Two-horse race: Auris, Otonomy seek FDA nod for inner-ear therapies

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By Natalie Grover and Divya GroverApril 20 (Reuters) - Doctors have struggled for years to
deliver medication effectively to the inner ear, but two
companies are vying to be first to introduce new treatments
which, if successful, could together chalk up some $800 million
in peak sales.
    Pivotal drug-trial data from Otonomy Inc <OTIC.O> and Auris
Medical Holding AG <EARS.O> is expected to show whether two
competing approaches can address ear disorders associated with
hearing loss and balance.
    Current therapy typically involves injecting steroids into
the middle ear. The steroids are used off-label to treat sudden
changes in hearing and balance. This approach requires patients
to lie on their side, and avoid swallowing, or risk either the
loss of the drug or possible side-effects.
    "The steroids work, but the current method of delivering
them is terrible," said Dr. Darius Kohan, chief of
otology/neurotology at New York-based Lenox Hill Hospital.
    San Diego-based Otonomy and Swiss biotech Auris propose
delivering medicines using different gel-like formulations into
the middle ear, for absorption by the inner ear.
    Otonomy's drug, a formulation of an existing steroid, is
being tested for use in Meniere's disease - a chronic,
progressive condition characterized by dizziness, tinnitus and
hearing loss that affects 600,000 Americans.
    Auris's treatment is being evaluated for use in tinnitus - a
perception of ringing in the ears, often a symptom of underlying
disease. About 250,000 Americans are eligible for Auris's
    No FDA-approved treatments exist for these diseases.

    At least four other companies also have ear drug trials
under way, but are considered far behind. The group includes
Nordmark Arzneimittel GmbH & Co, Sound Pharmaceuticals and
Decibel Therapeutics, as well as Novartis AG <NOVN.S>.
    Otonomy is expected to release late-stage data on its
Meniere's trial in the second half of 2017.
    The drug is expected to generate peak sales of $603 million,
said SunTrust Robinson analyst Edward Nash.
    The delivery technology that Otonomy is using for this
treatment is already being utilized in its FDA-approved
    This, in a way, validates the company's technology, Nash
said, also noting that Otonomy's approach does not require
repeat injections to complete a course of treatment.
    In contrast, Auris's technology necessitates multiple
injections and requires patients to lie still for up to half an
hour post administration.
    Late stage data from Auris's European study is expected in
    "Even if Auris is successful in their second tinnitus trial,
they'd still have to conduct another U.S. trial to win FDA
approval. If the Otonomy trial is positive, they can file right
away for Meniere's," Nash said.
    Auris's treatment could hit peak sales of $250 million,
according to Needham & Co analyst Serge Belanger.
    To be sure, both competitors have suffered trial setbacks,
which forced them to adjust the design of later studies. They
increased the number of patients enrolled and tweaked trial
    Experts are circumspect about declaring a winner.
    Dr. Hinrich Staecker, lead investigator on Auris's U.S.
tinnitus trial, said it was impossible to tell which company had
the leg up until the latest round of research data comes out.

 (Reporting by Natalie Grover and Divya Grover in Bengaluru;
Editing by David Greising and Sayantani Ghosh)
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This article appears in: Stocks , Politics
Referenced Symbols: EARS , NOVN , OTIC

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