"SUDA is able to provide a breakdown of developments with...

"SUDA is able to provide a breakdown of developments with ZolpiMist by region: ASEAN/Asia: agreement signed with Eddingpharm for China; advanced multi-territory negotiations with large pharma companies for Philippines, Malaysia, Singapore, Thailand, Indonesia, Vietnam, Myanmar, Cambodia, Laos, Brunei, South Korea and India. MENA (Middle East and North Africa): discussions in various stages with companies for the full MENA region as well as specific talks for the United Arab Emirates and Kuwait. South America: agreement signed with Teva for Brazil, Chile and Mexico; advanced negotiations for other countries in the region including Argentina, Peru, Ecuador, Columbia, Uruguay, Bolivia, Central America, Dominican Republic, Paraguay and Venezuela. Europe: advanced negotiations with pharma companies for Spain, Italy, France and Germany.

Eastern Europe: specific talks for the regions of Turkey and Russia. In Australia, SUDA is working with its regulatory consultants to finalise its Marketing Application to the Australian Therapeutic Goods Administration for the approval of ZolpiMist in the Australian market. It is anticipated that the application should be lodged with the TGA in January 2019. SUDA is now looking for a partner for the Australian market. SUDA’s current agreements and all negotiations are based on SUDA’s standard business model where SUDA will supply the product and receive an upfront payment followed by payments for achieving regulatory and sales milestones. Further to these payments, SUDA will receive a handling fee as well as double digit royalties on sales (current 10-year forecast (after approvals) on signed deals is approximately US$60Mn as previously reported). Furthermore, based on the current agreements only, SUDA has already received US$0.7Mn in upfront fees and will potentially receive a further US$1.5Mn (approx. A$2Mn) in milestone payments.