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BioMarin Announces First Quarter 2011 Financial Results
Date:4/28/2011

ty of healthcare providers and patients to better manage PKU.  Regulatory approval and commercial availability of the handheld blood Phe monitor are expected in the first half of 2012.
  • Firdapse: BioMarin expects to initiate a Phase III trial for LEMS in the U.S. in the second quarter of 2011.  

  • Mid-Stage Clinical Programs

  • PEG-PAL for PKU: Top-line results for the Phase II study, including a study comparing daily and weekly dosing and a formulation study are expected in the third quarter of 2011.  The company expects to initiate a Phase III trial in the first quarter of 2012.

  • Early-Stage Clinical Programs

  • BMN-673 (PARP inhibitor):  The company initiated a Phase I/II trial in the first quarter of 2011.  The trial is an open-label study of once daily, orally administered BMN-673 in patients ages 18 and older with advanced or recurrent solid tumors.  The primary objective of the study is to establish the maximum tolerated dose of daily oral BMN-673 and to obtain preliminary efficacy data in an expanded cohort of patients with genetically-defined tumors.
  • BMN-701 for Pompe Disease: BioMarin initiated a Phase I/II trial in Pompe patients in the first quarter of 2011.  The trial is an open-label study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamic and clinical activity of BMN-701 administered as an intravenous infusion every two weeks at doses of 5 mg/kg, 10 mg/kg and 20 mg/kg.  The company expects to enroll up to 30 patients between the ages of 13 and 65 years old with late-onset Pompe disease for a treatment period of 24 weeks.  The primary objective of the study is to establish the maximum tolerated dose of every other week administration of BMN-701 and to treat an expanded cohort of patients at the maximum tolerated dose.  Top-line results are expected in the second half of 2012.

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    SOURCE BioMarin Pharmaceutical Inc.
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