Otifex   Therapeutics,   an   emerging   Australian   specialty  pharmaceutical      company    developing    a    new    treatment     for    the    most     common    cause    of   acquired  hearing         loss       in       childhood,       Otitis       Media      with       Effusion       (OME       or       ‘glue       ear’),       has   successfully  completed    the    first    stage    of    its    clinical    development    programme.

The     Phase     1a     study,      conducted     at    two     clinical     sites     in     Australia,      was     a      randomised,     placebo-­‐ controlled,     double-­‐blind,      ‘Single    Ascending      Dose’    clinical    trial    in    healthy    male    and    female    adult    volunteers,     to   examine   safety,   tolerability   and   drug   distribution   characteristics.        In   this   first     stage    of      the    clinical    trials    process,     volunteers    receive    a    single    nasal    spray    dose,    and    once    safety    was    established,    doses    were    increased    in    subsequent    groups    of    volunteers.

The    novel    betahistine    nasal    spray    was    shown    to    be    safe    and    well    tolerated    as    a    single    dose    in healthy  adult    volunteers    at    all    the    doses    tested.

“We  are    very    pleased    with    the    performance    of    our    betahistine    nasal    spray    in    our    first    clinical    trial,” said  Otifex    CEO    Dr    Christopher    Wraight.        “While    betahistine    tablets    have    been    safely    used    by    over 130   million   people   worldwide,   it     was   important     to   demonstrate   the   safety   and   tolerability   of   this    novel     form   of   the   drug   for   a    new   disease   indication.         Our   goal   is   to   develop   a    safe,   easy-­‐to-­‐use    alternative     treatment     to   surgery   for   the   many   children   suffering   from   OME-­‐related     hearing   loss.        We    are    now    one    step    closer    to    realising    this    goal.”

OME  is    common.        In    the    United    States    for    example,    it    affects    around    5    million    young    children    per    year.        Many    (more    than    500,000)    are    treated    surgically    with    the    insertion    of    tympanostomy    tubes,    or    ‘grommets’,    following    a    ‘watchful    waiting’    period    when    the    treating    physician    assesses    whether    middle      ear    fluid    shows    any    signs    of    clearing    naturally.          There    are    no    treatments    available    that    improve    this    clearance    rate,    and    so    Otifex’s    strategy    is    to    address    this    unmet    need.

Based  on    promising    preliminary    animal    data    from    the    University    of    Melbourne,    and    a    product    and    clinical    strategy    developed    in    collaboration    with    the    Murdoch    Childrens    Research    Institute,    Otifex    was    established    in    2009    to    develop    a    betahistine-­‐based    product    suitable    for    use    in    small    children.        The    Otifex    product    is    designed    to    improve    hearing    at    a   critical    time    in    childhood    development,    and    to    reduce    the    need    for    surgical    intervention.

The       Company       estimates       the       market       for       the       Otifex       product       in       OME       is       up       to       $1.2b       in       the    United    States     alone.        Otifex   has   patents   covering   the   use   of   its   betahistine   nasal   spray   product,    granted    in    the    United    States,    Europe,    China,    Japan,    and    in    other    major    markets.

The  Company    is    now    preparing    for    the    next    stage    of    its    clinical    programme,    a    Phase    1b    study    in    a patient    population    to    address    repeat    dose    safety,    tolerability    and    efficacy.


About       Otifex

Otifex       Therapeutics       Pty       Ltd       (www.otifex.com)       is       an       emerging       Australian  specialty       pharmaceutical   company  developing    a    new    treatment    for    the    most    common    cause    of    acquired    hearing    loss    in    childhood,    Otitis    Media    with    Effusion    (OME    or    “glue    ear”).        Treating    OME    often    means    surgically    inserting    “grommets”    (tympanostomy    tubes)    to    help    return    middle    ear    pressure    to    normal;    there    are    currently    no    non-­‐invasive    alternatives.        Otifex    is    developing    a    novel    nasal    spray    to    make    it    easier    for    the    ears    to ‘pop’,     improving   middle   ear   pressure     and   helping     OME   resolve     naturally.        Our   product   has   the   potential   to   be   the   first   effective    non-­‐surgical      treatment    for    OME.          Otifex    was    spun    out    from    The    University    of    Melbourne    in    2009.          In    late    2010    the    Company    attracted    seed    investment    funding    from    the    Medical    Research    Commercialisation    Fund    (MRCF)    and    Uniseed.        Otifex    formulated    its    clinical    development    strategy    in    collaboration    with    MRCF    member    the    Murdoch    Childrens    Research    Institute    (MCRI).

Dr  Christopher    Wraight, Chief  Executive    Officer
Office:     +61    3   9657    0700
Mobile/cell:     +61    438    544    321


About    the    Medical    Research    Commercialisation    Fund

The   $51     million   Medical   Research   Commercialisation   Fund   (MRCF)   is   an    innovative    investment    collaboration    established    in    2007    and    managed    by    Brandon    Capital    Partners    (www.brandoncapital.com.au).      The    MRCF    invests    in    early    stage    development    and    commercialisation    opportunities    emanating    from    its    member    Australian    medical    research    institutes    and    allied    research    hospitals,    which    includes    the    Murdoch    Childrens    Research    Institute.       The    MRCF    IIF,    LP    fund    is    supported        by      AustralianSuper,      StatewideSuper      and      the      Australian      Government      through      its     Innovation      Investment      Fund      (IIF)  program.              The     MRCF     Collaboration     also     acknowledges     the     support     of     the     State     Governments       of     Victoria,     New     South     Wales,  Western    Australia,    Queensland    and    South    Australia.                        



About  Uniseed

Uniseed    is    a    $61    million    commercialisation    fund    operating    at    the    Universities    of    Melbourne,    Queensland    and    NSW,    with     investment   capital   provided   by   the   three   universities   and   Australian   Super,   one   of   Australia’s   largest   superannuation   funds.      Uniseed’s     mandate   is   to   facilitate   the   commercialisation   of     university-­‐generated     intellectual   property     by     targeted   investment   in    highly        promising      technologies.              Uniseed      has      made      over      30      investments      in      technologies      arising      from      its      partner      universities    including    Vintela    (trade    sale    to    Quest    Software    Inc)    and    Fibrotech    Therapeutics    (trade    sale    to    Shire    plc).


About   The     University   of   Melbourne

The    University    of    Melbourne    enjoys    an    outstanding    reputation    with    independently    published    world    rankings    consistently    placing    it    as    a    leader    in    higher    education    in    Australia,    the    Asia-­‐Pacific    and    around    the    globe.       Its    national    and       international     performance     confirms     its     position,     across     a     broad     range     of     disciplines,     as     Australia’s     leading     comprehensive    research-­‐intensive     university.        From   its   ground-­‐breaking     work   towards   development   of   the   bionic   eye,   to     the   individual   research    projects     of   its   academics   and     students,   it   is   uniquely   placed   to   respond   to   major   social,   economic   and   environmental     challenges.


About the  Murdoch  Childrens Research Institute (MCRI)

The    MCRI    discovers    ways    to    prevent    and    treat    conditions   affecting  babies,     children     and     adolescents,   helping   them   lead     happy,   healthy   lives,   working   side   by   side   with     the   doctors   and     nurses   at   The  Royal     Children’s   Hospital.     MCRI   conducts   innovative,   world   class   research   into   conditions   such   as   allergies,   asthma,   brain   injury,  cancer,     cerebral   palsy,   depression,   genetic     conditions,   obesity,   premature   birth     and     infectious   diseases.        The   Australian   Paediatric  Pharmacology    Research    Unit    (APPRU)    is    located    at    the    Murdoch    Childrens    Research    Institute    and    The    Royal    Children’s    Hospital    and    conducts     clinical   trials     in   children   to   investigate   the   safety   and   efficacy   of     prescription   drugs   and   medications   typically   developed  for     adults   to   assess   and   improve   the   safety   and   efficacy   of     such   therapies   for     children.        The   unit’s     primary   focus   is   always   on   the  quality     use   of   medicines   in     children.        APPRU   is   a   specialised     unit   and     is   one   of   only   six   other   similarly   dedicated     units   worldwide  (outside    the    US).