DEERFIELD, Ill. and ALAMEDA, Calif., February 27, 2004 - Baxter Healthcare Corporation and its development partner, Arriva Pharmaceuticals, Inc., announced today the successful completion of a Phase I clinical trial for a recombinant human alpha 1 -antitrypsin (recombinant AAT or rAAT) molecule administered by nebulization. Recombinant AAT is currently under investigation for an inherited form of emphysema caused by Alpha 1-Antitrypsin Deficiency, also known as hereditary emphysema. The Phase I clinical trial was conducted at four centers in the United States , and evaluated the safety, immunogenicity, and tolerability of the jointly developed rAAT therapy. Results of the trial show that all doses were well tolerated including the maximum amount administered.

 

"We are very pleased to be making progress in investigating this treatment for patients suffering from hereditary emphysema," said Martin J. Preuveneers, Ph.D., chairman and chief executive officer of Arriva. "Results of our Phase I study showed that nebulized recombinant AAT was well tolerated in patients with hereditary emphysema. The successful completion of this first clinical study is an essential step toward moving forward into further clinical trials."

 

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 is being developed in a formulation that allows for delivery to the lungs using a nebulizer. Current treatment for this condition involves intravenous infusion of plasma-derived alpha 1-antitrypsin. While the plasma-derived treatment has been shown to be effective, large doses are required to get therapeutic amounts of the protein to the lung where it is most needed. Clinical trials for recombinant AAT are ongoing.

 

Hereditary emphysema (HE) is a serious hereditary disorder characterized by low levels of the natural protease inhibitor AAT. An estimated 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 currently available treatment option for individuals with HE involves a weekly infusion of plasma-derived AAT.

 

"Baxter is committed to bringing to market new therapies to address hereditary emphysema, where options have been limited," said Ron Lloyd, vice president of Global Marketing in Baxter´s BioScience business. "We recently launched Aralast, which is a plasma-derived AAT, to help address some of the needs in the marketplace. We recognize the potential for a recombinant AAT therapy."

 

Baxter´s BioScience business develops and produces biopharmaceuticals from plasma and through recombinant methods to treat hemophilia, immune disorders 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.