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Halozyme Reports Second Quarter 2012 Financial Results
Date:8/6/2012

SAN DIEGO, Aug. 6, 2012 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) today reported financial results for the quarter ended June 30, 2012.

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"With receipt of the complete response letter for the HyQ BLA, we will be working to address the questions raised by FDA's Blood Products Division regarding the subcutaneous plasma derivatives programs," said Gregory I. Frost, Ph.D., President and Chief Executive Officer, Halozyme. "We are also pleased that after a review of the most recent safety data submitted, we have confirmation from FDA's Drug Division that no action is required on our approved product, Hylenex, or clinical programs under the Hylenex IND."

Second Quarter Highlights
Highlights of Halozyme's second quarter activities and recent events include:

  • Confirmed that Baxter received a complete response letter for the HyQ Biologics License Application (BLA) requesting additional preclinical data to support the application.  Additionally, the Blood Products Division requested that patients no longer be dosed with recombinant human hyaluronidase (rHuPH20) in the Baxter and ViroPharma subcutaneous plasma derivative programs, pending review of preclinical data.
  • Based on the most recent data submitted to FDA's Drug Division (the group regulating the other investigational rHuPH20 programs, including insulin and PEGPH20), the division has confirmed that no action is required against Hylenex or ongoing clinical programs under the Hylenex IND.
  • Roche announced that the Phase 3 study of the subcutaneous (SC) formulation of MabThera® (rituxumab with rHuPH20) met its primary endpoint of non-inferior MabThera serum concentrations after SC injection, compared with MabThera IV infusion
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