Eisai Highlights New Research at 50th ASCO Annual Meeting

May 14, 2014

Data underscore breadth of oncology portfolio

WOODCLIFF LAKE, N.J., May 14, 2014 /PRNewswire/ — Eisai Inc. announced today that 10 abstracts highlighting new study results will be presented during the 50th Annual Meeting of the American Society of Clinical Oncology (ASCO), taking place in Chicago from May 30 to June 3, 2014.

“Anchored by our human health care mission, Eisai’s commitment to cancer patients and their families is evidenced by our focus on sometimes overlooked patient populations and our investment in the development of treatment options that have the potential to impact these communities,” said Kenichi Nomoto, Ph.D., President, Oncology Product Creation Unit at Eisai Inc. “Oncology is a key franchise area for our company with a diverse portfolio of treatments and supportive care agents. The studies being presented at this year’s ASCO Annual Meeting reflect our hhc mission and commitment to providing options for cancer patients in need, whether those needs affect a few patients or many.”

Of note, the results of a Phase III study with lenvatinib, an investigational agent being evaluated for radioiodine-refractory differentiated thyroid cancer (RR-DTC), will be included in the ASCO press conference on Saturday, May 31. The data will also be presented in an oral session on Monday, June 2, 2014.

Additional presentations will include results from the continued study of Halaven(®) (eribulin mesylate) for investigational uses in both early and late-stage breast cancer and a Phase III study with NEPA, an investigational oral fixed-dose combination of netupitant and palonosetron, in the prevention of chemotherapy-induced nausea and vomiting.

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

    Product              Abstract Name
    -------              -------------

    Lenvatinib            A phase III, multicenter, double-blind,
                          placebo-controlled trial of lenvatinib
                          (E7080) in patients with 131I-refractory
                          differentiated thyroid cancer (SELECT).

    (E7080)              Oral Presentation

    Abstract No: LBA6008

                          Prognostic and predictive role of
                          circulating angiopoietin-2 in multiple
                          solid tumors: An analysis of approximately
                          500 patients treated with lenvatinib across
    Lenvatinib            tumor types.

    (E7080)              Poster Presentation

    Abstract No: 11061

                          A multicenter, open-label, phase 3 trial to
                          compare the efficacy and safety of
                          lenvatinib (E7080) versus sorafenib in
                          first-line treatment of subjects with
    Lenvatinib            unresectable hepatocellular carcinoma.

    (E7080)              Poster Presentation

    Abstract No: TPS4153

    Lenvatinib            E7080 (lenvatinib) in addition to best
                          supportive care (BSC) versus BSC alone in
                          third-line or greater non-squamous, non-
                          small cell lung cancer (NSCLC).

    (E7080)              Poster Presentation

    Abstract No: 8043

                          Phase 3 study of NEPA, a fixed-dose
                          combination of netupitant and palonosetron,
                          for prevention of chemotherapy-induced
                          nausea and vomiting during repeated
                          moderately emetogenic chemotherapy (MEC)
    NEPA                  cycles.

    Abstract No: 9502    Oral Presentation
    -----------------    -----------------

    Eribulin Mesylate     Pharmacokinetics (PK) of eribulin mesylate
                          in cancer patients with normal and impaired
                          renal function.

    (Halaven(R))         Poster Presentation

    Abstract No: 2595

    Eribulin Mesylate     Efficacy of eribulin in patients with
                          metastatic breast cancer (MBC): a pooled
                          analysis by HER2 and ER status.

    (Halaven(R))         Poster Presentation

    Abstract No: 631

                          Clinical effects of prior anthracycline or
                          taxane use on eribulin as first-line
                          treatment for HER+/- locally recurrent or
                          metastatic breast cancer (BC): results from
                          2 Phase 2, multicenter, single-arm
    Eribulin Mesylate     studies.

    (Halaven(R))         Poster Presentation

    Abstract No: 629

                          Clinical effects of prior trastuzumab on
                          combination eribulin mesylate + trastuzumab
                          as first-line treatment for HER2+ locally
                          recurrent or metastatic breast cancer
                          (MBC): results from a phase 2, single-arm,
    Eribulin Mesylate     multicenter study.

    (Halaven(R))         Poster Presentation

    Abstract No: 635

                          Phase 2 feasibility study of dose-dense
                          doxorubicin and cyclophosphamide (AC)
                          followed by eribulin mesylate with or
                          without prophylactic growth factor (GF) for
                          adjuvant treatment of early-stage breast
    Eribulin Mesylate     cancer (EBC)

    (Halaven(R))         Poster Presentation

    Abstract No: TPS670

The information discussed in this release presents 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 about efficacy and safety. There is no guarantee that any of these investigational agents or investigational uses of FDA-approved products will successfully complete clinical development or gain FDA approval.

About Lenvatinib (E7080)

Lenvatinib, discovered and developed by Eisai, is an oral inhibitor of select receptor tyrosine kinases (RTKs) including VEGFR 1-3, FGFR 1-4, PDGFR-beta, KIT and RET involved in angiogenesis and tumor proliferation. It is currently under development for thyroid, hepatocellular, endometrial and other solid tumor types. Lenvatinib was granted Orphan Drug Designation (ODD) in Japan for thyroid cancer in August 2012, in the United States for follicular, medullary, anaplastic, and metastatic or locally advanced papillary thyroid cancer in December 2012, and in Europe for follicular and papillary thyroid cancer in April 2013.

About HALAVEN® (eribulin mesylate) Injection

Eribulin mesylate injection (known as Halaven(®))( )is a non-taxane, microtubule dynamics inhibitor that is a synthetic analog of halichondrin B, a natural product that was isolated from the marine sponge Halichondria okadai. Halaven( )is indicated for patients with metastatic breast cancer who have received at least two other types of anticancer medicines for their breast cancer. Previous therapy should have included an anthracycline and a taxane for either early or advanced breast cancer.

The FDA approval of Halaven in November 2010 was supported by results from EMBRACE, a phase III, randomized (2:1), open-label, multicenter, multinational trial in patients with metastatic breast cancer.

Important Safety Information

    --  Decreased White Blood Cells (Neutropenia)
        --  Doctors should do blood tests to monitor patients' blood cells
            before they receive each dose of HALAVEN, and should monitor them
            more often if they develop lower white blood cells.
        --  If patients develop severe neutropenia lasting longer than 7 days or
            neutropenia with a fever, their next dose of HALAVEN should be
            delayed and reduced. Severe neutropenia occurred in 57% of patients
            who received HALAVEN and lasted more than 1 week in 12% of patients.
        --  Neutropenia with a fever occurred in 5% 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. Patients should call their
            healthcare providers immediately if they have any of the following
            symptoms: fever (temperature above 100.5 degrees F), chills,
            coughing, burning or pain when they urinate.
    --  Nerve Disorders (Peripheral Neuropathy)
        --  HALAVEN can cause numbness, tingling, or burning in a patient's
            hands and feet (peripheral neuropathy). Patients should be monitored
            closely for signs of neuropathy. If they 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% of patients who received
            HALAVEN. Neuropathy lasting more than one year occurred in 5% of
            patients. 22% 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 a patient's unborn baby. Patients must avoid
            becoming pregnant while they are receiving HALAVEN. They should tell
            their healthcare providers right away if they become pregnant or
            think they are pregnant while they are receiving HALAVEN.
        --  Patients and their healthcare providers should decide if they will
            receive HALAVEN or breastfeed. They should not do both.
    --  Heartbeat Changes
        --  HALAVEN can cause changes in a patient's heartbeat (called QTc
            prolongation). This can cause irregular heartbeats that may lead to
        --  Healthcare providers will decide if patients need heart monitoring
            (electrocardiogram or ECG), or blood tests during their 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 >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
        --  The most common serious side effects reported in patients receiving
            HALAVEN were neutropenia with or without a fever (4% and 2%,

Please see the HALAVEN full prescribing information.

About Netupitant 300 mg + Palonosetron 0.50 mg (NEPA)

NEPA is an investigational oral, fixed-dose combination of a selective NK(1 )receptor antagonist, netupitant, and a 5-HT(3) receptor antagonist, palonosetron, believed to target two critical pathways associated with chemotherapy-induced nausea and vomiting (CINV).

On December 9, 2013, the U.S. Food and Drug Administration (FDA) accepted for review the submission of Helsinn’s New Drug Application (NDA) for NEPA for the prevention of acute and delayed chemotherapy-induced nausea and vomiting (CINV). Acceptance of the NDA indicates that the FDA has found the submission to be sufficiently complete to review.

On January 22, 2014, the European Medicines Agency (EMA) accepted for review the submission of Helsinn’s Marketing Authorisation Application for the prevention of acute and delayed CINV. Acceptance of the MAA indicates that the EMA has found the submission to be valid for review.

About Helsinn and Eisai

Helsinn signed a licensing agreement with Eisai Inc. granting Eisai commercial rights for NEPA in the United States (if approved). Under the terms of the agreement, Helsinn is responsible for conducting all development activities (Chemistry and Manufacturing Controls [CMC], preclinical and clinical), obtaining regulatory approvals and holding the New Drug Application (NDA). If approved by the FDA, NEPA will be co-promoted in the United States by Eisai Inc. and Helsinn Therapeutics U.S. Inc., the U.S. company of the Swiss group.

About the Helsinn Group

Helsinn is a family run, privately owned pharmaceutical group focused on building quality cancer care with a large portfolio of products. Founded in 1976 with headquarters in Lugano, Switzerland, Helsinn also has operating subsidiaries in Ireland, the U.S. and a Representative Office in China. Helsinn’s business model is focused on the licensing of pharmaceuticals, medical devices and nutritional supplement products in the therapeutic area of cancer care.

Helsinn Group in-licenses early-to-late stage new chemical entities, completing their development by performing preclinical and clinical studies and associated manufacturing activities. Helsinn then prepares necessary regulatory filings in order to achieve marketing approvals worldwide. Helsinn’s products are out-licensed to its global network of marketing and commercial partners that have been selected for their local market knowledge. Helsinn supports these partners by providing a full range of product and scientific management services, including commercial, regulatory, and medical marketing advice. In March 2013, Helsinn established a new commercial organization within its subsidiary, Helsinn Therapeutics (U.S.), Inc., in order to conduct direct sales and marketing activities within the U.S. market. Helsinn’s products are manufactured according to the highest quality, safety, and environmental standards at Helsinn’s GMP facilities in Switzerland and Ireland from where they are then supplied worldwide to customers. Further information on Helsinn Group is available at www.helsinn.com.

About Eisai Oncology

Eisai Oncology is dedicated to discovering, developing and producing innovative oncology therapies that may 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 help 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, vaccines, and biologic agents across various types of cancer. For more information about Eisai, please visit www.eisai.com/US.

About Eisai Inc.

At Eisai Inc., human health care is our goal. We give our first thoughts to patients and their families, and helping to increase the benefits health care provides. As the U.S. pharmaceutical subsidiary of Tokyo-based Eisai Co., Ltd., we have a passionate commitment to patient care that is the driving force behind our efforts to help address unmet medical needs. We are a fully integrated pharmaceutical business with discovery, clinical, manufacturing and marketing capabilities. Our key areas of commercial focus include oncology and specialty care (Alzheimer’s disease, epilepsy and metabolic disorders). To learn more about Eisai Inc., please visit us at www.eisai.com/US.

Eisai Inc. has affiliates that are part of a global product creation organization that includes R&D facilities in Massachusetts, New Jersey, North Carolina and Pennsylvania, as well as a global demand chain organization that includes manufacturing facilities in Maryland and North Carolina. Eisai’s global areas of R&D focus include neuroscience; oncology; metabolic disorders; vascular, inflammatory and immunological reaction; and antibody-based programs.

    Contacts:                     Media                 Investors

                                  Lisa Wolfe            Alex Scott

                                  Eisai Inc.            Eisai Inc.

                                  201-746-2959          201-746-2177

SOURCE Eisai Inc.

Source: PR Newswire

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