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

t an expanded cohort of patients at the maximum tolerated dose.  The company has cleared a safety review after dosing the 5 mg/kg cohort and has authorization to start enrolling patients at 10 mg/kg.  Top-line results are expected in the second half of 2012.
  • BMN-673 (PARP inhibitor):  BioMarin has two ongoing trials for BMN-673.  In the first quarter of 2011, the company initiated a Phase I/II open-label trial of once daily, orally administered BMN-673 for advanced or recurrent solid tumors.  In July 2011, the company initiated a Phase I, two-arm, open-label, dose escalation study for BMN-673 for the treatment of patients with advanced hematological malignancies.  The primary objective of the studies is to establish the maximum tolerated dose of daily oral BMN-673 and to obtain preliminary efficacy data in an expanded cohort of patients with genetically-defined tumors.  

    • Preclinical Programs

  • BMN-111 for Achondroplasia: Regulatory interactions are underway, and 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), a small cyclic peptide that is a positive regulator of bone growth, for achondroplasia, the most common form of dwarfism.  There are approximately 18,000 to 24,000 patients in the U.S. and Europe, an estimated 25 percent of which could be candidates for treatment with a product like BMN-111.
  • Other early stage programs: BioMarin is working on multiple early development opportunities.

    • Non-GAAP Financial Information and ReconciliationThe above results for the three and six months ended June 30, 2011 and June 30, 2010 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, non-GAAP income is based on GAAP Earnings Before Interest, Taxes, Depreciation
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    SOURCE BioMarin Pharmaceutical Inc.
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