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BioMarin Announces Fourth Quarter and Full Year 2010 Financial Results
Date:2/17/2011

The company expects to enroll approximately 160 patients across 40 centers worldwide.
  • Kuvan Outcomes Study: PKU-016, a randomized, placebo-controlled, 13-week Kuvan outcomes study is ongoing.  Endpoints include clinically validated measures of neuropsychiatric symptoms and if successful, may enable a label amendment.  
  • Hand-Held Blood Phe Monitor: Several other programs are underway to expand and protect the market and to improve the ability of healthcare providers and patients to better manage PKU.  These programs include a state-of-the-art handheld device to measure blood Phe levels in PKU patients. Regulatory approval and commercial availability of the handheld blood Phe monitor are expected in late 2011.
  • Firdapse: BioMarin expects to initiate a Phase III trial for LEMS in the U.S. in the second quarter of 2011.  If successful, NDA submission is expected in the first half of 2012, followed by approval by the end of 2012.

  • 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 mid-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 January 2011.  The trial is an open-label study of once daily, orally administered BMN-673 in up to 70 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 January 2011.  The trial is an open-label study to ev
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