Click here to close now.


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

Source: Eisai

Eisai Co., Ltd.
Public Relations Department

Nobelpharma Co., Ltd.
Corporate Planning Department

Copyright 2012 JCN Newswire. All rights reserved.

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
We all know that data growth is exploding and storage budgets are shrinking. Instead of showing you charts on about how much data there is, in his General Session at 17th Cloud Expo, Scott Cleland, Senior Director of Product Marketing at HGST, showed how to capture all of your data in one place. After you have your data under control, you can then analyze it in one place, saving time and resources.
Today air travel is a minefield of delays, hassles and customer disappointment. Airlines struggle to revitalize the experience. GE and M2Mi will demonstrate practical examples of how IoT solutions are helping airlines bring back personalization, reduce trip time and improve reliability. In their session at @ThingsExpo, Shyam Varan Nath, Principal Architect with GE, and Dr. Sarah Cooper, M2Mi’s VP Business Development and Engineering, explored the IoT cloud-based platform technologies driving t...
As organizations shift towards IT-as-a-service models, the need for managing & protecting data residing across physical, virtual, and now cloud environments grows with it. CommVault can ensure protection & E-Discovery of your data - whether in a private cloud, a Service Provider delivered public cloud, or a hybrid cloud environment – across the heterogeneous enterprise.
In recent years, at least 40% of companies using cloud applications have experienced data loss. One of the best prevention against cloud data loss is backing up your cloud data. In his General Session at 17th Cloud Expo, Sam McIntyre, Partner Enablement Specialist at eFolder, presented how organizations can use eFolder Cloudfinder to automate backups of cloud application data. He also demonstrated how easy it is to search and restore cloud application data using Cloudfinder.
The Internet of Things (IoT) is growing rapidly by extending current technologies, products and networks. By 2020, Cisco estimates there will be 50 billion connected devices. Gartner has forecast revenues of over $300 billion, just to IoT suppliers. Now is the time to figure out how you’ll make money – not just create innovative products. With hundreds of new products and companies jumping into the IoT fray every month, there’s no shortage of innovation. Despite this, McKinsey/VisionMobile data...
Internet of @ThingsExpo, taking place June 7-9, 2016 at Javits Center, New York City and Nov 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA, is co-located with the 18th International @CloudExpo and will feature technical sessions from a rock star conference faculty and the leading industry players in the world and ThingsExpo New York Call for Papers is now open.
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 ...
Just over a week ago I received a long and loud sustained applause for a presentation I delivered at this year’s Cloud Expo in Santa Clara. I was extremely pleased with the turnout and had some very good conversations with many of the attendees. Over the next few days I had many more meaningful conversations and was not only happy with the results but also learned a few new things. Here is everything I learned in those three days distilled into three short points.
As organizations realize the scope of the Internet of Things, gaining key insights from Big Data, through the use of advanced analytics, becomes crucial. However, IoT also creates the need for petabyte scale storage of data from millions of devices. A new type of Storage is required which seamlessly integrates robust data analytics with massive scale. These storage systems will act as “smart systems” provide in-place analytics that speed discovery and enable businesses to quickly derive meaningf...
DevOps is about increasing efficiency, but nothing is more inefficient than building the same application twice. However, this is a routine occurrence with enterprise applications that need both a rich desktop web interface and strong mobile support. With recent technological advances from Isomorphic Software and others, rich desktop and tuned mobile experiences can now be created with a single codebase – without compromising functionality, performance or usability. In his session at DevOps Su...
SYS-CON Events announced today that Alert Logic, Inc., the leading provider of Security-as-a-Service solutions for the cloud, will exhibit at 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. Alert Logic, Inc., provides Security-as-a-Service for on-premises, cloud, and hybrid infrastructures, delivering deep security insight and continuous protection for customers at a lower cost than traditional security solutions. Ful...
In his keynote at @ThingsExpo, Chris Matthieu, Director of IoT Engineering at Citrix and co-founder and CTO of Octoblu, focused on building an IoT platform and company. He provided a behind-the-scenes look at Octoblu’s platform, business, and pivots along the way (including the Citrix acquisition of Octoblu).
The buzz continues for cloud, data analytics and the Internet of Things (IoT) and their collective impact across all industries. But a new conversation is emerging - how do companies use industry disruption and technology enablers to lead in markets undergoing change, uncertainty and ambiguity? Organizations of all sizes need to evolve and transform, often under massive pressure, as industry lines blur and merge and traditional business models are assaulted and turned upside down. In this new da...
In his General Session at 17th Cloud Expo, Bruce Swann, Senior Product Marketing Manager for Adobe Campaign, explored the key ingredients of cross-channel marketing in a digital world. Learn how the Adobe Marketing Cloud can help marketers embrace opportunities for personalized, relevant and real-time customer engagement across offline (direct mail, point of sale, call center) and digital (email, website, SMS, mobile apps, social networks, connected objects).
Culture is the most important ingredient of DevOps. The challenge for most organizations is defining and communicating a vision of beneficial DevOps culture for their organizations, and then facilitating the changes needed to achieve that. Often this comes down to an ability to provide true leadership. As a CIO, are your direct reports IT managers or are they IT leaders? The hard truth is that many IT managers have risen through the ranks based on their technical skills, not their leadership ab...