WOODCLIFF LAKE, N.J. and
SAN DIEGO, July 31, 2015 /PRNewswire/ -- Eisai Inc.
announced today that its parent company Eisai Co., Ltd.
(Headquarters: Tokyo, President
and CEO: Haruo Naito, "Eisai") and
Halozyme Therapeutics, Inc. (Headquarters: San Diego, California, President and CEO: Dr.
Helen Torley, "NASDAQ: HALO") have
signed a clinical collaboration agreement to evaluate
Eisai's agent eribulin mesylate (brand name:
Halaven®, "eribulin") in combination with Halozyme's
investigational drug PEGPH20 (PEGylated recombinant human
hyaluronidase) in first line HER2-negative metastatic breast
cancer. The companies will jointly share the costs of a phase 1b/2
clinical trial to assess whether or not eribulin, in combination
with PEGPH20, can improve overall response rate (ORR) -- the
proportion of women that have a predefined reduction in tumor
burden -- as compared with eribulin alone as a therapy in women
with advanced breast cancer.
PEGPH20 (PEGylated recombinant human hyaluronidase) is an
investigational drug administered intravenously that targets the
degradation of hyaluronan, a glycosaminoglycan – or chain of
natural sugars throughout the body – that can accumulate around
cancer cells to inhibit other therapies. The collaborative study
will seek to determine whether or not the combination therapy of
eribulin and PEGPH20 can improve the overall response rate in
patients with high levels of hyaluronan. In hyaluronan-rich
triple-negative breast preclinical animal models, the addition of
PEGPH20 to eribulin showed a significantly higher tumor growth
inhibition and overall tumor regression when compared to eribulin
alone.
Eribulin is not indicated for first-line therapy for patients
with HER2-negative metastatic breast cancer.
Eribulin is the first in the halichondrin class of microtubule
dynamics inhibitors with a novel mechanism of action. Structurally,
eribulin is a modified and synthetically produced analog of
halichondrin B, a natural product isolated from the marine sponge
Halichondria okadai. Eribulin is believed to work by
inhibition of the growth phase of microtubule dynamics which
prevents cell division.
"This is a very important collaboration, one that speaks to our
continued commitment to address the unmet medical needs of patients
with advanced breast cancer," said RuiRong
Yuan, MD, Vice President and Chief Medical Officer, Eisai
Global Oncology. "We look forward to enrolling patients in the
clinical trial and assessing the results."
"This agreement marks the first clinical collaboration agreement
for Halozyme and extends the study of PEGPH20 to a substantially
wider population of patients with a partner that is a clear leader
in the treatment of metastatic breast cancer," said Dr.
Helen Torley, President and CEO,
Halozyme Therapeutics.
The information discussed in this release presents an
investigational use for an FDA-approved product (eribulin). It is
not intended to convey conclusions about efficacy or safety. There
is no guarantee that the investigational use of the combination of
eribulin and PEGPH20 will successfully gain FDA approval.
About Advanced Breast Cancer
Advanced or
metastatic breast cancer is a very difficult condition to treat and
only 25.9% of women will survive beyond five years.
About PEGPH20
PEGPH20 is currently under development
in combination with chemotherapies for the treatment of metastatic
pancreatic cancer and non-small cell lung cancer with plans
for it to be studied in combination with an immunotherapy agent
later this year.
About Eribulin Mesylate Injection (Available as
Halaven®)
Eribulin mesylate injection is indicated for
patients with metastatic breast cancer who have received at least
two chemotherapeutic regimens for the treatment of metastatic
breast cancer. Prior therapy should have included an anthracycline
and a taxane in either the adjuvant or metastatic setting. Eribulin
is a synthetic analog of halichondrin B, a natural product that was
isolated from the marine sponge Halichondria okadai. First
in the halichondrin class, eribulin is a microtubule dynamics
inhibitor with a distinct binding profile. Based on in vitro
studies, eribulin exerts its effect via a tubulin-based antimitotic
mechanism ultimately leading to apoptotic cell death after
prolonged and irreversible mitotic blockage.
Important Safety Information
Neutropenia
- Monitor complete blood counts prior to each dose, and increase
the frequency of monitoring in patients who develop Grade 3 or 4
cytopenias. Delay administration and reduce subsequent doses in
patients who experience febrile neutropenia or Grade 4 neutropenia
lasting longer than 7 days
- Severe neutropenia (ANC <500/mm3) lasting more
than 1 week occurred in 12% (62/503) of patients. Patients with
elevated liver enzymes >3 × ULN and bilirubin >1.5 × ULN
experienced a higher incidence of Grade 4 neutropenia and febrile
neutropenia than patients with normal levels
- Grade 3 and Grade 4 neutropenia occurred in 28% and 29%,
respectively, of patients who received eribulin. Febrile
neutropenia occurred in 5% of patients and two patients (0.4%) died
from complications
Peripheral Neuropathy
- Patients should be monitored closely for signs of peripheral
motor and sensory neuropathy
- Grade 3 peripheral neuropathy occurred in 8% of patients, and
Grade 4 in 0.4% of patients who received eribulin. Delay
administration of eribulin until resolution to Grade 2 or less
- Neuropathy lasting more than 1 year occurred in 5% of patients.
Twenty-two percent of patients developed a new or worsening
neuropathy that had not recovered within a median follow-up
duration of 269 days (range 25-662 days)
- Peripheral neuropathy (5%) was the most common adverse reaction
resulting in discontinuation
Pregnancy Category D
- Eribulin is expected to cause fetal harm when administered to a
pregnant woman and patients should be advised of these risks
QT Prolongation
- In an uncontrolled ECG study in 26 patients, QT prolongation
was observed on Day 8, independent of eribulin concentration, with
no prolongation on Day 1. ECG monitoring is recommended for
patients with congestive heart failure; bradyarrhythmias;
concomitant use of drugs that prolong QT interval, including Class
Ia and III antiarrhythmics; and electrolyte abnormalities
- Correct hypokalemia or hypomagnesemia prior to initiating
eribulin and monitor electrolytes periodically during therapy.
Avoid in patients with congenital long QT syndrome
Hepatic and Renal Impairment
- For patients with mild (Child-Pugh A) or moderate (Child-Pugh
B) hepatic and/or moderate or severe (CrCl 15-49 mL/min) renal
impairment, a reduction in starting dose is recommended
Most Common Adverse Reactions
- Most common adverse reactions (≥25%) reported in patients
receiving eribulin were neutropenia (82%), anemia (58%),
asthenia/fatigue (54%), alopecia (45%), peripheral neuropathy
(35%), nausea (35%), and constipation (25%)
- The most common serious adverse reactions reported in patients
receiving eribulin were febrile neutropenia (4%) and neutropenia
(2%)
For more information about eribulin, click here for the full
Prescribing Information.
About Eisai Inc.
At Eisai Inc., human health
care is our goal. We give our first thoughts to patients and
their families, and helping to increase the benefits health care
provides. As the U.S. pharmaceutical subsidiary of Tokyo-based Eisai Co., Ltd., we have a
passionate commitment to patient care that is the driving force
behind our efforts to help address unmet medical needs. We are a
fully integrated pharmaceutical business with discovery, clinical,
manufacturing and marketing capabilities. Our key areas of
commercial focus include oncology and specialty care (Alzheimer's
disease, epilepsy and metabolic disorders). To learn more about
Eisai Inc., please visit us at www.eisai.com/US.
Eisai Inc. has affiliates that are part of a global product
creation organization that includes R&D facilities in
Massachusetts, New Jersey, North
Carolina and Pennsylvania,
as well as a global demand chain organization that includes
facilities in Maryland and
North Carolina. Eisai's global
areas of R&D focus include neuroscience; oncology; metabolic
disorders; vascular, inflammatory and immunological reaction; and
antibody-based programs.
About Eisai Co., Ltd.
Eisai Co., Ltd. is
a leading global research and development-based pharmaceutical
company headquartered in Japan. We
define our corporate mission as "giving first thought to patients
and their families and to increasing the benefits health care
provides," which we call our human health care (hhc)
philosophy. With over 10,000 employees working across our global
network of R&D facilities, manufacturing sites and marketing
subsidiaries, we strive to realize our hhc philosophy by delivering
innovative products in various therapeutic areas with high unmet
medical needs, including oncology and neurology.
As a global pharmaceutical company, our mission extends to
patients around the world through our investment and participation
in partnership-based initiatives to improve access to medicines in
developing and emerging countries. For more information about Eisai
Co., Ltd., please visit www.eisai.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, an investigational drug
PEGPH20, applies a unique approach to targeting solid tumors,
allowing increased access of co-administered cancer drug therapies
to the tumor. PEGPH20 is currently in development for
metastatic pancreatic cancer and non-small cell lung cancer and has
potential across additional cancers in combination with different
types of therapies. In addition to its proprietary product
portfolio, Halozyme has established value-driving partnerships with
leading pharmaceutical companies including Roche, Pfizer, Janssen,
Baxalta and AbbVie for its drug delivery platform, ENHANZE™, which
enables biologics and small molecule compounds that are currently
administered intravenously to be delivered subcutaneously. Halozyme
is headquartered in San Diego. For
more information, visit halozyme.com.
Media
Inquiries
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Investor
Inquiries
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Halozyme
Therapeutics
|
Eisai Inc.
|
Eisai Inc.
|
Schond Greenway /Jim
Mazzola
|
Laurie
Landau
|
Alex Scott
|
858-704-8352 /
858-704-8122
|
201-746-2510
|
201-746-2177
|
ir@halozyme.com
|
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SOURCE Eisai Inc.; Halozyme Therapeutics, Inc.