SAN DIEGO, July 26, 2018 /PRNewswire/ -- Halozyme
Therapeutics, Inc. (NASDAQ: HALO), a biotechnology company developing novel oncology and drug-delivery therapies, today announced
that Genentech, a member of the Roche Group, has dosed the first patient in a Phase 3 study of a fixed-dose combination of
pertuzumab (Perjeta®) and trastuzumab (Herceptin®) for subcutaneous administration using Halozyme's
proprietary ENHANZE® drug-delivery technology in combination with chemotherapy.
The global Phase 3 study is investigating the combination as a single fixed-dose in patients with human epidermal growth
factor receptor 2 (HER2)-positive early breast cancer in the neoadjuvant and adjuvant settings. The estimated administration time
for the initial loading dose of the combination is 7 to 8 minutes and subsequent maintenance doses are approximately 5
minutes.
"We are excited to support the initiation by Genentech of the first Phase 3 study exploring a fixed-dose combination of two
therapeutics," said Dr. Helen Torley, president and CEO of Halozyme. "For breast cancer patients
and healthcare professionals, the approach of administering pertuzumab and trastuzumab subcutaneously in a single injection with
ENHANZE offers the potential for a new treatment administration option."
The Phase 3 study follows a Phase 1b clinical trial that assessed the safety, tolerability and
pharmacokinetics of the same fixed-dose combination presented at the 2017 San Antonio Breast Cancer Symposium.
Perjeta (pertuzumab) and Herceptin (trastuzumab) are registered trademarks of Genentech, a member of the Roche Group.
About ENHANZE Technology
Halozyme's proprietary ENHANZE drug-delivery technology is based on its patented recombinant human
hyaluronidase enzyme (rHuPH20). rHuPH20 has been shown to remove traditional limitations on the volume of biologics that can be
delivered subcutaneously (just under the skin). By using rHuPH20, some biologics and compounds that are administered
intravenously may instead be delivered subcutaneously. ENHANZE technology may also benefit subcutaneous biologics by reducing the
need for multiple injections. This delivery method has been shown in studies to reduce health care practitioner time required for
administration and shorten time for drug administration.
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:
Chris Burton
858-704-8352
ir@halozyme.com
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SOURCE Halozyme Therapeutics, Inc.