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Halozyme Reports First Quarter 2012 Financial Results
Date:5/7/2012

SAN DIEGO, May 7, 2012 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) today reported financial results for the quarter ended March 31, 2012.

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"We achieved a significant milestone in the first quarter with the European regulatory filing of the subcutaneous Herceptin program by our partner Roche," said Gregory I. Frost, Ph.D., President and Chief Executive Officer, Halozyme. "Despite the HyQ regulatory delay from our Baxter collaboration, our pipeline has continued to make tangible progress on all fronts, as well as across diverse therapeutic areas and geographies."

First Quarter Highlights Highlights of Halozyme's first quarter activities and recent events include:

  • Notification from the European Patent Office (EPO) that a hearing scheduled in opposition of the European patent for Halozyme's recombinant human hyaluronidase enzyme (rHuPH20) was cancelled and the EPO acknowledged the patentability of the claims. The Company anticipates the EPO to issue a final written decision to this effect.
  • Announced with our collaborator, Baxter, that the U.S. Food and Drug Administration (FDA) requested additional information to complete its review of the HyQ Biologics License Application (BLA).The Companies will work together to develop studies to provide additional data to address the concerns raised by the agency.
  • In addition to filing a Line Extension Application for subcutaneous (SC) Herceptin® (trastuzumab) with the European Medicines Agency (EMA), Roche presented Phase 3 registration data from the HannaH trial at the Early Breast Cancer Conference in Vienna. The study met its co-primary endpoints of pharmacokinetics and efficacy. Herceptin SC, using rHuPH20, may provide gre
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