Contacts: Joshua A. Grass Susan Ferris Manager, Investor Relations Manager, Corporate Communications BioMarin Pharmaceutical Inc. BioMarin Pharmaceutical Inc. (415) 506-6777 (415) 506-6701
For Immediate Release:
BioMarin Halts Phase 3a Study of Neutralase in CABG and
Terminates the Neutralase Drug Development Program
BioMarin Spending Projected to Decrease in Both 2003 and 2004
Conference Call at 9:00 AM ET (15:00 CET)
Novato, CA, September 22, 2003 - BioMarin Pharmaceutical Inc. (Nasdaq and SWX: BMRN) announced that it halted its Phase 3a study of NeutralaseTM 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.
As a result of the planned reductions in spending related to the discontinuation of Neutralase development, BioMarin has lowered its projected net loss by $5 million for 2003 and by $13 million for 2004. Revised estimates for both net loss and cash burn for 2003 and 2004 are included below, as are previous forecasts for purposes of comparability:
Changes to 2003 and 2004 Forecast ($ in millions)
2003 2004
---- ----
Forecast Current Previous Current Previous
Net Loss $76-$78 $81-$83 $68-$70 $81-$83 Cash Burn $74-$78 $80-$84 $69-$73 $80-$84
As of June 30, 2003, BioMari ...
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