Eisai's Commitment to Oncology Demonstrated by Clinical Data to be Presented at ASCO Annual Meeting

WOODCLIFF LAKE, N.J., May 15 /PRNewswire/ -- Eisai Corporation of North America announced today that results from 16 clinical data abstracts about compounds in the company's oncology pipeline, product portfolio and preclinical oncology research have been accepted for presentation at the 44th Annual Meeting of the American Society of Clinical Oncology (ASCO), taking place in Chicago from May 30 to June 3, 2008.

A wide variety of abstracts on Eisai marketed products and investigational compounds will showcase research focused on metastatic breast cancer, lung cancer, ovarian cancer, brain cancer, mesothelioma, pancreatic cancer, myelodysplastic syndromes and other types of cancer, as well as supportive care to aid those currently undergoing treatment for cancer.

"Eisai's commitment to oncology is clearly translating into the substantial growth of our pipeline," said Haruo Naito, President and CEO, Eisai Co., Ltd. "Eisai's focus on becoming a global leader in oncology reflects our human health care mission to satisfy unmet medical needs and increase benefits to patients and their families."

The following Eisai abstracts are accepted for presentation at this year's ASCO meeting.

Product Abstract Details Location Details

MORAb-003 Exploratory Phase II Efficacy June 1, 2008
(farletuzumab) Study of MORAb-003, a Monoclonal 4:30-4:45 p.m.
Abstract No: 5500 Antibody against Folate Receptor Location: S406
Alpha, in Platinum-Sensitive (Vista Room)
Ovarian Cancer in First Relapse
Oral Presentation

E7080 A phase I study of E7080 in May 31, 2008
Abstract No: 3526 patients with advanced 8:00 a.m.
malignancies -12:00 p.m.
Location: W375E
Lobby

Poster 3 Poster
Awarded a Foundation Merit Award discussion
12:00-1:00 p.m.
Location: W375A

E7080 Phase I dose escalation study May 31, 2008
Abstract No: 3527 and biomarker analysis of 8:00 a.m.
E7080 in patients with -12:00 p.m.
advanced solid tumors Location: W375E
Poster 4 Lobby
Poster
discussion
12:00-1:00 p.m.
Location: W375A

Cutaneous T-cell (Integrated analysis of three May 31, 2008
Lymphoma large Phase III trials in CTCL) 8:00 a.m.
Abstract No: 8551 Poster 45A -12:00 p.m.
Location: S Hall
A1

MORAb-003 A Phase I Study of MORAb-003, May 31, 2008
(farletuzumab) a Humanized Monoclonal Antibody 2:00-6:00 p.m.
Abstract No: 5517 Against Folate Receptor Alpha, Location: S403
in Advanced Epithelial Poster
Ovarian Cancer discussion
Poster 7 5:00-6:00 p.m.
Location: S406
(Vista Room)

ALOXI(R) Palonosetron (PALO) for May 31, 2008
(palonosetron HCl) Prevention of Chemotherapy- 2:00-6:00 p.m.
Abstract No: 9617 induced Nausea and Vomiting Location: S Hall
in Patients Receiving High- A1
dose Melphalan Prior to
Stem Cell Transplant
Poster 46B

GCP II Inhibitor Glutamate Carboxypeptidase II May 31, 2008
Abstract No: 9558 Inhibition in Rat Models of 2:00-6:00 p.m.
Chemotherapy-induced Location: S Hall
Peripheral Neurotoxicity A1
Poster 37A

E7820 A phase I study of E7820 in June 1, 2008
Abstract No: 3568 combination with cetuximab in 2:00-6:00 p.m.
patients (pts) with advanced Location: S Hall
solid tumors A1
Poster 24G

MORAb-009 A Phase I Study of MORAb-009, June 1, 2008
Abstract No: 3578 a Monoclonal Antibody against 2:00-6:00 p.m.
Mesothelin, in Mesothelioma, Location: S Hall
Pancreatic, and Ovarian Cancer A1
Poster 27C

Eribulin Phase II Study of Eribulin June 2, 2008
Mesylate (E7389) Mesylate (E7389) in Patients 2:00-6:00 p.m.
Abstract No: 1084 with Locally Advanced or Location: S Hall
Metastatic Breast Cancer A1
Previously Treated with
Anthracycline, Taxane, and
Capecitabine Therapy
Poster 38A

Advanced Breast Oncologist and Patient Roles in June 2, 2008
Cancer Assessing Current and Future 2:00-6:00 p.m.
Abstract No: 1064 Treatment for Metastatic Location: S Hall
Breast Cancer: Results of an A1
Observational Linguistic study
Poster 32B

DACOGEN(R) A Multicenter Phase II Trial of June 2, 2008
(decitabine) the Decitabine Alternative 2:00-6:00 p.m.
Abstract No: 7032 5-day Dosing Regimen: Analysis Location: E450A
of Efficacy in Various
Subgroups of Patients with Poster
Myelodysplastic Syndromes discussion
Poster 21 5:00-6:00 p.m.
Location: E354A

DACOGEN(R) Cytogenetic Responses to a June 2, 2008
(decitabine) 5-Day Dosing Schedule of 2:00-6:00 p.m.
Abstract No: 7030 Decitabine in Patients with Location: E450A
Myelodysplastic Syndromes
Poster 19 Poster
discussion
5:00-6:00 p.m.
Location: E354A

ALOXI(R) Palonosetron (PALO) versus Accepted for
(palonosetron granisetron (GRAN), both publication
HCl) combined with dexamethasone only.
(DEX) in preventing
chemotherapy-induced nausea
and vomiting (CINV) associated
with cisplatin- or anthracycline
plus cyclophosphamide-based
regimens: Results of a Phase III
trial in Japanese patients

ALOXI(R) Palonosetron (PALO), administered Accepted for
(palonosetron orally or intravenously (IV), publication
HCl) plus dexamethasone for prevention only.
of chemotherapy-induced nausea
and vomiting (CINV)

GLIADEL(R) Wafer Treatment of Adults with Newly Accepted for
(polifeprosan 20 Diagnosed Glioblastoma publication
with carmustine Multiforme or Anaplastic only.
implant) Astrocytoma with Surgery, Gliadel
Wafers and Limited Field
Radiation Plus Concomitant
Temozolomide Followed by
Adjuvant Temozolomide

Eisai began its oncology research program in 1987, discovering several small molecules that are in development as chemotherapeutic agents. In addition to its in-house oncology research and development (R&D) program, Eisai made three strategic acquisitions to establish a solid business infrastructure and enter the U.S. oncology market.

In October 2006, Eisai acquired four products mainly for the treatment of cutaneous T-cell lymphoma, as well as an oncology specialty sales force from Ligand Pharmaceuticals. This provided Eisai with an initial commercial infrastructure for oncology products. The acquisition of Morphotek, Inc. in April 2007 added important antibody technology and an antibody pipeline. In January 2008, Eisai acquired MGI PHARMA, INC., an oncology and acute care-focused company, to broaden its R&D and commercial capabilities, pipeline and product portfolio in oncology and supportive care.

Eisai is committed to addressing the unmet medical needs of patients with cancer and to delivering novel treatment options that create hope.

About Aloxi Injection

Aloxi is approved by the U.S. FDA for the prevention of acute nausea and vomiting associated with initial and repeat courses of moderately and highly emetogenic cancer chemotherapy and for the prevention of delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy. Aloxi is the first and only 5-HT(3) receptor antagonist to be indicated for the prevention of delayed CINV caused by moderately emetogenic cancer chemotherapy.

The most common adverse reactions related to Aloxi were headache (9%) and constipation (5%). Aloxi is contraindicated in patients known to have hypersensitivity to the drug or any of its components.

Please see the Aloxi package insert, available at www.aloxi.com, for important additional details.

About Gliadel Wafer

Gliadel (polifeprosan 20 with carmustine implant) Wafer is indicated in patients with newly diagnosed high-grade malignant glioma as an adjunct to surgery and radiation. Gliadel is also indicated in patients with recurrent glioblastoma multiforme as an adjunct to surgery.

Gliadel should not be given to individuals who have demonstrated a previous hypersensitivity to carmustine or any of the components of Gliadel. Patients undergoing craniotomy for malignant glioma and implantation of Gliadel should be monitored closely for complications of craniotomy, including seizures, intracranial infections, abnormal wound healing and brain edema.

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. Computed tomography and magnetic resonance imaging of the head may demonstrate enhancement in the brain tissue surrounding the resection cavity after implantation of Gliadel. This enhancement may represent edema and inflammation caused by Gliadel or tumor progression. The short-term and long- term toxicity profiles of Gliadel, when given in conjunction with chemotherapy have not been fully explored.

Please visit www.mgipharma.com or
About Dacogen

Dacogen (decitabine) for Injection was approved by the U.S. Food and Drug Administration on May 2, 2006 and is indicated for treatment of patients with myelodysplastic syndromes (MDS) including previously treated and untreated, de novo and secondary MDS of all French-American-British (FAB) subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, chronic myelomonocytic leukemia), and Intermediate-1, Intermediate-2 and High-Risk International Prognostic Scoring System (IPSS) groups.

Dacogen may cause fetal harm when administered to a pregnant woman. Women of childbearing potential should be advised to avoid becoming pregnant while using Dacogen. Men should be advised not to father a child while receiving treatment with Dacogen and for two months afterwards. The most commonly occurring adverse reactions with Dacogen include neutropenia (90%), thrombocytopenia (89%), anemia (82%), pyrexia (53%), fatigue (48%), nausea (42%), cough (40%), petechiae (39%), constipation (35%), and diarrhea (34%).

Please visit www.mgipharma.com or
About Eisai Corporation of North America

Eisai Corporation of North America is a wholly-owned subsidiary of Eisai Co., Ltd., 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: neurology, gastrointestinal disorders and oncology/critical care.

Eisai Corporation of North America supports the activities of its operating companies in North America, which include: Eisai Research Institute of Boston, Inc., a discovery operation with strong organic chemistry capabilities; Morphotek, Inc., a biopharmaceutical company specializing in the development of therapeutic monoclonal antibodies; Eisai Medical Research Inc., a clinical development group; Eisai Inc., a commercial operation with manufacturing and marketing/sales functions; MGI PHARMA, INC., an R&D and commercial operation with manufacturing and marketing/sales functions; and Eisai Machinery U.S.A., which markets and maintains pharmaceutical manufacturing machinery.

First Call Analyst:
FCMN Contact:

Source: Eisai Corporation of North America

CONTACT: Judee Shuler, Eisai Corporation of North America, During ASCO:
+1-908-337-2540, Office: +1-201-746-2241

Web site: http://www.aloxi.com/
http://www.gliadel.com/
http://www.mgipharma.com/
http://www.dacogen.com/

2008-05-15 22:10:24 0363618 PRNEWSWIRE