, hemophilia, immune disorders, kidney disease and trauma. The company
applies its expertise in medical devices, pharmaceuticals and biotechnology
to make a meaningful difference in patients' lives. For more information
about Baxter, please visit www.baxter.com.
Arriva Pharmaceuticals, Inc., is a privately held biopharmaceutical company.
The company's goals are to develop, manufacture and market clinical grade
recombinant protease inhibitors. Arriva Pharmaceuticals, Inc. has developed
technology for large-scale production of stable non-animal sourced recombinant
proteins in Saccharomyces cerevisiae (Baker's yeast). The company's
areas of therapeutic focus are:
- Respiratory diseases:
HE, asthma, cystic fibrosis, chronic obstructive pulmonary disease (COPD),
and other respiratory indications
- Dermatological
diseases: atopic dermatitis, psoriasis
For more information
about Arriva Pharmaceuticals, Inc., visit the company's Website www.arrivapharm.com.
This news release
contains forward-looking statements that involve risks and uncertainties,
including the timing and results of clinical trials and other development
activities, actions by regulatory authorities at any stage of the development
and commercialization process, economic conditions, market demand, the
impact of competitive products and pricing, technological advances in
the medical field and other risks detailed in the companies' filings with
the Securities and Exchange Commission. These forward-looking statements
are based on estimates and assumptions made by management of the companies
and are believed to be reasonable, though are inherently uncertain and
difficult to predict. Actual results or experience could differ materially
from the forward-looking statements.
FOR ADDITIONAL
INFORMATION:
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Media Contacts:
Deborah Spak, Baxter, 847-948-2349
Tali Kaplan, Baxter, 805-372-3540
Martin J. Preuveneers, Ph.D., Chairman & CEO, Arriva,
510-337-2846, mpreuveneers@arrivapharm.com
Investor Contacts:
- Neville Jeharajah,
Baxter, 847-948-2875
Mary Kay Ladone, Baxter, 847-948-3371
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