Eisai Inc. Divests U.S. Rights for GLIADEL® Wafer (polifeprosan 20 with
carmustine implant) to Arbor Pharmaceuticals
WOODCLIFF LAKE, N.J. and ATLANTA, Dec. 17, 2012
WOODCLIFF LAKE, N.J. and ATLANTA, Dec. 17, 2012 /PRNewswire/ --Eisai Inc.,
the U.S. pharmaceutical subsidiary of Eisai Co., Ltd., today announced that it
has entered into a definitive asset purchase agreement to divest U.S. rights
for Gliadel® Wafer (polifeprosan 20 with carmustine implant) to specialty
pharmaceutical company Arbor Pharmaceuticals, Inc. As part of the
transaction, which takes effect immediately, Eisai has transferred the New
Drug Application (NDA) for Gliadel to Arbor, with Arbor assuming
responsibilities for all regulatory obligations and further development
associated with the product in the United States. Eisai will retain all
rights to Gliadel outside of the United States.
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In addition, the companies have entered into a long-term supply agreement
under which Eisai shall serve as Arbor's exclusive supplier of Gliadel for the
U.S. market. Under the agreement, Eisai will manufacture Gliadel at its
facility in Baltimore, Maryland, and will sell finished product to Arbor.
"The transition of U.S. rights for Gliadel to Arbor will ensure that patients
who may benefit from treatment with Gliadel will continue to have access to
it, while also enabling Eisai to reallocate funding and resources to other
areas of our business to support our long-term business objectives," said
Lonnel Coats, President & CEO of Eisai Inc. "As a human health care company,
Eisai's focus is always on the needs of patients and their families. As such,
we are very pleased that Arbor will be taking the lead on commercializing
Gliadel in the U.S. moving forward."
"We are excited about our acquisition of U.S. rights to Gliadel and look
forward to providing this important product to patients in the United States,"
said Jason Wild, Chairman of the Board of Arbor Pharmaceuticals, Inc. "We
believe Gliadel has significant room to grow by maximizing its current use in
all appropriate patients and through additional clinical studies for expanded
indications. We expect Gliadel to fit in well with the hospital franchise
being built at Arbor, which includes our new drug application (NDA) filed for
the approval of an orphan-designated product, nimodipine oral solution."
"As part of the transaction Arbor will assume control of the contract sales
team promoting Gliadel in the U.S. with plans to increase the promotional and
medical support behind the product. In addition to Gliadel, this team will
promote nimodipine oral solution and other future hospital-based products once
approved. Arbor will continue to support the Gliadel clinical studies
underway and pursue additional clinical development opportunities," added Ed
Schutter, President & CEO of Arbor.
About GLIADEL® Wafer (polifeprosan 20 with carmustine implant)
GLIADEL® Wafer is indicated in patients with newly diagnosed high-grade
malignant glioma as an adjunct to surgery and radiation.
GLIADEL Wafer is also indicated in patients with recurrent glioblastoma
multiforme as an adjunct to surgery.
Important Safety Information for GLIADEL® Wafer (polifeprosan 20 with
GLIADEL® Wafer (polifeprosan 20 with carmustine implant) should not be given
to patients who have demonstrated a previous hypersensitivity to carmustine or
any of the components of GLIADEL Wafer.
Patients undergoing craniotomy for malignant glioma and implantation of
GLIADEL Wafer should be monitored closely for known complications of
craniotomy, including seizures, intracranial infections, abnormal wound
healing, and brain edema. Cases of intracerebral mass effect unresponsive to
corticosteroids have been described in patients treated with GLIADEL Wafer,
including one case leading to brain herniation.
Carmustine, the active component of GLIADEL Wafer, can cause fetal harm when
administered to a pregnant woman. It is recommended that patients receiving
GLIADEL Wafer discontinue nursing.
Communication between the surgical resection cavity and the ventricular system
should be avoided to prevent the wafers from migrating into the ventricular
system and causing obstructive hydrocephalus. If a communication larger than
the diameter of a wafer exists, it should be closed prior to wafer
CT and MRI of the head may demonstrate enhancement in the brain tissue
surrounding the resection cavity after implantation of GLIADEL Wafer. This
enhancement may represent edema and inflammation caused by GLIADEL Wafer or
The short-term and long-term toxicity profiles of GLIADEL Wafer when given in
conjunction with chemotherapy have not been fully explored.
The following four categories of adverse events are possibly related to
treatment with GLIADEL® Wafer (polifeprosan 20 with carmustine implant):
oSeizures: In the initial surgery trial, the incidence of seizures was
33.3% in patients receiving GLIADEL Wafer and 37.5% in patients receiving
placebo. Grand mal seizures occurred in 5% of GLIADEL Wafer–treated
patients and 4.2% of placebo-treated patients. The incidence of seizures
within the first 5 days after wafer implantation was 2.5% in the GLIADEL
Wafer group and 4.2% in the placebo group. In the surgery for recurrent
disease trial, the incidence of post-operative seizures was 19% in both
patients receiving GLIADEL Wafer and placebo. In this study, 12/22 (54%)
of patients treated with GLIADEL Wafer and 2/22 (9%) of placebo patients
experienced the first new or worsened seizure within the first 5
post-operative days. The median time to onset of the first new or
worsened post-operative seizure was 3.5 days in patients treated with
GLIADEL Wafer and 61 days in placebo patients.
oBrain Edema: In the initial surgery trial, brain edema was noted in 22.5%
of patients treated with GLIADEL Wafer and in 19.2% of patients treated
with placebo. Development of brain edema with mass effect (due to tumor
recurrences, intracranial infection, or necrosis) may necessitate
re-operation and, in some cases, removal of GLIADEL Wafer or its remnants.
oHealing Abnormalities: The following healing abnormalities have been
reported in GLIADEL Wafer clinical trials: wound dehiscence, delayed wound
healing, subdural, subgaleal or wound effusions, and cerebrospinal fluid
leak. In the initial surgery trial, healing abnormalities occurred in
15.8% of GLIADEL Wafer-treated patients and in 11.7% of placebo
recipients. Cerebrospinal fluid leaks occurred in 5% of GLIADEL Wafer
recipients and 0.8% of those given placebo.
During surgery, a water-tight dural closure should be obtained to minimize
the risk of cerebrospinal fluid leak. In the surgery for recurrent disease
trial, the incidence of healing abnormalities was 14% in GLIADEL
Wafer-treated patients and 5% in patients receiving placebo wafers.
oIntracranial Infection: In the initial surgery trial, the incidence of
brain abscess or meningitis was 5% in patients treated with GLIADEL Wafer
and 6% in patients receiving placebo. In the recurrent setting, the
incidence of brain abscess or meningitis was 4% in GLIADEL Wafer patients
and 1% in patients receiving placebo.
Please see Full Prescribing Information.
Eisai Inc. was established in 1995 and began marketing its first product in
the United States in 1997. Since that time, Eisai Inc. has rapidly grown to
become a fully integrated pharmaceutical business. Eisai's key areas of
commercial focus are neurology and oncology. The company serves as the U.S.
pharmaceutical operation of Eisai Co., Ltd., a research-based human health
care (hhc) company that discovers, develops and markets products throughout
Eisai has a global product creation organization that includes U.S.-based R&D
facilities in Massachusetts, New Jersey, North Carolina and Pennsylvania, as
well as manufacturing facilities in Maryland and North Carolina. The company's
areas of R&D focus include neuroscience; oncology; vascular, inflammatory and
immunological reaction; and antibody-based programs. For more information
about Eisai, please visit www.eisai.com/US.
Eisai Co., Ltd.
Eisai Co., Ltd. is a research-based human health care (hhc) company that
discovers, develops and markets products throughout the world. Through a
global network of research facilities, manufacturing sites and marketing
subsidiaries, Eisai actively participates in all aspects of the worldwide
About Arbor Pharmaceuticals, Inc.
Arbor Pharmaceuticals, headquartered in Atlanta, Georgia, is a specialty
pharmaceutical company currently focused on the cardiovascular, pediatric and
hospital markets. The company intends to become a leading specialty
pharmaceutical company by actively licensing, developing and commercializing
late-stage products for specialty focused conditions. Arbor currently markets
multiple NDA and ANDA approved products with several more in development. For
more information regarding Arbor Pharmaceuticals or any of its products, visit
www.arborpharma.comor send email inquiries to firstname.lastname@example.org.
Eisai Inc. Arbor Pharmaceuticals
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908-442-6103 201-746-2177 404-496-5915 678-334-2423
SOURCE Eisai Inc.
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