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BioMarin Announces Third Quarter 2011 Financial Results
Date:10/27/2011

: Initiation of Phase II trial for BMN-111 for Achondroplasia
4Q 2013: Anticipated regulatory approval of GALNS for MPS IVA

Research and Development ProgramsBioMarin continues to make significant investments in research and development to ensure persistent growth for the company.  The current pipeline includes programs in various stages of development that are focused on treating a range of serious unmet medical needs.  BioMarin will host an R&D Day on Thursday, December 8th in New York to discuss its clinical and preclinical pipeline in detail.Advanced Clinical Programs

  • GALNS for MPS IVA: BioMarin is enrolling patients in a randomized, double-blind, placebo-controlled Phase III study with primary endpoint of six-minute walk distance.  The study will be 24 weeks in treatment duration with treatment doses of two mg/kg/week and two mg/kg/every other week.  The company expects to enroll approximately 160 patients across 40 centers worldwide and is on track 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.
  • Firdapse: The Phase III trial for LEMS for FDA approval in the U.S. is ongoing.

  • Mid-Stage Clinical Programs

  • PEG-PAL for PKU: The company will provide an update on the Phase II study at the R&D Day in December.  The company expects to initiate a Phase III trial in the second half of 2012.
  • Hand-Held Blood Phe Monitor: Regulatory clearance and commercial availability of the handheld blood Phe monitor are expected in the second half of 2013.

  • Early-Stage Clinical Programs

  • BMN
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