Arriva Pharmaceuticals Granted Fusion Protein Patent

Business Wire, May 21, 2008

Intellectual Property Provides Strong Position for Development of Therapy for Asthma

ALAMEDA, Calif. -- Arriva Pharmaceuticals, a biopharmaceutical company focused on developing anti-inflammatory therapies, announced today that it had been granted a patent in the U.S. related to a fusion protein with potential applications for treating respiratory diseases. The patent (United States Patent 7,247,704) covers compositions of matter and uses of Aeriva[TM], a fusion protein that combines Secretory Leukocyte Protease Inhibitor (SLPI) and recombinant alpha 1-antitrypsin (rAAT). A similar patent was recently granted by the European Patent Office and will soon issue in several European countries, including the United Kingdom, France and Germany.

"This is a strong patent in the field of fusion proteins, where there is a proven track record of commercial success," said Sue Preston, chief executive officer of Arriva. "This patent gives Arriva a significant advantage as we move forward with the development of therapies to address the needs of patients with respiratory disease."

The Aeriva[TM] protein, which can be produced in high levels in yeast, inhibits activity in key enzymes that play roles in respiratory disease. The protein affects elastase, an enzyme that breaks down a lung structural protein, leading to emphysema. SLPI also impacts mast cell chymase and tryptase, and thrombin, each of which may be involved in airway remodeling in asthma.

"Aeriva[TM]is a double-barreled protease inhibitor," said Dr. Philip Barr, chief scientific officer of Arriva. "Because of its ability to inhibit the activity of a multiplicity of enzymes, Aeriva[TM] has potential as a treatment across a range of respiratory diseases."

Aeriva[TM] has demonstrated activity in ex vivo studies with smokers with chronic obstructive pulmonary disease (COPD). In addition, the protein has shown to affect airway hyperresponsiveness, a characteristic feature of asthma, in a sensitized sheep model.

Speaking from the American Thoracic Society meeting in Toronto, Dr. Trevor Hansel, MD, medical director of the UK National Heart and Lung Institute's clinical studies unit at Imperial College, London, and a collaborator on studies with Aeriva[TM], said, "I believe that Aeriva[TM] holds real promise as a specific targeted anti-protease therapy that is distinct from current anti-inflammatory treatments. Proteases are fundamental enzymes that exacerbate inflammation, fibrosis and tissue destruction. Aeriva[TM] is a novel approach that targets proteases and is based on modern recombinant DNA-derived protein production technology. Aeriva[TM] offers a rational therapy with potential for the treatment of patients with both severe asthma and COPD."

Aeriva[TM] is part of Arriva's pipeline of compounds focused on respiratory disease. The company is conducting human clinical trials with nebulized rAAT product to treat hereditary emphysema. The company has completed a Phase 1a safety study and a Phase 1b/2a proof-of-concept study. In addition, Arriva is developing inhaled ilomastat, a potent, broad-spectrum inhibitor of matrix metalloproteases that has shown to be active in a number of animal model systems of inflammation.

About Arriva

Arriva Pharmaceuticals is a privately held biopharmaceutical company focused on developing anti-inflammatory therapies for treating respiratory diseases. The company's areas of therapeutic focus are: hereditary emphysema, chronic obstructive pulmonary disease (COPD) including smoking-related emphysema, cystic fibrosis and other respiratory indications. Arriva Pharmaceuticals BV, is headquartered in Amsterdam, the Netherlands, and its majority-owned subsidiary, Arriva Pharmaceuticals, Inc., is located in Alameda, California. For additional information please visit: http://www.arrivapharm.com