SAN DIEGO, Jan. 11, 2016 /PRNewswire/ -- Halozyme
Therapeutics, Inc. (NASDAQ: HALO), a biotechnology company
developing novel oncology and drug-delivery therapies, today
provided key program updates and its Annual financial guidance at
the 34th annual JP Morgan Healthcare Conference.
"We enter the year with great momentum in our expanded PEGPH20
clinical program and with our collaboration partners, including
achieving targeted enrollment in our Phase 2 study in pancreatic
cancer patients and signing our sixth ENHANZE™ global collaboration
and licensing agreement through the Lilly relationship we announced
last month," said Dr. Helen Torley,
president and chief executive officer. "In 2016, we will continue
to invest to advance our study of the pan-tumor potential of
PEGPH20, and to further expand the value of our growing ENHANZE
franchise."
Program updates and recent highlights include:
- Achieving target enrollment in Stage 2 of Halozyme Study
202 of investigational new drug PEGPH20 in metastatic pancreatic
ductal adenocarcinoma patients. Halozyme has enrolled approximately
120 patients through the end of 2015. The company remains blinded
to the efficacy results and projects presentation of mature
progression-free survival data in the event driven study in the
fourth quarter of 2016.
- Reporting a continued reduction in the rate of
thromboembolic (TE) events in the PEGPH20 treatment arm in
Stage 2 of Study 202. With patient data through Dec. 15, 2015, Halozyme reported a TE event rate
in the PEGPH20 arm of 12 percent (9 out of 73 patients) compared to
the previously reported 42 percent (31 out of 74 patients) in Stage
1 of the study. Halozyme amended the study protocol in 2014,
including the addition of prophylactic administration of low
molecular weight heparin (enoxaparin) in both treatment arms based
on a reported potential imbalance of TE events in the study.
The TE event rate in both stages
and arms of the study are:
|
Enoxaparin
Prophylaxis
Dose
|
TE Event
Rate
|
PEGPH20 +
ABRAXANE,
gemcitabine
arm
|
ABRAXANE,
gemcitabine
arm
|
Stage 1
(through Dec. 5,
2014)
|
N/A
|
42% (n=74)
|
25%
(n=61)
|
Stage 2
(through Dec. 15,
2015)
|
40 mg/day;
or,
40 mg/day increased
to
1
mg/kg/day
|
28%
(n=18)
|
29%
(n=7)
|
Started on 1
mg/kg/day
|
7%
(n=55)
|
4%
(n=27)
|
TOTAL – Stage
2
|
12%
(n=73)
|
9%
(n=34)
|
- Progressing toward HALO-301 | Pancreatic study start,
the company provided an update on the Phase 3 trial design
selecting approximately 200 sites in 20 countries concentrated in
North America, Europe, South
America and Asia Pacific.
The protocol and statistical design have been reviewed by the
majority of participating countries, including the U.S. and
multiple E.U. member states through the voluntary harmonization
procedure (VHP).
The trial is powered for two
primary endpoints, progression-free survival (PFS) and overall
survival. Statistical powering to support PFS is based on achieving
a hazard ratio of 0.59
- Advancing development of the companion diagnostic test
to prospectively identify patients with high levels of hyaluronan,
or HA.
Halozyme has partnered with
Ventana to develop the companion diagnostic and today announced the
methodology and scoring algorithm have been finalized. Based on the
cutpoint for the Ventana diagnostic, Halozyme now expects
approximately 35 to 40 percent of metastatic pancreatic cancer
patients to have high-HA tumors, similar to the previously reported
interim results from Stage 1 of its Phase 2 study using the
Halozyme prototype assay.
Analysis of biopsy samples from
patients in Stage 1 of Study 202 with the new diagnostic show a PFS
benefit in the PEGPH20 arm with a hazard ratio of 0.48.
- Signing last month a global collaboration and licensing
agreement with Eli Lilly and Company to develop and
commercialize products combining proprietary Lilly compounds with
Halozyme's ENHANZE™ platform. The agreement – Halozyme's third in
12 months – is for up to 5 collaboration targets using Halozyme's
proprietary ENHANZE technology platform and is valued at up to
$160 million for each target. The
agreement included an upfront payment of $25
million.
- Securing $150 million in
non-dilutive financing through a royalty-backed debt
transaction announced January 4.
Halozyme also provided financial guidance today for 2016,
including:
- Revenue of $110 million to $125
million, excluding revenue from any new ENHANZE global
collaboration and licensing agreements that may be signed during
the year. In 2015, Halozyme recorded $48
million for new ENHANZE partner upfront payments that was
not included in 2015 guidance issued at the beginning of the year
from initiation of agreements with AbbVie in June and Lilly in
December.
- Operating Expenses of $240 million to
$260 million, supporting the initiation of the Phase 3
study in metastatic pancreatic cancer patients and the continued
execution of clinical programs to study the pan-tumor potential of
PEGPH20 in non-small cell lung cancer, gastric and breast
cancers.
- Cash flow of $35 million to $55
million, which assumes receipt in January of
$25 million upfront payment from
Lilly and $150M from the Royalty
Backed Debt Financing.
- Year-end cash balance of $140 million
to $160 million.
Halozyme will present at 4 p.m.
PST on Tuesday, Jan. 12 at the
JP Morgan Healthcare Conference. The presentation will be
webcast through the "Investors" section of Halozyme's corporate
website at www.halozyme.com, and a recording will be made available
for 90 days following the event. To access the live webcast, please
log on to Halozyme's website approximately fifteen minutes prior to
the presentation to register and download any necessary audio
software.
About Study 202
Study 202 (Halo 109-202) is a phase 2 multi-center, randomized
clinical trial evaluating investigational new drug PEGPH20 as a
first-line therapy for potential treatment of patients with
metastatic pancreatic cancer. The primary outcome of the trial is
to measure improvement in progression-free survival in patients
receiving investigational new drug PEGPH20 in combination with
gemcitabine and ABRAXANE (nab-paclitaxel) compared to gemcitabine
and ABRAXANE alone. A second primary endpoint will assess the TE
event rate in the PEGPH20 treatment arm. Secondary endpoints also
include objective response rate and overall survival. More
information may be found at:
http://oncologytrials.halozyme.com/pancreatic/
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.
FDA granted orphan drug designation to PEGPH20 for treatment of
pancreatic cancer and fast track for PEGPH20 in combination with
gemcitabine and nab-paclitaxel for the treatment of metastatic
pancreatic 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 pancreatic
cancer.
About ENHANZE™
ENHANZE™ is Halozyme's proprietary drug delivery
platform based on its patented, FDA-approved recombinant human
hyaluronidase enzyme (rHuPH20) injection. The ENHANZE platform
enables rHuPH20 to be co-administered with other biologics for both
research and commercialization purposes. The combination of ENHANZE
with some intravenously administered biologics and compounds offers
the potential benefit of enabling subcutaneous delivery. In other
cases, combining with ENHANZE may reduce the number of injections
required for some subcutaneously administered biologics. For
approved prescribing information for approved rHuPH20, visit
www.hylenex.com.
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 (including, without
limitation, statements concerning the Company's future expectations
and plans for growth in 2016, timing and results of clinical
trials, the development and commercialization of product candidates
and the potential benefits and attributes of such product
candidates and expected financial outlook for 2016) 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 from collaborators or product
sales, unexpected clinical trial delays or results, including
enrollment delays, unexpected results or delays in development of
product candidates 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
November 9, 2015. Halozyme does not
undertake to update its forward-looking statements.
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.