SAN DIEGO, Nov. 26, 2018 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ:
HALO), a biotechnology company developing novel oncology and drug-delivery therapies, today announced that prior to data
analysis, the FDA has agreed to Halozyme's request to change the primary endpoint of the HALO-301 study to the single primary
endpoint of overall survival (OS). As a result, the previously planned interim analysis will not be conducted. The company will
host a webcast and conference call today at 5 p.m. Eastern / 2 p.m.
Pacific to discuss this change in further detail.
HALO-301 is a phase 3 global, randomized, double-blind placebo controlled clinical trial evaluating investigational new drug
PEGPH20 as a first-line therapy for potential treatment of patients with metastatic pancreas cancer.
Webcast and Conference Call
Halozyme will webcast a conference call today at 5 p.m. ET / 2 p.m.
PT to discuss the HALO-301 statistical plan. Dr. Helen Torley, president and chief
executive officer, will lead the call, which will be webcast live through the "Investors" section of Halozyme's corporate website
and a replay will be available following the close of the call. To access the webcast and additional documents related to the
call, please visit www.halozyme.com approximately fifteen
minutes prior to the call to register, download and install any necessary audio software. The call may also be accessed by
dialing (877) 410-5657 (domestic callers) or (334) 323-7224 (international callers) using passcode 387156. A telephone replay
will be available after the call by dialing (877) 919-4059 (domestic callers) or (334) 323-0140 (international callers) using
replay ID number 49634758.
About HALO 301
HALO 301 is a phase 3 global, randomized, double-blind placebo controlled clinical trial evaluating investigational new drug
PEGPH20 as a first-line therapy for potential treatment of patients with metastatic pancreas cancer. The trial will now be
conducted at approximately 200 sites with a single primary endpoint of overall survival in patients receiving investigational new
drug PEGPH20 in combination with gemcitabine and ABRAXANE® (nab-paclitaxel) compared to gemcitabine and nab-paclitaxel alone.
Secondary endpoints include progression-free survival and objective response rate. More information may be found at
clinicaltrials.gov (search HALO 301 or trial identifier NCT02715804) or www.HALO301.com.
About PEGPH20
PEGPH20 is an investigational PEGylated form of Halozyme's proprietary recombinant human hyaluronidase under clinical
development for the potential systemic treatment of tumors that accumulate hyaluronan. PEGPH20 is an enzyme that temporarily
degrades HA, a dense component of the tumor microenvironment that can accumulate in higher concentrations around certain cancer
cells, potentially constricting blood vessels and impeding the access of other therapies.
FDA granted orphan drug designation to PEGPH20 for treatment of pancreas cancer and fast track for PEGPH20 in combination with
gemcitabine and nab-paclitaxel for the treatment of metastatic pancreas cancer. Additionally, the European Commission, acting on
the recommendation from the Committee for Orphan Medicinal Products of the European Medicines Agency, designated investigational
drug PEGPH20 an orphan medicinal product for the treatment of pancreas cancer.
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 the treatment of several cancers and has the potential to be used
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 possible activity, benefits and attributes of PEGPH20, the possible method of action of
PEGPH20, its potential application to improve cancer therapies and statements concerning future actions relating to the
development of PEGPH20) 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 results or delays in development, 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 most recent Annual and Quarterly Reports filed with the Securities and Exchange Commission.
Contact:
Al Kildani
Vice President, Investor Relations and Corporate Communications
858-704-8122
akildani@halozyme.com
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SOURCE Halozyme Therapeutics, Inc.