October 15, 2004

Aerovance announces data presentations at 18th Annual
North American Cystic Fibrosis Conference. Data provide
strong rationale for entry of AER 002 into clinic in first half of 2005

St. Louis, Mo., Oct. 15, 2004 – Aerovance, Inc. announced today that researchers presented preclinical data today at the 18th Annual North American Cystic Fibrosis (CF) Conference that provide strong support for moving the Company’s second lead product, AER-002 (also known as SPINT2 and Bikunin), into the clinic.

“These studies demonstrate AER-002 could prove to be a potent new therapy for CF patients,” said Rick Fuller, M.D., Chief Medical Officer of Aerovance. “AER 002 could address significant medical issues for CF patients and we are excited to continue our preclinical development work with this product candidate with the goal of entering the clinic in the first half of next year.”

The two posters demonstrated the potential clinical benefits that AER 002 may provide to CF patients such as regulation of salt levels believed to be important in the improvement of mucus clearance and inhibition of certain inflammation-associated destructive enzymes common to CF patients.

“This dual functionality gives this product the potential to be a unique and promising new therapy for CF patients. Importantly, AER 002 appears to act early in the CF disease cascade since abnormal regulation of salt and water transport are seen very early in the disease followed soon thereafter by destructive changes in lung tissue resulting from chronic inflammation,” added Dr. Fuller.

The first poster, “Effects of the Serine Protease Inhibitor, Bikunin (SPINT2), on Nasal Epithelium Potential Difference in Cynomolgus Monkeys: A Novel Treatment for CF,” demonstrated that AER 002 could control how salt is regulated in the lung —an important function in managing CF.

The second poster, “SPINT2 Inhibits Elastase Activity in Bronchoalveolar Lavage Fluids from CF Patients,” showed that AER 002 can inhibit destructive enzymes, found at high levels in CF patients, that can lead to degradation of lung tissue. In addition, the compound appeared to retain its anti-inflammatory properties even when mixed with airway fluid samples from CF patients.

More About AER 002
AER-002, also known as Bikunin and SPINT2, is a protein serine protease inhibitor that improves tracheal mucus velocity and mucus clearance in experimental animal models. These effects are thought to be a consequence of its ability to decrease Na+ (salt) influx in CF airway epithelial cells in vitro and regulate water balance in the airways. In addition to its effect on salt transport, AER 002 affects the activity of other proteins that might be found in inflamed lungs, an observation that triggered Aerovance scientists to assess the molecule’s effects in cellular models of inflammation including its ability to block the activity of inflammatory enzymes, such as neutrophil elastase. AER 002 is in development for treatment of CF and COPD.

About Cystic Fibrosis
Cystic fibrosis is a life-threatening, inherited disease that affects around 70,000 people worldwide. The average life expectancy of a CF patient is 31 years. The current market for all CF therapies is approximately $800 million. Also, about 1 in every 20 Americans is an unaffected carrier of an abnormal "CF gene." These 12 million people are usually unaware that they are carriers.

About Aerovance, Inc
Aerovance is a privately held biopharmaceutical company focused exclusively on the development and commercialization of biologics for severe respiratory and inflammatory diseases such as asthma, cystic fibrosis (CF) and chronic obstructive pulmonary disease (COPD). The company’s two lead products are an IL4/13 receptor antagonist (AER 001) for severe asthma entering Phase II studies and SPINT2 (AER 002), a recombinant protein for CF and COPD on track for the filing of an IND in 2005. In addition to these lead product programs, Aerovance has several preclinical programs in respiratory disease. Aerovance was spun off from Bayer Pharmaceuticals’ biotechnology unit in August 2004. Investors include Apax Partners, Lehman Brothers, NGN Capital and Burrill & Co.

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