Full Press Release Details
Aytu BioScience Announces Submission of ZolpiMist for
Approval to Australian Therapeutic Goods Administration
Australian TGA Approval Decision Expected in Early
ENGLEWOOD, CO / ACCESSWIRE / April 24, 2019 / Aytu
BioScience, Inc. (NASDAQ: AYTU), a specialty pharmaceutical company
focused on global commercialization of novel products addressing
significant medical needs, today announced the submission of
ZolpiMist (zolpidem tartrate oral spray) for regulatory
approval to the Australian Therapeutic Goods Administration (TGA).
SUDA Pharmaceuticals Ltd ( SUDA ), which holds the
global ZolpiMist sublicense outside the U.S. and Canada, has made
this submission and further disclosed that the TGA has accepted the
ZolpiMist Marketing Authorisation Application (MAA) for review and
the review is underway.
BioScience previously announced its partnership with SUDA
Pharmaceuticals as the licensee of ZolpiMist outside the U.S. and
Canada, and SUDA already has multiple sublicensing agreements in
place around the world. This submission to the Australian TGA
represents SUDA's first direct regulatory submission, and the
expected review period is 255 days. Accordingly, a decision by TGA
is expected in early calendar 2020.
Disbrow, Chief Executive Officer of Aytu BioScience commented,
We congratulate SUDA Pharmaceuticals on their successful
submission of the ZolpiMist regulatory file to the Australian TGA.
As the TGA is one of the world's most rigorous regulatory
bodies, we are encouraged by the agency's prompt preliminary
assessment and acknowledgement of the file's completeness and
readiness for full review. We look forward to the potential
approval of ZolpiMist early next year following the completion of
recently announced the global licensing agreement for ZolpiMist
with SUDA. The Aytu-SUDA licensing agreement calls for SUDA to lead
commercial development and sublicensing efforts for ZolpiMist in
major territories outside the United States and Canada, including
Europe, Asia, Australia, and Latin America. As specified in the
companies' global licensing agreement, SUDA will pay Aytu a portion
of each upfront and milestone payment received from sublicensees,
and Aytu will receive ongoing royalty payments on sales generated
by SUDA and SUDA's sublicensees as ZolpiMist is launched in
has already signed sublicensing agreements in key markets with
large, multi-national pharmaceutical companies and has agreements
in place in Brazil, China, Chile, and throughout Southeast
in negotiations with pharmaceutical companies to sublicense
ZolpiMist in additional countries in South America, as well as in
Europe (specifically in Spain, Italy, France, and Germany), Korea,
the Middle East, North Africa, UAE, and Kuwait.
global sleep aid market is currently estimated at almost $50
billion in annual revenue, and annual revenue is estimated to reach
nearly $80 billion in 2022.
About Aytu BioScience, Inc.
BioScience is a commercial-stage specialty pharmaceutical company
focused on global commercialization of novel products addressing
significant medical needs. The company currently markets
Natesto , the only FDA-approved nasal formulation of
testosterone for men with hypogonadism (low testosterone, or "Low
T"). Aytu also has exclusive U.S. and Canadian rights to
ZolpiMist , an FDA-approved, commercial-stage prescription
sleep aid indicated for the short-term treatment of insomnia
characterized by difficulties with sleep initiation. Aytu recently
acquired exclusive U.S. commercial rights to Tuzistra XR, the
only FDA-approved 12-hour codeine-based antitussive syrup. Tuzistra
XR is a prescription antitussive consisting of codeine polistirex
and chlorpheniramine polistirex in an extended-release oral
suspension. Additionally, Aytu is developing MiOXSYS , a
novel, rapid semen analysis system with the potential to become a
standard of care for the diagnosis and management of male
infertility caused by oxidative stress. MiOXSYS is commercialized
outside of the U.S. where it is a CE Marked, Health Canada cleared,
Australian TGA approved, Mexican COFEPRAS approved product, and
Aytu is planning U.S.-based clinical trials in pursuit of 510k de
novo medical device clearance by the FDA. Aytu's strategy is to
continue building its portfolio of revenue-generating products,
leveraging its focused commercial team and expertise to build
leading brands within large therapeutic markets. For more
information visit aytubio.com.
About SUDA Pharmaceuticals
Pharmaceuticals Ltd (ASX: SUD) is a drug delivery company focused
on oro-mucosal administration, headquartered in Perth, Western
Australia. The company is developing low-risk oral sprays using its
OroMist technology to reformulate existing pharmaceuticals.
The many potential benefits of administering drugs through the oral
mucosa (i.e.: cheeks, tongue, gums and palate) include ease of use,
lower dosage, reduced side effects and faster response time. SUDA's
product pipeline includes ZolpiMist , a first-in-class oral
spray of zolpidem for insomnia. ZolpiMist is marketed in the USA
and SUDA has rights to the product outside of the U.S. and Canada.
Other products SUDA has in development include oral sprays for the
treatment of: migraine headache; chemotherapy-induced nausea and
vomiting; erectile dysfunction; PAH; epileptic seizures and
pre-procedural anxiety; and cancer.
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