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

-701 for Pompe Disease: The Phase I/II trial in Pompe patients is an open-label study to evaluate 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 has completed enrollment of patients in the 10 mg/kg dose cohort.  Top-line results are expected in the second half of 2012.
  • BMN-673 (PARP inhibitor):  BioMarin has two ongoing trials for BMN-673: a Phase I/II open-label trial of once daily, orally administered BMN-673 for advanced or recurrent solid tumors and a Phase I, two-arm, open-label, dose escalation study for BMN-673 for the treatment of patients with advanced hematological malignancies.  Top-line results for both studies are expected in the second half of 2012.

  • Preclinical Programs

  • BMN-111 for Achondroplasia: BioMarin expects to file an IND in the fourth quarter of 2011 and initiate a Phase I trial in 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.  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 additional early development opportunities.

  • Non-GAAP Financial Information and ReconciliationThe above results for the three and nine months ended September 30, 2011 and September 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 and Amortization (EBITDA) adjusted to exclude non-cash stock compensation expense, continge
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    SOURCE BioMarin Pharmaceutical Inc.
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