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Aerovance Announces Positive Top-Line Results from

Phase 2a Trial of Inhaled AEROVANT™ in Asthma Patients

Drug Candidate Reduces Severity of Asthma Attacks

by 72 Percent Compared to Baseline

BERKELEY , Calif. , Jan. 3, 2007 – Aerovance, Inc. today announced positive top-line results from a Phase 2a trial of inhaled AEROVANT™ in asthma patients.

The 30-patient antigen challenge study met its primary endpoint of reducing the severity of late asthmatic response by a statistically significant 72 percent (p<0.001) compared to baseline following the twice-daily use of inhaled AEROVANT™ (IL-4 and IL-13 antagonist) for 27 days. The study also met the secondary endpoint of decreasing the forced expiratory nitric oxide in patients, indicating a reduction in airway inflammation. Aerovance plans to present the full study results at a scientific conference later this year.

“These are very promising data that show the clear-cut effects of inhaled AEROVANT ™ in asthma patients,” said Rick Fuller, M.D., Ph.D., Aerovance’s executive vice president and chief operating officer. “Through the inhibition of the IL-4 and IL-13 receptors, AEROVANT ™ targets the mechanism that is one of the root causes of asthma and other atopic diseases. We plan to initiate a Phase 2b study with a dry powder inhalation formulation in uncontrolled asthma patients later this year.”

Mark Perry, Aerovance’s executive chairman, added: “We are pleased with the results of this study and look forward to advancing our development of AEROVANT ™ . Based on these data, we are initiating strategic partnership discussions for this product.”

Aerovance Announces Positive Top-Line Results

Conducted in London, the Phase 2a trial was a randomized, double-blind, parallel-group, placebo-controlled study designed to assess the safety and efficacy of a 28-day treatment course of inhaled AEROVANT ™ . Thirty patients with mild to moderate asthma were randomized to receive 60 mg of nebulized AEROVANT ™ or volume-matched placebo administered twice daily.

AEROVANT™ is a recombinant human IL-4 variant that is a potent inhibitor of both the IL-4 and IL-13 receptors. Aerovance acquired the worldwide rights to the drug candidate when the company was formed as a spin-out of Bayer Pharmaceuticals Corp. in 2004.

Aerovance, Inc. is a Berkeley, Calif.-based biopharmaceutical company focused on the development and commercialization of breakthrough therapies for the treatment of respiratory and inflammatory diseases. For more information, visit www.aerovance.com.

Editor’s note: Aerovance will present at 10:30 a.m. PST on Jan. 8, 2007 at the JPMorgan Healthcare Conference.

Media Contact:
Tracey Milani
Russo Partners, LLC
(619) 814-3511
tracey.milani@russopartnersllc.com

 

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