Noblepharma and Eisai Announce Japan Lunch of Antineoplastic Age

Noblepharma and Eisai Announce Japan Lunch of Antineoplastic Agent Gliadel(R)
7.7 mg Implant 
Tokyo, Jan 8, 2013 - (JCN Newswire) - Nobelpharma Co., Ltd. and Eisai Co., Ltd.
announced today that the two companies will launch Gliadel(R) 7.7 mg Implant
(carmustine), an antineoplastic agent, in Japan on January 9. 
Based on an existing license agreement between the companies, Nobelpharma has
been conducting clinical studies of the agent and in 2012 acquired
manufacturing and marketing authorization for Gliadel 7.7 mg Implant in Japan
on September 28 and National Health Insurance (NHI) Drug Price List
registration on November 22. Gliadel 7.7 mg Implant will be marketed
domestically by Eisai and co-promoted by both companies. 
Gliadel is the only sustained-release formulation approved for intracranial
implantation in Japan. Each wafer contains carmustine, a nitrosourea alkylating
agent, distributed in a biodegradable polymer matrix. Implanting the wafer into
the brain following surgical removal of malignant glioma allows direct delivery
of chemotherapy to the tumor site. The agent can thus be used prior to
initiating other standard therapies such as radiation and chemotherapy. In
Phase III clinical studies conducted outside Japan, Gliadel was shown to
significantly extend overall survival in patients with newly diagnosed
malignant glioma versus placebo as well as significantly increase the overall
survival rate after six months in patients with recurrent glioblastoma.
Furthermore, clinical studies conducted in Japan have demonstrated that the
agent possesses excellent antitumor efficacy and a favorable safety profile in
patients with newly diagnosed malignant glioma and recurrent glioblastoma.
Gliadel is currently approved in 30 countries worldwide, including the United
States and in Europe and Southeast Asia. 
Glioma is a tumor of the brain that accounts for approximately 30% of all
primary brain tumors, of which malignant glioma prevalence in Japan is
estimated to be about 2,000 to 2,500 cases per year. Gliadel was designated as
being of high medical need by the Investigational Committee for Usage of
Unapproved Drugs in Japan in September 2008 and designated as an orphan drug in
June 2009. 
Malignant glioma remains difficult to treat and the two companies expect
Gliadel 7.7 mg Implant to become a new treatment option for patients with
malignant glioma. In accordance with approval conditions, the two companies
will work together to conduct a post-marketing use results survey (all-case
surveillance) in patients who are administered Gliadel 7.7 mg Implant until the
predetermined number of patients has been reached, in order to promote the
effective and safe use of the drug. 
About Glioma 
Glioma is the general term for primary brain tumors originating from the glial
cells that exist in essential brain tissue. They are mostly malignant with poor
prognosis. Gliomas account for approximately 30% of all primary brain tumors
and in many cases characteristically spread and develop (infiltrate) in the
brain or spinal cord without a distinct tumor boundary, with normal brain
tissue and tumor cells being both present in surrounding areas making it
difficult to remove the tumor completely. In these cases, the tumor has a poor
survival prognosis of 25% or less within the first five years. 
Surgical removal (craniotomy) of the tumor is usually performed as standard
treatment for glioma and in the majority of cases radiation and/or chemotherapy
is administered adjunctively post-surgery. However, the active ingredients in
chemotherapeutic agents administered during systemic chemotherapy regimens are
often unable to be sufficiently delivered to the tumor site at the required
dose because of the blood-brain barrier and the actual dose required also
cannot be sufficiently administered without systemic adverse events. These
difficulties are another reason for poor prognosis in patients with malignant
glioma. 
About the Clinical Study Conducted in Japan (NPC-08-01) 
NPC-08-01 was a multicenter, non-comparative, non-blind study conducted with
the aim of evaluating the drug's efficacy and safety in 16 patients with
newly diagnosed malignant glioma ("newly diagnosed patients") and 8
patients with recurrent glioblastoma ("recurrent patients"). A
maximum of eight wafers were placed in the resection cavity at the time of
surgical removal and, 14 days after implantation, the newly diagnosed patients
were administered temozolomide and radiation as adjunctive therapies and the
recurrent patients were administered appropriate therapies (mainly
temozolomide). Survival rates and safety were evaluated at 6 and 12 months
after implantation, respectively. The survival rate for newly diagnosed
patients after 12 months was 100.0% (16/16 cases) and the survival rate for
recurrent patients after 6 months was 87.5% (7/8 cases) and after 12 months
62.5% (5/ 8 cases). 
Furthermore, the rate of adverse events occurring (including laboratory
abnormalities) was 54.2% (13/24 cases), with the most common adverse events
being: brain edema (25.0%, 6/24 cases), fever (12.5%, 3/24 cases),
lymphocytopenia (12.5%, 3/24 cases), hemiplegia (including hemiparesis) (12.5%,
3/24 cases), nausea (8.3%, 2/24 cases), vomiting (8.3%, 2/24 cases), loss of
appetite (8.3%, 2/24 cases), headache (8.3%, 2/24 cases), and increased ALT
(GPT) (8.3%, 2/24 cases). 
About the Phase III Clinical Studies Conducted Outside Japan (T-301 and 8802) 
Study T-301 was a multicenter, randomized, double-blind, placebo-controlled
study that compared the efficacy and safety of Gliadel versus placebo in 240
newly diagnosed patients. Results from the study recorded a median overall
survival rate of 13.9 months for Gliadel and 11.6 months for placebo, with
significant improvement for Gliadel (p=0.03). Adverse events occurred at a rate
of 55.8% (67/120 cases) for Gliadel and 60.8% (73/120 cases) for placebo. Study
8802 was a multicenter, randomized, double-blind, placebo-controlled,
comparative clinical study in 222 recurrent patients. Results of this study
recorded a survival rate after six months of 60.0% for Gliadel and 47.3% for
placebo (p=0.06), with a median overall survival rate of 7.24 months for
Gliadel and 5.42 months for placebo (p=0.30). However, in an analysis of just
the 145 patients diagnosed with glioblastoma, the survival rate after six
months was 55.6% for Gliadel and 35.6% for placebo, with a significant
difference favoring Gliadel (p=0.02), while the median overall survival rate
was 6.4 months for Gliadel and 4.6 months for placebo. Adverse events occurred
at a rate of 60.9% (67/110 cases) for Gliadel and 63.4% (71/112 cases) for
placebo. 
About Eisai 
Eisai Co., Ltd. (TSE: 4523; ADR: ESALY) is a research-based human health care
(hhc) company that discovers, develops and markets products throughout the
world. Eisai focuses its efforts in three therapeutic areas: integrative
neuroscience, including neurology and psychiatric medicines; integrative
oncology, which encompasses oncotherapy and supportive-care treatments; and
vascular/immunological reaction. Through a global network of research
facilities, manufacturing sites and marketing subsidiaries, Eisai actively
participates in all aspects of the worldwide healthcare system. For more
information about Eisai Co., Ltd., please visit www.eisai.com. 
Contact: 
Eisai Co., Ltd.
Public Relations Department
+81-3-3817-5120 
Nobelpharma Co., Ltd.
Corporate Planning Department
+81-3-5651-1160 
Copyright 2012 JCN Newswire. All rights reserved. www.japancorp.net 
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