Ann: ZolpiMist Clinical Results Published, page-38

https://finance.yahoo.com/news/aytu-bioscience-announces-submission-zolpimist-120500737.html

Australian TGA Approval Decision Expected in Early 2020

ENGLEWOOD, CO / ACCESSWIRE / April 24, 2019 / Aytu BioScience, Inc. (AYTU), a specialtypharmaceutical company focused on global commercialization of novel productsaddressing significant medical needs, today announced the submission ofZolpiMist^™ (zolpidem tartrate oral spray) forregulatory approval to the Australian Therapeutic Goods Administration (TGA).SUDA Pharmaceuticals Ltd (''SUDA''), which holds the global ZolpiMistsublicense outside the U.S. and Canada, has made this submission and furtherdisclosed that the TGA has accepted the ZolpiMist Marketing AuthorisationApplication (MAA) for review and the review is underway.

AytuBioScience previously announced its partnership with SUDA Pharmaceuticals asthe licensee of ZolpiMist outside the U.S. and Canada, and SUDA already hasmultiple sublicensing agreements in place around the world. This submission tothe Australian TGA represents SUDA's first direct regulatory submission, andthe expected review period is 255 days. Accordingly, a decision by TGA isexpected in early calendar 2020.

JoshDisbrow, Chief Executive Officer of Aytu BioScience commented, ''Wecongratulate SUDA Pharmaceuticals on their successful submission of theZolpiMist regulatory file to the Australian TGA. As the TGA is one of theworld's most rigorous regulatory bodies, we are encouraged by the agency'sprompt preliminary assessment and acknowledgement of the file's completenessand readiness for full review. We look forward to the potential approval ofZolpiMist early next year following the completion of TGA's review.''

Ayturecently announced the global licensing agreement for ZolpiMist with SUDA. TheAytu-SUDA licensing agreement calls for SUDA to lead commercial development andsublicensing efforts for ZolpiMist in major territories outside the UnitedStates and Canada, including Europe, Asia, Australia, and Latin America. Asspecified in the companies' global licensing agreement, SUDA will pay Aytu aportion of each upfront and milestone payment received from sublicensees, andAytu will receive ongoing royalty payments on sales generated by SUDA andSUDA's sublicensees as ZolpiMist is launched in their territories.

SUDAhas 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 Asia.

SUDAis in negotiations with pharmaceutical companies to sublicense ZolpiMist inadditional countries in South America, as well as in Europe (specifically inSpain, Italy, France, and Germany), Korea, the Middle East, North Africa, UAE,and Kuwait.

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