Vancouver, September 7, 1999 - Micrologix Biotech Inc. is pleased to announce that the U.S. Food and Drug Administration (FDA) has granted fast track designation to MBI 226, the Company's antimicrobial drug product for the prevention of central venous catheter-related bloodstream infections.

The fast track process was authorized by the FDA Modernization Act of 1997. It is designed to facilitate the development and expedite the review of new drugs or biologicals that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs.

"We are greatly appreciative of the FDA's decision to grant MBI 226 a more rapid review and their acknowledgement of the importance of our approach to preventing serious bloodstream infections related to intravenous catheterization," said David Friedland, Micrologix's Head of Clinical Development. "This fast track designation will permit us to pursue the fastest possible approval path for MBI 226."

Earlier this year, Micrologix reported results from a US Phase I clinical trial of MBI 226. Safety was assessed in 12 subjects on whom MBI 226 was applied daily for five days at the insertion site of intravenous catheters. MBI 226 was shown to be safe, non-irritating, non-sensitizing and generally well tolerated. The Phase I study also included an assessment of the effectiveness of MBI 226 in preventing the growth (or colonization) of bacteria and fungi on the skin of healthy volunteers and on surfaces of implanted intravenous catheters. A single application of MBI 226 reduced the number of microorganisms on the skin surface of the subjects by more than 99.9% compared to the placebo control. Additionally, it was observed that 83% of the subjects in the placebo control group (five of six subjects) showed colonization of their intravenous catheters, whereas no colonization was detected on the catheters removed from all six subjects treated with MBI 226. These results are considered significant as skin colonization and catheter colonization are the two antecedent steps that can ultimately lead to invasive bacterial and fungal disease, particularly bloodstream infection.

The Centers for Disease Control and Prevention in Atlanta estimate that in the US alone, 200,000 hospital patients contract device-related bloodstream infections each year. Central venous catheters cause more than 90% of these infections, and on average, infected patients spend an additional 6.5 days in intensive care at a cost of US$29,000 per patient. The associated mortality rate is high: up to 50,000 patients die annually from these bloodstream infections. More effective means of prevention or treatment would save many lives and billions of dollars in health care costs in North America alone.

Micrologix has been working with the FDA on the design of the MBI 226 Phase II clinical trial anticipated to commence this fall. As a result of being granted fast track designation for MBI 226, Micrologix has initiated concurrent discussions with the FDA on the design of the Phase III clinical trial.

Micrologix Biotech Inc. is a biopharmaceutical company developing novel drugs to treat severe and life-threatening diseases-particularly those caused by antibiotic-resistant microorganisms. The Company has a broad portfolio of drug candidates based on improved analogs of the anti-infective peptide compounds found in the host-defense systems of most life forms. Micrologix has completed Phase I and plans to initiate a Phase II clinical trial later this year for the prevention of catheter-related bloodstream infections. In addition, the Company has preclinical development programs for severe inflammatory acne, eye infections and other serious diseases.