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

$43 to $55Anticipated Upcoming Milestones2Q 2011: Initiation of pivotal Phase III trial for Firdapse for LEMS in the U.S.
3Q 2011: Top-line results from Phase II trial for PEG-PAL, including daily dosing and formulation studies
1Q 2012: Initiation of Phase III trial for PEG-PAL
1Q 2012: Initiation of Phase I trial for BMN-111 for Achondroplasia
1H 2012: 510k approval and commercial availability of the handheld blood Phe monitor for PKU
2H 2012: Top-line results for Phase III trial for GALNS for MPS IVA
2H 2012: Top-line results for PKU-016 Kuvan neurocognitive study
2H 2012: Top-line results for Phase I/II trial for BMN-701 for Pompe disease
4Q 2012/1Q 2013: Market authorization application filings for GALNS for MPS IVA

Research and Development ProgramsBioMarin continues to make significant investments in research and development to ensure persistent growth of the company.  The current pipeline includes programs in various stages of development that are focused on treating a range of serious unmet medical needs.Advanced Clinical Programs

  • GALNS for MPS IVA: BioMarin is enrolling patients in the randomized, double-blind, placebo-controlled Phase III study with primary endpoint of six-minute walk distance, 24 weeks in treatment duration and 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 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 abili
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