SAN DIEGO, Jan. 9, 2017 /PRNewswire/ -- Halozyme
Therapeutics, Inc. (NASDAQ: HALO), a biotechnology company
developing novel oncology and drug-delivery therapies, today
provided program updates and its annual financial guidance at the
35th annual JP Morgan Healthcare Conference.
"We enter the year with strongly supportive data from our HALO
202 study in metastatic pancreatic cancer patients and momentum in
our HALO 301 global registration trial for our investigational new
drug PEGPH20 in a similar, targeted HA-High patient population,"
said Dr. Helen Torley, president and
chief executive officer. "In 2017 we expect to make continued
progress demonstrating the pan-tumor potential of PEGPH20, as we
also focus on near-term catalysts in our revenue-generating
ENHANZE™ platform, including the potential approval of rituximab SC
in the U.S. and progressing other partnered programs in the
clinic."
In addition to HALO 301, the company has ongoing studies of
PEGPH20 in combination with Merck's KEYTRUDA®
(pembrolizumab) in gastric and non-small-cell lung cancer patients
and in collaboration with Eisai in combination with
HALAVEN® (eribulin) in breast cancer patients. Two new
studies exploring four tumor types are planned to start in 2017 as
part of a recently announced clinical collaboration with Genentech.
Under the collaboration, Genentech will evaluate PEGPH20 in
combination with its anti-PDL1 TECENTRIQ® (atezolizumab)
in pancreas and gastric cancer and Halozyme will evaluate the same
combination in gallbladder cancer and cholangiocarcinoma. Halozyme
has also been included in an innovative, patient-centered clinical
trial planned for initiation in 2017 called Precision Promise, led
by the Pancreatic Cancer Action Network.
In the Halozyme ENHANZE™ platform business, the company
announced in November 2016 that the
U.S. Food and Drug Administration (FDA) has accepted Genentech's
Biologics License Application for a subcutaneous formulation of
rituximab in multiple blood cancer indications with an action date
in June. This is a co-formulation with Halozyme's proprietary
recombinant human hyaluronidase enzyme (ENHANZE platform), approved
and marketed under the MabThera® SC brand in countries
outside the U.S.
In addition, Halozyme plans in 2017 to support ongoing
development of subcutaneous formulations for Roche's
PERJETA® and Janssen's DARZALEX®, work with
existing ENHANZE platform partners to advance development of
additional licensed targets, and seek to sign new global licensing
and collaboration agreements.
The company also provided financial guidance for 2017 of:
- Revenue of $115 million to $130
million, excluding revenue from any new ENHANZE global
collaboration and licensing agreements that may be signed during
the year. The company expects to report $20
million in 2016 revenue for reimbursed partner R&D
expenses that will not recur in 2017;
- Operating Expenses of $240 million to
$250 million, supporting the ongoing Phase 3 study in
metastatic pancreatic cancer patients and the continued execution
of clinical programs to study the pan-tumor potential of
PEGPH20;
- Year-end cash balance of $100 million
to $110 million.
Dr. Torley will present at 3 p.m.
PST, Jan. 9 at the conference.
Her presentation will be webcast through the "Investors" section of
www.halozyme.com, and a recording will be made available for 90
days following the event. To access the live webcast, please log on
approximately fifteen minutes prior to the presentation to register
and download any necessary audio software.
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 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 and Lilly for its ENHANZE™ drug delivery platform. 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 concerning the Company's future expectations and plans
for 2017, timing and results of clinical trials, the development
and commercialization of product candidates and the potential
benefits and attributes of such product candidates (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). These statements also include
forward-looking statements concerning 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, the product development
efforts of our ENHANZE partners, 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. The forward
looking statements also include the Company's expected financial
outlook for 2017 and statements concerning expectations for 2016
revenue for reimbursed partner R&D expenses. These
forward looking statements 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 from collaborators
or product sales, audited 2016 financial results differing from the
financial results stated above, unexpected clinical trial delays or
results, including enrollment delays, 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.
Contacts:
Jim
Mazzola
858-704-8122
ir@halozyme.com
Chris Burton
858-704-8352
ir@halozyme.com
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SOURCE Halozyme Therapeutics, Inc.