Genaera Corporation announced issuance by the United States Patent and Trademark Office of patent number 6,602,850 covering the use of certain soluble human interleukin-9 (IL-9) receptor protein variants as a method for treating bronchial hyperresponsiveness and asthma. Bronchial hyperresponsiveness is the excess reaction of airway narrowing associated with the symptoms of a variety of respiratory illnesses, including asthma.

"This patent is another component of our intellectual property strategy to protect the use of the various therapeutic alternatives that could neutralize IL-9," noted Roy C. Levitt, President and Chief Executive Officer. "It is important to have intellectual property to protect the use of these therapeutic options, even though the current focus is a neutralizing antibody against IL-9. We continue to believe that an antibody or other methods that block the action of IL-9 have the potential to be a breakthrough new therapy for asthma."

Interleukin-9 (IL-9) is implicated in the pathogenesis of asthma and may contribute to other respiratory disorders including chronic obstructive pulmonary disease (COPD) and cystic fibrosis. Biopsies from asthmatic patients have shown an increase in expression of IL-9 as compared to healthy individuals. Published findings, highlighting the central role of IL-9 in asthma, demonstrate its contribution to certain clinical features including bronchial hyperresponsiveness, IgE and mucus overproduction and eosinophil up-regulation in animal models and in patients. Genaera believes that a neutralizing antibody to IL-9 provides a novel approach to prophylaxis or treatment for asthma, and provides an important alternative to the non-specific therapies currently in use.

In April 2001, Genaera entered into a Collaboration and License agreement with MedImmune Inc to co-develop an IL-9 product for asthma. This alliance provided Genaera with a significant upfront payment, guaranteed research and development support through April 2003, future royalties, and up to $55 million in milestone payments. MedImmune will conduct all development, manufacturing, marketing and sales for any product. MedImmune currently anticipates filing an Investigative New Drug (IND) application with the U.S. Food and Drug Administration for the lead anti-IL-9 antibody in the second half of 2003.

According to the National Institute of Allergies and Infectious Disease (NIAID) and the American Lung Association, there are over 65 million patients suffering from diseases that may be IL-9 mediated, including 17 million asthmatics, 35 million respiratory allergy sufferers, 13 million sufferers of chronic bronchitis, and 2.4 million patients afflicted with COPD, a disease which claims the lives of over 107,000 Americans annually. Currently, there is a significant unmet medical need for safe and effective therapies for the respiratory distress caused by many chronic respiratory disorders, including moderate to severe asthma. Many of these disorders currently are treated symptomatically with non-specific anti-inflammatory drugs, antibiotics, or bronchodilators for prophylaxis or rescue use.