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
Choosing the right cloud for your workloads is a balancing act that can cost your organization time, money and aggravation - unless you get it right the first time. Economics, speed, performance, accessibility, administrative needs and security all play a vital role in dictating your approach to the cloud. Without knowing the right questions to ask, you could wind up paying for capacity you'll never need or underestimating the resources required to run your applications.
Web Real-Time Communication APIs have quickly revolutionized what browsers are capable of. In addition to video and audio streams, we can now bi-directionally send arbitrary data over WebRTC's PeerConnection Data Channels. With the advent of Progressive Web Apps and new hardware APIs such as WebBluetooh and WebUSB, we can finally enable users to stitch together the Internet of Things directly from their browsers while communicating privately and securely in a decentralized way.
WebRTC is about the data channel as much as about video and audio conferencing. However, basically all commercial WebRTC applications have been built with a focus on audio and video. The handling of “data” has been limited to text chat and file download – all other data sharing seems to end with screensharing. What is holding back a more intensive use of peer-to-peer data? In her session at @ThingsExpo, Dr Silvia Pfeiffer, WebRTC Applications Team Lead at National ICT Australia, looked at differ...
Adding public cloud resources to an existing application can be a daunting process. The tools that you currently use to manage the software and hardware outside the cloud aren’t always the best tools to efficiently grow into the cloud. All of the major configuration management tools have cloud orchestration plugins that can be leveraged, but there are also cloud-native tools that can dramatically improve the efficiency of managing your application lifecycle. In his session at 18th Cloud Expo, ...
Security, data privacy, reliability and regulatory compliance are critical factors when evaluating whether to move business applications from in-house client hosted environments to a cloud platform. In her session at 18th Cloud Expo, Vandana Viswanathan, Associate Director at Cognizant, In this session, will provide an orientation to the five stages required to implement a cloud hosted solution validation strategy.
The security needs of IoT environments require a strong, proven approach to maintain security, trust and privacy in their ecosystem. Assurance and protection of device identity, secure data encryption and authentication are the key security challenges organizations are trying to address when integrating IoT devices. This holds true for IoT applications in a wide range of industries, for example, healthcare, consumer devices, and manufacturing. In his session at @ThingsExpo, Lancen LaChance, vic...
With the proliferation of both SQL and NoSQL databases, organizations can now target specific fit-for-purpose database tools for their different application needs regarding scalability, ease of use, ACID support, etc. Platform as a Service offerings make this even easier now, enabling developers to roll out their own database infrastructure in minutes with minimal management overhead. However, this same amount of flexibility also comes with the challenges of picking the right tool, on the right ...
With all the incredible momentum behind the Internet of Things (IoT) industry, it is easy to forget that not a single CEO wakes up and wonders if “my IoT is broken.” What they wonder is if they are making the right decisions to do all they can to increase revenue, decrease costs, and improve customer experience – effectively the same challenges they have always had in growing their business. The exciting thing about the IoT industry is now these decisions can be better, faster, and smarter. Now ...
"Splunk basically takes machine data and we make it usable, valuable and accessible for everyone. The way that plays in DevOps is - we need to make data-driven decisions to delivering applications," explained Andi Mann, Chief Technology Advocate at Splunk and @DevOpsSummit Conference Chair, in this SYS-CON.tv interview at @DevOpsSummit at 19th Cloud Expo, held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA.
Security, data privacy, reliability, and regulatory compliance are critical factors when evaluating whether to move business applications from in-house, client-hosted environments to a cloud platform. Quality assurance plays a vital role in ensuring that the appropriate level of risk assessment, verification, and validation takes place to ensure business continuity during the migration to a new cloud platform.
In his session at @DevOpsSummit at 19th Cloud Expo, Robert Doyle, lead architect at eCube Systems, will examine the issues and need for an agile infrastructure and show the advantages of capturing developer knowledge in an exportable file for migration into production. He will introduce the use of NXTmonitor, a next-generation DevOps tool that captures application environments, dependencies and start/stop procedures in a portable configuration file with an easy-to-use GUI. In addition to captur...
Who are you? How do you introduce yourself? Do you use a name, or do you greet a friend by the last four digits of his social security number? Assuming you don’t, why are we content to associate our identity with 10 random digits assigned by our phone company? Identity is an issue that affects everyone, but as individuals we don’t spend a lot of time thinking about it. In his session at @ThingsExpo, Ben Klang, Founder & President of Mojo Lingo, discussed the impact of technology on identity. Sho...
Fact is, enterprises have significant legacy voice infrastructure that’s costly to replace with pure IP solutions. How can we bring this analog infrastructure into our shiny new cloud applications? There are proven methods to bind both legacy voice applications and traditional PSTN audio into cloud-based applications and services at a carrier scale. Some of the most successful implementations leverage WebRTC, WebSockets, SIP and other open source technologies. In his session at @ThingsExpo, Da...
A critical component of any IoT project is what to do with all the data being generated. This data needs to be captured, processed, structured, and stored in a way to facilitate different kinds of queries. Traditional data warehouse and analytical systems are mature technologies that can be used to handle certain kinds of queries, but they are not always well suited to many problems, particularly when there is a need for real-time insights.
In his session at DevOps Summit, Tapabrata Pal, Director of Enterprise Architecture at Capital One, will tell a story about how Capital One has embraced Agile and DevOps Security practices across the Enterprise – driven by Enterprise Architecture; bringing in Development, Operations and Information Security organizations together. Capital Ones DevOpsSec practice is based upon three "pillars" – Shift-Left, Automate Everything, Dashboard Everything. Within about three years, from 100% waterfall, C...