Eisai Oncology to Present New Research on Product Portfolio and Pipeline at ASCO Annual Meeting

WOODCLIFF LAKE, N.J., May 17, 2012 /PRNewswire/ -- Eisai announced today that 15 abstracts highlighting new study results will be presented during the 48^th Annual Meeting of the American Society of Clinical Oncology (ASCO), taking place in Chicago from June 1 to June 5, 2012.

These studies highlight Eisai's current product portfolio and oncology pipeline, reinforcing the company's commitment to patients and their families affected by cancer.

"Our human health care mission is to help address unmet medical needs and increase benefits to patients and their families," said Takashi Owa, Ph.D., Chief Scientific Officer, Eisai Product Creation Systems. "Our portfolio of oncology compounds and therapies underscores our commitment to this important mission."

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

The information discussed in this release is about investigational agents that are not Food and Drug Administration (FDA)-approved and investigational uses for FDA-approved products.  It is not intended to convey conclusions of efficacy and safety. There is no guarantee that any of these agents will successfully complete clinical development or gain FDA approval.

HALAVEN® (eribulin mesylate) Injection

Halaven is indicated for the treatment of patients with metastatic breast cancer who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease. Prior therapy should have included an anthracycline and a taxane either in the adjuvant or metastatic setting.

Important Safety Information about HALAVEN®

Decreased White Blood Cells (Neutropenia)

Your doctor should do a blood test to monitor your blood cells before you receive each dose of HALAVEN, and should monitor you more often if you develop lower white blood cells. If you develop severe neutropenia lasting longer than 7 days or neutropenia with a fever, your next dose of HALAVEN should be delayed and reduced. Severe neutropenia occurred in 57% (287/503) of patients who received HALAVEN and lasted more than 1 week in 12% (62/503) of patients. Neutropenia with a fever occurred in 5% (23/503) of patients; 2 patients died from complications of neutropenia with a fever.  Neutropenia with a fever can result in serious infections that could lead to hospitalization or death. Call your healthcare provider immediately if you have any of the following symptoms; fever (temperature above 100.5 degrees F), chills, coughing, burning or pain when you urinate.

Nerve Disorders (Peripheral Neuropathy)

HALAVEN can cause numbness, tingling, or burning in your hands and feet (peripheral neuropathy). You should be monitored closely for signs of neuropathy.  If you develop severe neuropathy, treatment with HALAVEN should be delayed until the neuropathy improves and the next dose of HALAVEN should be reduced. Severe peripheral neuropathy occurred in 8% (42/503) of patients who received HALAVEN. Neuropathy lasting more than one year occurred in 5% of patients. Twenty-two percent (109/503) of patients developed a new or worsening neuropathy that had not recovered after an average of 269 days.  Peripheral neuropathy was the most common side effect that caused patients to stop receiving HALAVEN.

Pregnancy and Nursing

HALAVEN may harm your unborn baby. Avoid becoming pregnant while you are receiving HALAVEN. Tell your healthcare provider right away if you become pregnant or think you are pregnant while you are receiving HALAVEN. You and your healthcare provider should decide if you will receive HALAVEN or breastfeed. You should not do both.

Heartbeat Changes

HALAVEN can cause changes in your heartbeat (called QTc prolongation). This can cause irregular heartbeats that may lead to death. Your healthcare provider will decide if you need heart monitoring (electrocardiogram or ECG), or blood tests during your treatment with HALAVEN to watch for this problem. 

Liver and Kidney Problems

In patients with mild or moderate liver problems, and/or moderate kidney problems, a lower starting dose of HALAVEN is recommended.

Most Common Side Effects

The most common side effects reported in greater than or equal  to 25% of patients receiving HALAVEN were low white blood cells (82%), low red blood cells (58%), weakness/tiredness (54%), hair loss (45%), numbness, tingling or burning in your hands and feet (35%), nausea (35%), and constipation (25%).  The most common serious side effects reported in patients receiving HALAVEN were neutropenia with or without a fever (4% and 2%, respectively).

For full prescribing information for HALAVEN, please visit: http://www.halaven.com/sites/default/files/HALAVEN_full_Prescribing_Information.pdf

DACOGEN^® (decitabine) for Injection

Dacogen is a nucleoside metabolic inhibitor indicated for treatment of patients with myelodysplastic syndromes (MDS) including previously treated and untreated, de novo and secondary MDS of all French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia) and intermediate-1, intermediate- 2, and high-risk International Prognostic Scoring System groups. (1)

Important Safety Information

Treatment with DACOGEN is associated with neutropenia and thrombocytopenia. Complete blood and platelet counts should be performed as needed to monitor response and toxicity but at a minimum prior to each dosing cycle. After administration of the recommended dosage for the first cycle, treatment for subsequent cycles should be adjusted if indicated by dose adjustment guidelines. Clinicians should consider the need for early institution of growth factors and/or antimicrobial agents for the prevention or treatment of infections in patients with MDS.

DACOGEN may cause fetal harm when administered to a pregnant woman. Women of childbearing potential should be advised to avoid becoming pregnant while receiving treatment with DACOGEN and for 1 month following completion of treatment. Women of childbearing potential should be counseled to use effective contraception during this time. Men should be advised not to father a child while receiving treatment with DACOGEN and for 2 months following completion of treatment. DACOGEN may cause fetal harm. Men with female partners of childbearing potential should use effective contraception during this time.

In a phase 3 clinical trial in MDS patients, the highest incidence of Grade 3 or Grade 4 adverse events in the DACOGEN arm was neutropenia (87%), thrombocytopenia (85%), febrile neutropenia (23%), and leukopenia (22%). Bone marrow suppression was the most frequent cause of dose reduction, delay, and discontinuation. Six patients had fatal events associated with their underlying disease and myelosuppression (anemia, neutropenia, and thrombocytopenia) that were considered at least possibly related to drug treatment. Of the 83 DACOGEN-treated patients, 8 permanently discontinued therapy for adverse events compared to 1 of 81 patients in the supportive care arm.

In a single-arm study in MDS patients, the highest incidence of Grade 3 or Grade 4 adverse events was neutropenia (37%), thrombocytopenia (24%), and anemia (22%). Seventy-eight percent of patients had dose delays, the median duration of this delay was 7 days. Hematologic toxicities and infections were the most frequent causes of dose delays and discontinuation. Eight patients had fatal events due to infection and/or bleeding that were considered at least possibly related to drug treatment. Nineteen of 99 patients permanently discontinued therapy for adverse events.

Other commonly occurring reactions include fatigue, pyrexia, nausea, cough, petechiae, constipation, diarrhea, and hyperglycemia.

If hematologic recovery from a previous DACOGEN treatment cycle requires more than 6 weeks when administering the 3-day dosing, then the next DACOGEN cycle should be delayed and dosing temporarily reduced. When administering the 5-day dosing, the DACOGEN cycle should be delayed until there is hematologic recovery. If the following nonhematologic toxicities are present, DACOGEN treatment should not be restarted until the toxicity is resolved: (1) serum creatinine greater than or equal to 2 mg/dL; (2) SGPt, total bilirubin greater than or equal to 2 × ULN; and (3) active or uncontrolled infection.

Because there are no data on use of DACOGEN in patients with renal or hepatic dysfunction, DACOGEN should be used with caution in these patients.

For full prescribing information, please see http://us.eisai.com/pdf_files/Dacogen_PI.pdf.

Eisai Oncology

Eisai Oncology is dedicated to discovering, developing and producing innovative oncology therapies that can help make a difference and impact the lives of patients and their families. This passion for people is part of Eisai's human health care (hhc) mission, which strives for better understanding of the needs of patients and their families to increase the benefits health care provides. Our commitment to meaningful progress in oncology research, built on scientific expertise, is supported by a global capability to conduct discovery and preclinical research, and develop small molecules, biologic and supportive care agents for cancer across multiple indications.

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.

Morphotek

Morphotek^®, Inc., a subsidiary of Eisai Inc., is a biopharmaceutical company specializing in the development of protein and antibody products through the use of a novel and proprietary gene evolution technology.  The technology has been successfully applied to a broad variety of cell lines and organisms to yield genetically diverse offspring that are suitable for pharmaceutical product development in the areas of antibody therapeutics, protein therapeutics, product manufacturing, drug target discovery, and improved output traits for commercial applications.  The company is currently focusing its platform on the development and manufacturing of therapeutic antibodies for the treatment of cancer, inflammation and infectious disease.  For more information, please visit www.morphotek.com

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.

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SOURCE Eisai Inc.