BIOMARIN FILES CTX TO CONDUCT CLINICAL TRIAL OF VIBRIOLYSIN.

BioMarin Pharmaceutical Inc. (Nasdaq and SWX New Market: BMRN) has filed a Clinical Trial Exemption (CTX) application with the Medicines Control Agency (MCA) in the United Kingdom for permission to conduct a human clinical trial of Vibriolysin Topical in patients with serious burns. Vibriolysin Topical has displayed promising efficacy in numerous preclinical studies related to the debridement (cleaning) of dead tissue resulting from serious burns. Pending approval of the CTX by the MCA, the company anticipates initiating a clinical trial of Vibriolysin Topical in the United Kingdom.

Fredric D. Price, chairman and chief executive officer of BioMarin, said, "Vibriolysin Topical will represent BioMarin's third enzyme-based product to be tested in humans. In the second half of 2001, we will unblind data from our first two clinical programs: our Phase III trial of Aldurazyme for the treatment of MPS-I and our Phase I trial of rhASB for the treatment of MPS-VI. Filing the CTX for Vibriolysin Topical further demonstrates the company's commitment to developing novel enzyme therapies for unmet medical needs."

Treatment of an acute burn injury requires the removal of dead tissue to enable healing. Depending on the depth and location of the wound, debridement may be attempted by topical drug treatment or manual methods that have been devised to reduce the blood loss and pain inherent in surgery. According to the American Burn Association, there are approximately 45,000 patients per year with serious burns admitted to hospitals and specialized burn centers in the United States. BioMarin believes there is a significant number of burn patients in other countries in the developed world who could also potentially benefit from a new debridement treatment.

Stuart J. Swiedler, MD, PhD, BioMarin's vice president, Scientific and Clinical Affairs, said, "Vibriolysin Topical's unique propensity for selectively breaking down dead tissue without digesting healthy tissue, as demonstrated in preclinical studies, suggests that Vibriolysin Topical may offer physicians treating burns a safe and effective alternative to surgery and other less effective topical drugs for the debridement of burn wounds."

BioMarin specializes in the development and commercialization of therapeutic enzyme products. Since inception in 1997, BioMarin has applied its proprietary enzyme technology to develop products for lysosomal storage diseases and for the treatment of serious burns. Glyko, Inc., a BioMarin subsidiary, provides analytical and diagnostic products and services in the area of carbohydrate biology.

BioMarin can be found on the World Wide Web at http://www.biomarinpharm.com/vibriolysin.

For more information, call 415/884-6700.