Aytu BioScience, Inc., a specialty pharmaceutical company focused on commercializing novel products that address significant patient needs, has announced the licensing agreement with SUDA Pharmaceuticals Ltd 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.
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.”