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    Genentech Releases Phase III Efficacy Results of OCREVUS™

    Chelsea Pratt
    Sep. 14, 2016 01:27AM PST
    Pharmaceutical Investing

    Genentech, a member of the Roche group, today announced new analyses from the three OCREVUS™ (ocrelizumab) Phase III studies in relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS) will be presented during the 32nd congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), from September 14-17 in London, England.

    SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche group (SIX: RO, ROG; OTCQX: RHHBY), today announced new analyses from the three OCREVUS™ (ocrelizumab) Phase III studies in relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS) will be presented during the 32nd congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), from September 14-17 in London, England.
    OCREVUS increased disease control in patients with RMS and PPMS in
    separate post-hoc analyses. In these analyses, two composite endpoints
    measured disease control using a combination of clinical and MRI
    outcomes: No Evidence of Disease Activity (NEDA) in patients with RMS
    and No Evidence of Progression (NEP) in patients with PPMS. These
    composite endpoints are emerging as new treatment targets.
    A NEDA analysis of pooled data from the Phase III OPERA I and OPERA II
    studies compared no evidence of disease activity during different time
    periods over two years of study. NEDA is achieved when a patient has no
    relapses, no confirmed disability progression, no gadolinium-enhancing
    MRI lesions and no new or enlarging MRI lesions. The data showed that
    OCREVUS significantly increased the proportion of RMS patients achieving
    NEDA by 75 percent compared with interferon beta-1a over 96 weeks (0-96
    weeks, p<0.0001). Additionally, compared with interferon beta-1a,
    OCREVUS treatment significantly increased the relative proportion of
    patients achieving NEDA by 33 percent in weeks 0-24 and by 72 percent in
    weeks 24-96 (both p<0.0001). A majority of patients achieved NEDA in the
    first 24 weeks of OCREVUS treatment (60.8 percent) and this proportion
    increased during weeks 24-96 of the study (72.2 percent).
    “Controlling clinical and sub-clinical disease activity as early as
    possible is an important treatment goal for people living with MS,” said
    Professor Gavin Giovannoni, Scientific Steering Committee Member of the
    OPERA I and II studies and Chair of Neurology at Barts and The London
    School of Medicine and Dentistry. “These new data suggest that
    ocrelizumab consistently impacts disease progression and has the
    potential to change how we approach treating both relapsing and primary
    progressive MS.”
    New post-hoc analyses of the ORATORIO study in PPMS patients measured
    NEP, which includes three measures of physical disability (confirmed
    disability progression, walking speed and upper extremity function) and
    reflects no evidence of worsening of a person’s physical disability.
    Patients who achieved NEP had no evidence of confirmed disability
    progression sustained for at least 12 weeks and less than 20 percent
    worsening of performance on the timed 25-foot walk and 9-hole peg test.
    OCREVUS treatment significantly increased the proportion of PPMS
    patients with NEP by 47 percent at week 120 compared with placebo
    (p=0.0006).
    “With no approved treatment options, primary progressive MS remains a
    challenge for physicians and people with MS,” said Xavier Montalban,
    M.D., Ph.D., Professor of Neurology and Neuroimmunology at Vall d’Hebron
    University Hospital, Research Institute and Cemcat, Barcelona, Spain.
    “OCREVUS significantly impacted three key disability measurements, which
    further highlight its clinical significance in people with primary
    progressive MS.”
    In addition, new patient-reported outcomes data from the ORATORIO study
    highlighting the unmet need of people with PPMS, including the effect
    OCREVUS had on fatigue measures, will be presented.
    Leading investigators will present the following oral and poster
    presentations:

    Abstract Title

    Abstract Number (type),
    Presentation Date, Time

    An exploratory analysis of 12- and 24-week composite confirmed
    disability progression in patients with primary progressive multiple
    sclerosis in the ORATORIO trial
    P746 (poster), Thursday, September 15, 3:45 – 5:00 p.m. BST
    Infusion-related reactions with ocrelizumab in relapsing multiple
    sclerosis and primary progressive multiple sclerosis
    P720 (poster), Thursday, September 15, 3:45 – 5:00 p.m. BST
    Evaluation of no evidence of progression using composite disability
    outcome measures, in patients with primary progressive multiple
    sclerosis in the ORATORIO trial
    167 (oral), Friday, September 16, 9:51 – 10:03 a.m. BST
    Effect of ocrelizumab on magnetic resonance imaging markers of
    neurodegeneration in patients with relapsing multiple sclerosis:
    analysis of the Phase III, double-blind, double-dummy, interferon
    beta-1a-controlled OPERA I and OPERA II studies
    P1011 (poster), Friday, September 16, 3:30 – 5:00 p.m. BST
    Patient-reported outcomes in the Phase III double-blind,
    placebo-controlled ORATORIO study of ocrelizumab in primary
    progressive multiple sclerosis
    P1279 (poster), Friday, September 16, 3:30 – 5:00 p.m. BST
    Infections and serious infections with ocrelizumab in relapsing
    multiple sclerosis and primary progressive multiple sclerosis
    P1248 (poster), Friday, September 16, 3:30 – 5:00 p.m. BST
    Design of two phase III open-label trials evaluating ocrelizumab in
    patients with relapsing-remitting multiple sclerosis and suboptimal
    response to disease-modifying treatment
    P1180 (poster), Friday, September 16, 3:30 – 5:00 p.m. BST
    Baseline assessment of fatigue and health-related quality of life in
    patients with primary progressive multiple sclerosis in the ORATORIO
    study
    P1278 (poster), Friday, September 16, 3:30 – 5:00 p.m. BST
    Exploration and verification of a patient-powered research network
    to provide patient insights in multiple sclerosis
    P889 (poster), Friday, September 16, 3:30 – 5:00 p.m. BST
    NEDA epoch analysis of patients with relapsing multiple sclerosis
    treated with ocrelizumab: Results from OPERA I and OPERA II, Phase
    III studies
    P1593 (poster), Friday, September 16, 3:30 – 5:00 p.m. BST
    Real-world treatment observation in multiple sclerosis: development
    of an online platform to measure patients’ treatment awareness and
    experiences, access barriers and decision-making
    ePoster will be displayed on terminals during the congress

    Follow Genentech on Twitter via @Genentech and keep up to date with
    ECTRIMS 2016 news and updates by using the hashtag #ECTRIMS2016.
    As previously announced, the U.S. Food and Drug Administration (FDA)
    accepted for review the company’s Biologics License Application (BLA)
    for OCREVUS for the treatment of RMS and PPMS, and granted the
    application Priority Review Designation with a targeted action date of
    December 28, 2016.
    OCREVUS™ is the proprietary name submitted to the FDA for the
    investigational medicine ocrelizumab.
    About OCREVUS™ (ocrelizumab)
    OCREVUS is an investigational, humanized monoclonal antibody designed to
    selectively target CD20-positive B cells, a specific type of immune cell
    thought to be a key contributor to myelin (nerve cell insulation and
    support) and axonal (nerve cell) damage. This nerve cell damage can lead
    to disability in people with MS. Based on preclinical studies, OCREVUS
    binds to CD20 cell surface proteins expressed on certain B cells, but
    not on stem cells or plasma cells, and therefore important functions of
    the immune system may be preserved.
    The Phase III clinical development program for OCREVUS (ORCHESTRA)
    includes three studies: OPERA I, OPERA II and ORATORIO. OPERA I and
    OPERA II are identical Phase III, randomized, double-blind,
    double-dummy, global multi-center studies that evaluated the efficacy
    and safety of OCREVUS (600 mg administered by intravenous infusion every
    six months) compared with interferon beta-1a (44 mcg administered by
    subcutaneous injection three times per week) in 1,656 people with
    relapsing forms of MS (i.e., relapsing-remitting MS and
    secondary-progressive MS with relapses). ORATORIO is a Phase III,
    randomized, double-blind, global multi-center study that evaluated the
    efficacy and safety of OCREVUS (600 mg administered by intravenous
    infusion every six months) compared with placebo in 732 people with
    primary progressive MS (PPMS).
    The most common adverse events associated with OCREVUS were
    infusion-related reactions and infections, which were mostly mild to
    moderate in severity.
    About multiple sclerosis
    Multiple sclerosis (MS) is a chronic disease that affects an estimated
    2.3 million people around the world, for which there is currently no
    cure. MS occurs when the immune system abnormally attacks the insulation
    and support around nerve cells (myelin sheath) in the brain, spinal cord
    and optic nerves, causing inflammation and consequent damage. This
    damage can cause a wide range of symptoms, including muscle weakness,
    fatigue and difficulty seeing, and may eventually lead to disability.
    Most people with MS experience their first symptom between 20 and 40
    years of age, making the disease the leading cause of non-traumatic
    disability in younger adults.
    Relapsing MS is the most common form of the disease. Disease activity
    and progression can occur even when people do not show signs or symptoms
    of MS, despite available relapsing MS treatments. Primary progressive MS
    (PPMS) is a debilitating form of the disease marked by steadily
    worsening symptoms but typically without distinct relapses or periods of
    remission. Approximately one in 10 people with MS are diagnosed with the
    primary progressive form of the disease. There are no approved
    treatments for PPMS.
    About Genentech in neuroscience
    Neuroscience is a major focus of research and development at Genentech
    and Roche. The company’s goal is to develop treatment options based on
    the biology of the nervous system to help improve the lives of people
    with chronic and potentially devastating diseases. Roche has more than a
    dozen investigational medicines in clinical development for diseases
    that include multiple sclerosis, Alzheimer’s disease, spinal muscular
    atrophy, Parkinson’s disease and autism.
    About Genentech
    Founded 40 years ago, Genentech is a leading biotechnology company that
    discovers, develops, manufactures and commercializes medicines to treat
    patients with serious or life-threatening medical conditions. The
    company, a member of the Roche Group, has headquarters in South San
    Francisco, California. For additional information about the company,
    please visit https://www.gene.com.
    All trademarks used or mentioned in this release are protected by
    law. Rebif is a registered trademark of Merck KGaA and EMD Serono, Inc.

    food and drug administrationdrug candidateclinical trial results
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