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Phase III Study of Neutralase in CABG Halted, Drug Development Program Terminated

NOVATO, Calif., Sept. 22 /PRNewswire-FirstCall/ -- BioMarin Pharmaceutical Inc. (NASDAQ:BMRN) announced that it halted its Phase 3a study of Neutralase(TM) for the reversal of anticoagulation by heparin in primary Coronary Artery Bypass Graft (CABG) surgery and that it has terminated its Neutralase program for all indications.

The decision to halt the Phase 3 study resulted from a recommendation from an independent Data Safety Monitoring Board (DSMB) and was based on a review of data from enrolled patients, which indicated with high probability that Neutralase would not demonstrate favorable safety and efficacy. Given the expected risk/benefit profile for Neutralase, BioMarin has decided to stop development of the drug for all indications.

Fredric D. Price, Chairman and Chief Executive Officer of BioMarin stated, "While we are disappointed that Neutralase will not become a successful product, it is better to have learned this relatively early in its development at BioMarin. We have planned BioMarin's product portfolio carefully, and have adequate resources for our other promising product opportunities, including Aryplase(TM), which is in a pivotal Phase 3 trial."

Source: BioMarin Pharmaceutical Inc.

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