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

aluate 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 treat an expanded cohort of patients at the maximum tolerated dose.

Preclinical Programs

  • BMN-111 for Achondroplasia: BioMarin expects to initiate a Phase I trial by the first quarter of 2012.  BMN-111 is an analog of C-type Natriuretic Peptide (CNP) for achondroplasia, a small cyclic peptide that is a positive regulator of bone growth.  Achondroplasia is the most common form of dwarfism.  There are approximately between 18,000 and 24,000 patients in the U.S. and Europe, 25 percent of which is the estimated addressable market.
  • Other early stage programs: BioMarin is working on multiple early development opportunities.

    • Non-GAAP Financial Information and ReconciliationThe above results for the three months and year ended December 31, 2010 and December 31, 2009 and financial guidance for the year ending December 31, 2011 are presented both as determined in accordance with GAAP and on a non-GAAP basis. As used in this release for the three months and year ended December 31, 2010 and December 31, 2009, non-GAAP income is calculated in accordance with GAAP, but excludes non-cash stock compensation expense and certain nonrecurring material items. The financial guidance for the year ending December 31, 2011 is based on Earnings Before Interest, Taxes, Depreciation and Amortization (EBITDA) adjusted to exclude non-cash stock compensation expense, contingent consideration expense and certain nonrecurring materia
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    SOURCE BioMarin Pharmaceutical Inc.
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