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ALPHA
THERAPEUTIC CORPORATION RECEIVES FDA APPROVAL
FOR ARALAST (TM) ALPHA-1 PROTEINASE INHIBITOR
Baxter to serve
as exclusive, worldwide distributor
Los Angeles, Calif.
and Deerfield, Ill. - January 9, 2003 - Alpha Therapeutic Corporation
(Alpha) and Baxter Healthcare Corporation (Baxter) today announced that
Alpha has received U.S. Food and Drug Administration (FDA) authorization
for Aralast (TM) alpha-1 proteinase inhibitor (human)
as augmentation therapy for patients with congenital deficiency of alpha-1
proteinase inhibitor and clinically evident emphysema. Baxter has been
appointed as the exclusive distributor of Aralast (TM)
and will launch the product on behalf of Alpha.
"As a company
dedicated to meeting the needs of people with chronic, life-threatening
diseases, we are pleased to have successfully brought this product from
the clinic and through the approval process," said Edward Colton,
president and CEO of Alpha. "We're very pleased to be working closely
with Baxter to address the needs of an underserved patient population."
Alpha-1 proteinase
inhibitor deficiency (sometimes called alpha-1 antitrypsin deficiency)
results in a form of hereditary emphysema. People with this deficiency
have reduced serum levels of A1PI, an important blood protein manufactured
in the liver. This protein helps protect lung tissue from damage caused
by enzymes that are released by white blood cells. Without sufficient
quantities of A1PI, patients develop lung damage. Symptoms of lung disease
often appear when affected individuals are in their 30s or 40s.
"Less than 10
percent of the estimated 100,000 Americans with A1PI deficiency are accurately
diagnosed and even fewer are receiving augmentation therapy," said
Edward J. Campbell, M.D., professor of medicine, University of Utah. "The
availability of Aralast will allow more patients to be treated."
If left untreated,
A1PI deficiency can result in emphysema and premature death. It is often
misdiagnosed as asthma or Chronic Obstructive Pulmonary Disease (COPD).
The World Health Organization (WHO) recommends that all individuals with
COPD and asthma be tested for the deficiency with a simple blood test.
A1PI deficiency is
treated by augmentation therapy, the weekly infusion of plasma-derived
alpha-1 proteinase inhibitor. Augmentation therapy is not a cure nor will
it reverse lung damage that has already occurred. However, it does protect
the lungs from further damage, making early diagnosis and treatment desirable.
It is important to note that this therapy is not effective in patients
with traditional emphysema and is only indicated for those patients with
emphysema resulting from the congenital deficiency of alpha-1.
Patients and physicians
who want information about obtaining Aralastä should contact Baxter
at (800) 423-2090.
On December 20, 2002,
Alpha entered into a definitive agreement with Baxter Healthcare Corporation
in which Baxter will acquire all rights to Aralast (TM).
This transaction is expected to close in the first half of 2003.
Alpha Therapeutic
Corporation is a leading developer of plasma derived biopharmaceutical
products. Alpha's product portfolio includes coagulation factors, immune
globulin and albumin, which are distributed domestically to hospitals,
pharmacies, home care companies and physicians. Internationally, Alpha's
products are marketed through a network of subsidiaries, affiliates and
local offices in Asia, Europe and Latin America.
Alpha is committed
to providing high quality, safe and cost effective therapeutics for improved
patient care worldwide. Additional company information is available at
www.alphather.com.
Baxter Healthcare
Corporation is the principal domestic operating subsidiary of Baxter International
Inc., (NYSE: BAX), a global health care company that, through its subsidiaries,
provides critical therapies for people with life-threatening conditions.
Baxter's bioscience, medication delivery and renal products and services
are used to treat patients with some of the most challenging medical conditions,
including cancer, hemophilia, immune deficiencies, infectious diseases,
kidney disease and trauma. Baxter BioScience 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. Additional company information is available at www.baxter.com.
This news release contains forward-looking statements that involve
risks and uncertainties, including economic conditions, actions of regulatory
bodies, market demand, the impact of competitive products and pricing,
technological advances in the medical field, foreign exchange and other
risks detailed in Baxter's filings with the Securities and Exchange Commission.
These forward-looking statements are based on estimates and assumptions
made by management of the company 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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- Alpha:
Gary Mull,
(323) 227-7621
Baxter:
- Media Contacts:
- Deborah Spak,
847-948-2349
Tali Kaplan, 805-372-3540
- Investor Contacts:
- Neville Jeharajah,
Baxter, 847-948-2875
Mary Kay Ladone, Baxter, 847-948-3371
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