Vancouver, CANADA, September 20, 2000 - Micrologix Biotech Inc. announced today the initiation of Phase III clinical trials in the United States for MBI 226, its novel lead antimicrobial drug product. The trials are designed to demonstrate whether the drug reduces the incidence of life-threatening bacterial and fungal bloodstream infections related to the use of central venous catheters (CVCs) in seriously ill patients. The results of the Phase III studies will be used in support of a New Drug Application for marketing approval of MBI 226 in the US.

"We are extremely pleased to begin these pivotal Phase III trials of MBI 226, the first of a number of drug candidates to come out of Micrologix's research and development programs," said Dany Hadary, President and CEO of Micrologix Biotech Inc. "Achieving this important milestone on schedule and just 21 months after starting Phase I is a significant accomplishment. We will continue to aggressively pursue the commercialization of what will potentially be the first FDA-approved drug to prevent these life-threatening bloodstream infections".

Micrologix previously reported that the FDA granted MBI 226 fast track status following positive findings from a Phase I study, which demonstrated the drug to be safe and effective in completely eliminating bacterial colonization of indwelling peripheral catheters. Micrologix subsequently completed a Phase II safety study confirming in 238 participants that MBI 226 is safe and well tolerated.

The objective of the Phase III trials is to demonstrate that MBI 226, administered at central venous catheter insertion sites, reduces or eliminates bacterial and fungal colonization of the catheters and prevents subsequent bloodstream infections. In the Phase III trials, MBI 226 will be compared to the current standard-of-care, in randomized, blinded, multicenter studies.

Micrologix has initiated patient recruitment in the first of two pivotal Phase III studies. The first study, which is anticipated to be complete in 12 months, will enroll approximately 1500 patients at 12 sites throughout the United States. Preparations are underway to begin the second pivotal study, with the entire Phase III program expected to be complete in 18 months. Each of these two Phase III trials will be amongst the largest prospective studies ever performed to examine bloodstream infections related to central venous catheters.

Dr. Dennis Maki, Professor of Medicine and Head of Infectious Disease at the University of Wisconsin Medical School and Chair of Micrologix's Clinical Advisory Board, said, "CVC-related bloodstream infection is a major medical concern and one that continues to grow as more and more of these devices are placed in patients each year. There is an urgent need for an FDA-approved antimicrobial agent that can prevent these infections and thereby reduce the related high rates of morbidity and mortality." Dr. Maki is an acknowledged world expert in the pathogenesis and prevention of infections related to the use of medical devices.

Background on CVC-Related Bloodstream Infections and Previous Clinical Trial Results

CVCs are devices used by physicians to deliver therapeutic and nutritional agents, sample blood and monitor a patient's status. They are commonly inserted through the chest wall into a major vein, such as the jugular vein. Each year in the US, more than five million CVCs are sold, and it is estimated that catheter-related bloodstream infections develop in 250,000 to 400,000 patients, resulting in at least 50,000 deaths. On average, a patient with a CVC-related bloodstream infection spends an additional 6.5 days in intensive care at a cost of US$29,000. As such, these infections increase the annual cost to the US health care system by more than US$7 billion annually.

The vast majority of CVC-related bloodstream infections occur when bacteria and/or fungi that colonize the patient's skin around the catheter insertion site migrate down the catheter tract to colonize the implanted portion of the device. These microorganisms then break away from the colonized catheter, seeding into the blood and causing subsequent bloodstream infections, also known as "blood poisoning". In many cases, the organisms that cause these infections have developed resistance to conventional antibiotics. In Phase I clinical trials, Micrologix demonstrated that MBI 226 reduced the number of microorganisms growing on the skin of healthy subjects by 99.9% and the incidence of catheter colonization to zero. In Phase II clinical trials, MBI 226 was non-irritating, did not cause an allergic immune response and was not absorbed into the bloodstream.

CORPORATE PROFILE

Micrologix Biotech Inc. develops novel drugs targeted at severe and life-threatening diseases-particularly those caused by antibiotic-resistant bacteria. The Company's portfolio of antibiotic drug candidates is based on improved analogs of naturally occurring cationic peptides found in the host defense systems of most life forms. Micrologix currently has three drugs in clinical trials in the US ¾ MBI 226 for the prevention of catheter-related bloodstream infections, MBI 594AN for the treatment of acne and MBI 853NL for the prevention of hospital-acquired Staphylococcus aureus infections. Micrologix recently completed Phase I clinical trials of MBI 594AN and MBI 853NL and anticipates initiating further clinical trials for these drug candidates during the fourth quarter of 2000.

CONFERENCE CALL

Investors, analysts and the media are invited to participate in a conference call today at 11:00 a.m. EST to discuss this announcement. Please telephone 1-800-387-2195 (US and Canada) or (416) 641-6663 (Toronto-area callers).