FDA Accepts Biologics License Application For Subcutaneous Formulation Of Herceptin

SAN DIEGO, CA, USA I July 11, 2018 I Halozyme Therapeutics, Inc. (NASDAQ: HALO) today announced that the U.S. Food and Drug Administration (FDA) has accepted a Biologics License Application from Genentech, a member of the Roche Group, for a subcutaneous (SC) formulation of trastuzumab (Herceptin®) in its FDA-approved breast cancer indications. This is a co-formulation with Halozyme's proprietary recombinant human hyaluronidase enzyme (ENHANZE® technology), which is approved and marketed under the Herceptin® SC brand in many countries outside the U.S.

"We are excited to see Genentech and Roche taking steps to bring a subcutaneous formulation of trastuzumab to patients in the United States," said Dr. Helen Torley, president and chief executive officer. "If approved, this formulation would provide a new treatment administration option for patients and health care practitioners."  

Roche reported total 2017 sales of Herceptin in the United States of 2.7 billion CHF. Sales of subcutaneous trastuzumab will be dependent on market adoption.

Herceptin® (trastuzumab) is a registered trademark of Genentech, a member of the Roche Group.

About Halozyme

Halozyme Therapeutics is a biotechnology company focused on developing and commercializing novel oncology therapies that target the tumor microenvironment. Halozyme's lead proprietary program, investigational drug pegvorhyaluronidase alfa (PEGPH20), applies a unique approach to targeting solid tumors, allowing increased access of co-administered cancer drug therapies to the tumor in animal models. PEGPH20 is currently in development for metastatic pancreatic cancer, non-small cell lung cancer, gastric cancer, metastatic breast cancer and has potential across additional cancers in combination with different types of cancer therapies. In addition to its proprietary product portfolio, Halozyme has established value-driving partnerships with leading pharmaceutical companies including Roche, Baxalta, Pfizer, Janssen, AbbVie, Lilly, Bristol-Myers Squibb and Alexion for its ENHANZE® drug delivery technology. Halozyme is headquartered in San Diego. For more information visit www.halozyme.com.

SOURCE: Halozyme Therapeutics

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