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BioMarin Announces Second Quarter 2011 Financial Results
Date:7/28/2011

ects to enroll approximately 160 patients across 40 centers worldwide and to report top-line results in the second half of 2012.
  • 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.  The company expects to report top-line results in the second half of 2012.
  • Hand-Held Blood Phe Monitor: Several programs are underway to expand and protect the market and to improve the ability of healthcare providers and patients to better manage PKU.  Regulatory clearance and commercial availability of the handheld blood Phe monitor are expected between the first quarter of 2013 and the third quarter of 2013.
  • Firdapse: BioMarin initiated 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 formulation study and the ongoing daily dosing study are expected in the third or fourth quarter of 2011.  The company expects to initiate a Phase III trial in the first or second quarter of 2012.

  • Early-Stage Clinical Programs

  • 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 trea
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