SAN DIEGO, Nov. 4, 2019 /PRNewswire/ -- Halozyme
Therapeutics, Inc. (NASDAQ: HALO) today announced that the HALO-301
Phase 3 clinical study evaluating investigational new drug PEGPH20
as a first-line therapy for treatment of patients with metastatic
pancreas cancer failed to reach the primary endpoint of overall
survival.
The treatment arm of PEGPH20 in combination with gemcitabine and
nab-paclitaxel (ABRAXANE®) failed to demonstrate an
improvement in median overall survival compared to gemcitabine and
nab-paclitaxel alone (11.2 months compared to 11.5 months, HR=1.00,
p=0.9692). While there was a higher response rate in the PEGPH20
treatment arm, this did not translate into an improvement in
duration of response, Progression Free Survival or Overall
Survival.
"Patients in both treatment arms of the HALO-301 trial surpassed
the published median overall survival rates from the pivotal
registration study of ABRAXANE® plus gemcitabine as
first-line therapy for metastatic pancreas cancer, published in
2013. Based on the lack of benefit over standard-of-care in
this study, which performed well versus published data, we will be
discontinuing PEGPH20 clinical development," said Dr. Helen Torley, president and CEO of Halozyme.
"This well-designed and well-executed study did not have the
outcome that we or the study participants wanted or expected. I
would like to extend a heartfelt thank you to all those who
supported and who made this study possible, including the patients
who were enrolled, their families, our investigators, their staff,
our investors and all of the dedicated Halozyme employees."
Halozyme intends to halt development activities for PEGPH20 and
implement an organizational restructuring to focus its operations
solely on its ENHANZE® drug delivery technology.
Further details regarding the organizational restructuring and
other strategic actions to position Halozyme for the future can be
found in a separate press release issued today.
Conference Call and Webcast Information
Halozyme will
webcast a conference call today at 8:30 a.m.
ET / 5:30 a.m. PT to discuss
its plans to focus strategy on its ENHANZE® drug
delivery technology. 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, 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) 824-0907
(domestic callers) or (647) 689-5655 (international callers) using
passcode 3069304. A telephone replay will be available after the
call by dialing (800) 585-8367 (domestic callers) or (416) 621-4642
(international callers) using replay ID number 3069304.
About Halozyme
Halozyme Therapeutics is a
biotechnology that has established value-driving partnerships with
leading pharmaceutical companies including Roche, Baxalta, Pfizer,
Janssen, AbbVie, Lilly, Bristol-Myers Squibb, Alexion and argenx
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 plans to implement
an organizational restructuring and to focus its operations solely
on its ENHANZE® drug delivery technology.
Forward-looking statements regarding the Company's
ENHANZE® drug delivery technology may include the
possible activity, benefits and attributes of ENHANZE®,
the possible method of action of ENHANZE®, its potential
application to aid in the dispersion and absorption of other
injected therapeutic drugs, the number of collaborative targets
actually chosen, whether such products are ultimately developed or
commercialized, whether milestones triggering milestone payments
will be achieved, and statements concerning facilitating more rapid
delivery of injectable medications through subcutaneous delivery
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 delays or results of the Company's
organizational restructuring, 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
recently filed Annual Report on Form 10-K and Quarterly Reports on
Form 10-Q filed with the Securities and Exchange Commission.
Contact:
Al Kildani
Vice President, Investor Relations and Corporate Communications
858-704-8122
ir@halozyme.com
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SOURCE Halozyme Therapeutics, Inc.