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FDA Approves Aralast Alpha-1 Proteinase Inhibitor Augmentation Treatment For Congenital Deficiency, Emphsysema

LOS ANGELES, CA and DEERFIELD, IL -- 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™ 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 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 Aralast 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. 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 http://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 http://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.


SOURCE: Alpha Therapeutic Corporation; Baxter Healthcare Corporation

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