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Eisai Inc. (ESALF.PK) Divests U.S. Rights for GLIADEL® Wafer (Polifeprosan 20 With Carmustine Implant) to Arbor Pharmaceuticals



12/17/2012 9:12:38 AM

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 witoh,h 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 Wafertreated 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 info@arborpharma.com.

Eisai Inc.


Arbor Pharmaceuticals


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