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BioMarin Announces Third Quarter 2010 Financial Results
Date:10/28/2010

or LEMS in the U.S. by early 2011.  If successful, NDA submission is expected in the first half of 2012, followed by approval by the end of 2012.
  • GALNS for MPS IVA: BioMarin expects to initiate a 24-week pivotal Phase III study with six-minute walk distance as the primary endpoint early in the first quarter of 2011.
  • Kuvan outcomes study/ Hand-Held Blood Phe Monitor: 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.  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.

  • Mid-Stage Programs

  • PEG-PAL for PKU: The ongoing Phase II clinical trial is an open-label, multi-center study conducted in a series of dose-escalating cohorts.  The primary treatment period of eight weekly injections at a fixed dose is followed by dose and frequency optimization and an extension period.  All 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 fourth quarter of 2011 or the first quarter of 2012.

  • Preclinical Programs

  • BMN-673 (PARP inhibitor):  The company expects to file an IND for BMN-673 by the end of 2010 and initiate a Phase 1b trial in the first quarter of 2011.  BioMarin believes that, based upon internal preclinical experiments, BMN-673 may be ultimately superior to other compounds currently in clinical development.
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