Aytu BioScience Announces ZolpiMist Global Distribution Agreement with SUDA Pharmaceuticals

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Aytu Assumes Milestone & Royalty-Based Licensing Agreement with SUDA Pharmaceuticals to Sublicense ZolpiMist Outside of the United States and CanadaENGLEWOOD, CO / ACCESSWIRE / March 6, 2019 / Aytu BioScience, Inc. (AYTU), a specialty pharmaceutical company focused on commercializing novel products that address significant patient needs, today announced the Company's licensing agreement with SUDA Pharmaceuticals Ltd (ASX:SUD) to distribute ZolpiMist™ (zolpidem tartrate oral spray) outside the United States and Canada. ZolpiMist is a rapidly acting oral spray sleep aid and is the only FDA-approved oral spray formulation of zolpidem tartrate. Zolpidem tartrate tablets are marketed in the U.S. under the brand name Ambien®.SUDA Pharmaceuticals is a drug delivery company focused on oro-mucosal administration and is headquartered in Perth, Western Australia. SUDA has been granted the exclusive license to market and distribute ZolpiMist in major markets outside the United States and Canada. Aytu has assumed this perpetual, exclusive global licensing agreement with SUDA from Magna Pharmaceuticals, the former NDA holder of ZolpiMist.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, and Latin America. The 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.SUDA has already signed sublicensing agreements in key markets with large, multi-national pharmaceutical companies and has agreements in place in China, Chile, Brazil, and throughout Southeast Asia. Additional sublicensing discussions are ongoing with additional prospective sublicensees for Mexico and other geographies.Josh Disbrow, Aytu BioScience's Chief Executive Officer commented, ''We are pleased to be partnering with SUDA as they develop ZolpiMist commercial opportunities around the world. In a short period of time the SUDA team has entered into several sublicensing arrangements with prominent pharmaceutical companies. As such, we expect to see regulatory clearance in at least one market in the coming year. We thank CEO Stephen Carter and the SUDA team for their partnership and look forward to working with SUDA as they continue their ongoing commercial efforts with ZolpiMist around the world.''Stephen Carter, SUDA Pharmaceuticals' Chairman and Chief Executive Officer added, ''SUDA is pleased to continue its ZolpiMist program with Aytu. We have a number of discussions in place to further the global footprint of the ZolpiMist brand. We are looking forward to the ongoing achievement of commercial milestones and the continued roll out of regulatory submissions with our partners.''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's sublicensees as ZolpiMist is launched in their territories.More information about SUDA's licensing agreements can be found on the SUDA Pharmaceuticals corporate website in the company's announcements section at:http://sudapharma.com/index.php/asx-announcements