Welcome!

News Feed Item

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.



Source: Eisai

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

More Stories By JCN Newswire

Copyright 2008 JCN Newswire. All rights reserved. Republication or redistribution of JCN Newswire content is expressly prohibited without the prior written consent of JCN Newswire. JCN Newswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
SYS-CON Events announced today that AppNeta, the leader in performance insight for business-critical web applications, will exhibit and present at SYS-CON's @DevOpsSummit at Cloud Expo New York, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. AppNeta is the only application performance monitoring (APM) company to provide solutions for all applications – applications you develop internally, business-critical SaaS applications you use and the networks that deli...
Join us at Cloud Expo | @ThingsExpo 2016 – June 7-9 at the Javits Center in New York City and November 1-3 at the Santa Clara Convention Center in Santa Clara, CA – and deliver your unique message in a way that is striking and unforgettable by taking advantage of SYS-CON's unmatched high-impact, result-driven event / media packages.
With major technology companies and startups seriously embracing IoT strategies, now is the perfect time to attend @ThingsExpo 2016 in New York and Silicon Valley. Learn what is going on, contribute to the discussions, and ensure that your enterprise is as "IoT-Ready" as it can be! Internet of @ThingsExpo, taking place Nov 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA, is co-located with 17th Cloud Expo and will feature technical sessions from a rock star conference faculty ...
SYS-CON Events announced today that BMC Software has been named "Siver Sponsor" of SYS-CON's 18th Cloud Expo, which will take place on June 7-9, 2015 at the Javits Center in New York, New York. BMC is a global leader in innovative software solutions that help businesses transform into digital enterprises for the ultimate competitive advantage. BMC Digital Enterprise Management is a set of innovative IT solutions designed to make digital business fast, seamless, and optimized from mainframe to mo...
In the rush to compete in the digital age, a successful digital transformation is essential, but many organizations are setting themselves up for failure. There’s a common misconception that the process is just about technology, but it’s not. It’s about your business. It shouldn’t be treated as an isolated IT project; it should be driven by business needs with the committed involvement of a range of stakeholders.
18th Cloud Expo, taking place June 7-9, 2016, at the Javits Center in New York City, NY, will feature technical sessions from a rock star conference faculty and the leading industry players in the world. Cloud computing is now being embraced by a majority of enterprises of all sizes. Yesterday's debate about public vs. private has transformed into the reality of hybrid cloud: a recent survey shows that 74% of enterprises have a hybrid cloud strategy. Meanwhile, 94% of enterprises are using some...
SoftLayer operates a global cloud infrastructure platform built for Internet scale. With a global footprint of data centers and network points of presence, SoftLayer provides infrastructure as a service to leading-edge customers ranging from Web startups to global enterprises. SoftLayer's modular architecture, full-featured API, and sophisticated automation provide unparalleled performance and control. Its flexible unified platform seamlessly spans physical and virtual devices linked via a world...
The IoTs will challenge the status quo of how IT and development organizations operate. Or will it? Certainly the fog layer of IoT requires special insights about data ontology, security and transactional integrity. But the developmental challenges are the same: People, Process and Platform. In his session at @ThingsExpo, Craig Sproule, CEO of Metavine, will demonstrate how to move beyond today's coding paradigm and share the must-have mindsets for removing complexity from the development proc...
In his keynote at 18th Cloud Expo, Andrew Keys, Co-Founder of ConsenSys Enterprise, will provide an overview of the evolution of the Internet and the Database and the future of their combination – the Blockchain. Andrew Keys is Co-Founder of ConsenSys Enterprise. He comes to ConsenSys Enterprise with capital markets, technology and entrepreneurial experience. Previously, he worked for UBS investment bank in equities analysis. Later, he was responsible for the creation and distribution of life ...
SYS-CON Events announced today that Isomorphic Software will exhibit at SYS-CON's [email protected] at Cloud Expo New York, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. Isomorphic Software provides the SmartClient HTML5/AJAX platform, the most advanced technology for building rich, high-productivity enterprise web applications for any device. SmartClient couples the industry’s broadest, deepest UI component set with a java server framework to deliver an end-...
SYS-CON Events announced today that Tintri Inc., a leading producer of VM-aware storage (VAS) for virtualization and cloud environments, will exhibit at the 18th International CloudExpo®, which will take place on June 7-9, 2016, at the Javits Center in New York City, New York, and the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA.
Designing IoT applications is complex, but deploying them in a scalable fashion is even more complex. A scalable, API first IaaS cloud is a good start, but in order to understand the various components specific to deploying IoT applications, one needs to understand the architecture of these applications and figure out how to scale these components independently. In his session at @ThingsExpo, Nara Rajagopalan is CEO of Accelerite, will discuss the fundamental architecture of IoT applications, ...
SYS-CON Events announced today that Commvault, a global leader in enterprise data protection and information management, has been named “Bronze Sponsor” of SYS-CON's 18th International Cloud Expo, which will take place on June 7–9, 2016, at the Javits Center in New York City, NY, and the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Commvault is a leading provider of data protection and information management...
The IoT is changing the way enterprises conduct business. In his session at @ThingsExpo, Eric Hoffman, Vice President at EastBanc Technologies, discuss how businesses can gain an edge over competitors by empowering consumers to take control through IoT. We'll cite examples such as a Washington, D.C.-based sports club that leveraged IoT and the cloud to develop a comprehensive booking system. He'll also highlight how IoT can revitalize and restore outdated business models, making them profitable...
SYS-CON Events announced today Object Management Group® has been named “Media Sponsor” of SYS-CON's 18th International Cloud Expo, which will take place on June 7–9, 2016, at the Javits Center in New York City, NY, and the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA.