FDA Accepts Biologics License Application For Subcutaneous Formulation Of Herceptin

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Jul 11, 2018, 08:30 ET

SAN DIEGO, July 11, 2018 /PRNewswire/ -- 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.

Safe Harbor Statement
In addition to historical information, the statements set forth above include forward-looking statements (including, without limitation, statements concerning the Company's future expectations and plans for growth in 2018, entering into new collaboration agreements, the development and commercialization of product candidates, including timing of clinical trial results announcements and future development and commercial activities of our collaboration partners, the potential benefits and attributes of such product candidates and expected financial outlook for 2018) that involve risk and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. The forward-looking statements are typically, but not always, identified through use of the words "believe," "enable," "may," "will," "could," "intends," "estimate," "anticipate," "plan," "predict," "probable," "potential," "possible," "should," "continue," and other words of similar meaning. Actual results could differ materially from the expectations contained in forward-looking statements as a result of several factors, including unexpected expenditures and costs, unexpected fluctuations or changes in revenues, including revenues from collaborators, unexpected delays in entering into new collaboration agreements, unexpected results or delays in development of product candidates, including delays in clinical trial patient enrollment and development activities of our collaboration partners, and regulatory review, regulatory approval requirements, unexpected adverse events and competitive conditions. These and other factors that may result in differences are discussed in greater detail in the Company's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 10, 2018.

Contacts:
Jim Mazzola
858-704-8122
[email protected]

Chris Burton
858-704-8352
[email protected]

SOURCE Halozyme Therapeutics, Inc.