News Feed Item

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 /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. 

(Logo: http://photos.prnewswire.com/prnh/20120413/MM87168LOGO )
(Logo: http://photos.prnewswire.com/prnh/20121217/NY30586LOGO )

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 carmustine implant)

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 implantation.

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 tumor progression.

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):

  • Seizures: 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. 
  • Brain 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.
  • Healing 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. 
  • Intracranial 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.
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 the world.  

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 healthcare system.

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.com or send email inquiries to [email protected].

Eisai Inc.

Arbor Pharmaceuticals

Media Inquiries

Investor Inquiries

Media Inquiries

Investor Inquiries

Lynn Kenney

Alex Scott

Brian Adams

Jason McCarthy

Eisai Inc.

Eisai Inc.

Arbor Pharmaceuticals

Arbor Pharmaceuticals





SOURCE Eisai Inc.

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
The standardization of container runtimes and images has sparked the creation of an almost overwhelming number of new open source projects that build on and otherwise work with these specifications. Of course, there's Kubernetes, which orchestrates and manages collections of containers. It was one of the first and best-known examples of projects that make containers truly useful for production use. However, more recently, the container ecosystem has truly exploded. A service mesh like Istio addr...
As DevOps methodologies expand their reach across the enterprise, organizations face the daunting challenge of adapting related cloud strategies to ensure optimal alignment, from managing complexity to ensuring proper governance. How can culture, automation, legacy apps and even budget be reexamined to enable this ongoing shift within the modern software factory? In her Day 2 Keynote at @DevOpsSummit at 21st Cloud Expo, Aruna Ravichandran, VP, DevOps Solutions Marketing, CA Technologies, was jo...
Predicting the future has never been more challenging - not because of the lack of data but because of the flood of ungoverned and risk laden information. Microsoft states that 2.5 exabytes of data are created every day. Expectations and reliance on data are being pushed to the limits, as demands around hybrid options continue to grow.
Business professionals no longer wonder if they'll migrate to the cloud; it's now a matter of when. The cloud environment has proved to be a major force in transitioning to an agile business model that enables quick decisions and fast implementation that solidify customer relationships. And when the cloud is combined with the power of cognitive computing, it drives innovation and transformation that achieves astounding competitive advantage.
Digital Transformation: Preparing Cloud & IoT Security for the Age of Artificial Intelligence. As automation and artificial intelligence (AI) power solution development and delivery, many businesses need to build backend cloud capabilities. Well-poised organizations, marketing smart devices with AI and BlockChain capabilities prepare to refine compliance and regulatory capabilities in 2018. Volumes of health, financial, technical and privacy data, along with tightening compliance requirements by...
As IoT continues to increase momentum, so does the associated risk. Secure Device Lifecycle Management (DLM) is ranked as one of the most important technology areas of IoT. Driving this trend is the realization that secure support for IoT devices provides companies the ability to deliver high-quality, reliable, secure offerings faster, create new revenue streams, and reduce support costs, all while building a competitive advantage in their markets. In this session, we will use customer use cases...
Evan Kirstel is an internationally recognized thought leader and social media influencer in IoT (#1 in 2017), Cloud, Data Security (2016), Health Tech (#9 in 2017), Digital Health (#6 in 2016), B2B Marketing (#5 in 2015), AI, Smart Home, Digital (2017), IIoT (#1 in 2017) and Telecom/Wireless/5G. His connections are a "Who's Who" in these technologies, He is in the top 10 most mentioned/re-tweeted by CMOs and CIOs (2016) and have been recently named 5th most influential B2B marketeer in the US. H...
The best way to leverage your Cloud Expo presence as a sponsor and exhibitor is to plan your news announcements around our events. The press covering Cloud Expo and @ThingsExpo will have access to these releases and will amplify your news announcements. More than two dozen Cloud companies either set deals at our shows or have announced their mergers and acquisitions at Cloud Expo. Product announcements during our show provide your company with the most reach through our targeted audiences.
DevOpsSummit New York 2018, colocated with CloudEXPO | DXWorldEXPO New York 2018 will be held November 11-13, 2018, in New York City. Digital Transformation (DX) is a major focus with the introduction of DXWorldEXPO within the program. Successful transformation requires a laser focus on being data-driven and on using all the tools available that enable transformation if they plan to survive over the long term. A total of 88% of Fortune 500 companies from a generation ago are now out of bus...
With 10 simultaneous tracks, keynotes, general sessions and targeted breakout classes, @CloudEXPO and DXWorldEXPO are two of the most important technology events of the year. Since its launch over eight years ago, @CloudEXPO and DXWorldEXPO have presented a rock star faculty as well as showcased hundreds of sponsors and exhibitors! In this blog post, we provide 7 tips on how, as part of our world-class faculty, you can deliver one of the most popular sessions at our events. But before reading...
As you move to the cloud, your network should be efficient, secure, and easy to manage. An enterprise adopting a hybrid or public cloud needs systems and tools that provide: Agility: ability to deliver applications and services faster, even in complex hybrid environments Easier manageability: enable reliable connectivity with complete oversight as the data center network evolves Greater efficiency: eliminate wasted effort while reducing errors and optimize asset utilization Security: implemen...
DXWordEXPO New York 2018, colocated with CloudEXPO New York 2018 will be held November 11-13, 2018, in New York City and will bring together Cloud Computing, FinTech and Blockchain, Digital Transformation, Big Data, Internet of Things, DevOps, AI, Machine Learning and WebRTC to one location.
DXWorldEXPO LLC announced today that ICOHOLDER named "Media Sponsor" of Miami Blockchain Event by FinTechEXPO. ICOHOLDER give you detailed information and help the community to invest in the trusty projects. Miami Blockchain Event by FinTechEXPO has opened its Call for Papers. The two-day event will present 20 top Blockchain experts. All speaking inquiries which covers the following information can be submitted by email to [email protected] Miami Blockchain Event by FinTechEXPO also offers s...
DXWorldEXPO | CloudEXPO are the world's most influential, independent events where Cloud Computing was coined and where technology buyers and vendors meet to experience and discuss the big picture of Digital Transformation and all of the strategies, tactics, and tools they need to realize their goals. Sponsors of DXWorldEXPO | CloudEXPO benefit from unmatched branding, profile building and lead generation opportunities.
@DevOpsSummit New York 2018, colocated with CloudEXPO | DXWorldEXPO New York 2018 will be held November 11-13, 2018, in New York City. From showcase success stories from early adopters and web-scale businesses, DevOps is expanding to organizations of all sizes, including the world's largest enterprises - and delivering real results.