Auris Medical Announces Notices of Allowance for U.S. and European Patent Applications Covering Intranasal Betahistine
September 11 2019 - 9:00AM
Auris Medical Holding Ltd. (NASDAQ: EARS), a clinical-stage company
dedicated to developing therapeutics that address important unmet
medical needs in neurotology and central nervous system disorders,
today announced that the United States Patent and Trademark Office
(USPTO) has issued a notice of allowance for its patent application
entitled “Pharmaceutical Composition Comprising Betahistine” (U.S.
Patent Application No. 15/887,388). In addition, the Company
received an “Intention to Grant” notice from the European Patent
Office (EPO) for its related patent application entitled
“Intranasal Composition Comprising Betahistine” (European Patent
Application 18 703 749.4). Upon issuance, the patents are expected
to expire no earlier than February 2038 and will provide key
intellectual property protection for the Company's intranasal
betahistine program.
The allowed claims cover composition of matter
and methods of use for formulations of betahistine dihydrochloride
for intranasal delivery. The communications from the USPTO and EPO
conclude substantive examination of the patent applications, which
are now expected to issue as patents once the issue fees are paid
and the patent offices conclude their respective administrative
procedures. Auris Medical also has filed corresponding patent
applications that will allow the Company to seek similar patent
protection in other key markets throughout the world.
“We are very pleased to have achieved this major
milestone in the protection of our intellectual property around the
intranasal betahistine program“, commented Thomas Meyer, Auris
Medical’s founder, Chairman and CEO. “The intranasal delivery route
allows for a surprisingly strong increase in betahistine
concentration in the bloodstream compared to the common oral route,
which is expected to result in superior therapeutic benefits. We
look forward to developing this innovation further in order to help
patients who are suffering from vertigo or antipsychotic-induced
weight gain, among other potential medical conditions.”
About Betahistine
Betahistine is a small molecule structural
analog of histamine, which acts as an agonist at the H1 and as an
antagonist at the H3 histamine receptors. Unlike histamine, it
crosses the blood-brain-barrier. It is known to enhance inner ear
and cerebral blood flow, increase histamine turnover and enhance
histamine release in the brain, increase release of acetylcholine,
dopamine and norepinephrine in the brain and to result in general
brain arousal. Betahistine for oral administration is approved in
about 115 countries, with the US being a notable exception, for the
treatment of vertigo and Meniere’s disease. The compound has a very
good safety profile, yet it is also known that its clinical utility
is held back by poor bioavailability. Intranasal administration of
betahistine has been shown to result in 5 to 29 times higher
bioavailability.
About Auris Medical
Auris Medical is a biopharmaceutical company
dedicated to developing therapeutics that address important unmet
medical needs in neurotology and central nervous system disorders.
The company is focused on the development of intranasal betahistine
for the treatment of vertigo (AM-125) and for the treatment of
antipsychotic-induced weight gain and somnolence (AM-201). These
projects have gone through two Phase 1 trials and entered into
proof-of-concept studies in 2019. In addition, Auris Medical has
two Phase 3 programs under development: Sonsuvi® (AM-111) for acute
inner ear hearing loss and Keyzilen® (AM-101) for acute inner ear
tinnitus. The Company was founded in 2003 and is headquartered in
Hamilton, Bermuda. The shares of Auris Medical Holding Ltd. trade
on the NASDAQ Capital Market under the symbol “EARS.”
Forward-looking Statements
This press release may contain statements that
constitute “forward-looking statements” within the meaning of
Section 27A of the Securities Act of 1933 and Section 21E of the
Securities Exchange Act of 1934. Forward-looking statements are
statements other than historical facts and may include statements
that address future operating, financial or business performance or
Auris Medical’s strategies or expectations. In some cases, you can
identify these statements by forward-looking words such as “may,”
“might,” “will,” “should,” “expects,” “plans,” “anticipates,”
“believes,” “estimates,” “predicts,” “projects,” “potential,”
“outlook” or “continue,” or the negative of these terms and other
comparable terminology. Forward-looking statements are based on
management’s current expectations and beliefs and involve
significant risks and uncertainties that could cause actual
results, developments and business decisions to differ materially
from those contemplated by these statements. These risks and
uncertainties include, but are not limited to, Auris Medical’s need
for and ability to raise substantial additional funding to continue
the development of its product candidates, the timing and conduct
of clinical trials of Auris Medical’s product candidates and that
such trials will not meet their endpoints , the clinical utility of
Auris Medical’s product candidates, the timing or likelihood of
regulatory filings and approvals, Auris Medical’s intellectual
property position and Auris Medical’s financial position, including
the impact of any future acquisitions, dispositions, partnerships,
license transactions or changes to Auris Medical’s capital
structure, including future securities offerings. These risks and
uncertainties also include, but are not limited to, those described
under the caption “Risk Factors” in Auris Medical’s Annual Report
on Form 20-F for the year ended December 31, 2018 and future
filings with the Securities and Exchange Commission.
Forward-looking statements speak only as of the date they are made,
and Auris Medical does not undertake any obligation to update them
in light of new information, future developments or otherwise,
except as may be required under applicable law. All forward-looking
statements are qualified in their entirety by this cautionary
statement.
Investor contact: Joseph Green Edison Advisors
for Auris Medical 646-653-7030 jgreen@edisongroup.com
Or
investors@aurismedical.com
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