SUDA Reaches Major Milestone with Grant of TGA Approval for ZolpiMist^TM, Stock Rallies Above 150%

Summary

• SUDA attained a significant milestone with the receipt of TGA approval for its lead product ZolpiMist^TM.
• The approval is achieved ahead of projected deadline of Q4 2020.
• TGA approval enables ZolpiMist^TM to be sold in Australia, allows more competitive supply price and supports corresponding submissions in additional territories.
• SUDA is also actively continuing discussions with other territories to license ZolpiMist^TM.

SUDA Pharmaceuticals Limited (ASX:SUD) soared above 150 per cent to $0.068 on ASX on 29 July 2020, following the announcement regarding grant of Therapeutics Goods Administration’s (TGA) approval for ZolpiMist^TM (zolpidem tartrate). Notably, the stock touched day’s high of $0.097.

SUDA notified in its latest update that the TGA has approved the registration of ZolpiMist^TM for the treatment of short-term insomnia in adults. While the completion of TGA review was expected in Q4 2020, the Company has achieved the approval ahead of its projected deadline.

Receipt of TGA Approval - A Major Breakthrough

TGA approval incorporates the supplemental active pharmaceutical ingredient (API) supplier and final product manufacturer that enables the Company to supply ZolpiMist^TM at a more competitive supply price and potentially allows it to target additional territories.

TGA approval offers following benefits to SUDA:

• ZolpiMist^TM will be incorporated on the ARTG (Australian Register of Therapeutic Goods) and can be supplied and commercialised within Australia.
• The approval reflects SUDA’s compliance with Good Manufacturing Practice and its ability to obtain regulatory consents for its products.
• The approval will support SUDA’s current partners, Mitsubishi Tanabe Pharma (MTP) Singapore, TEVA and MTP Korea, in their submissions in their corresponding territories with the amended API supplier and product manufacturer.

Background to the TGA Application

SUDA submitted a Marketing Authorisation Application for ZolpiMist^TM to the TGA in April last year and subsequently made a strategic decision to register a supplemental API supplier and product manufacturer.

The outcome of strategic decision was to reduce the costs of raw material and finished product that would enable the Company to create additional value over the medium to long-term from its present partnerships and to establish further partnerships across more territories.

SUDA decided to source API from a well-known, international generics manufacturer and announced manufacturing and packaging of ZolpiMist^TM by the Australian subsidiary of a prominent global manufacturer of over-the-counter and generic prescription pharmaceuticals.

This strategic decision needed an amendment to the TGA submission, for which SUDA submitted additional data to the TGA in May 2020, backing the quality of the product being generated utilising the new API supplier and manufacturer.

ZolpiMist^TM –SUDA’s Lead Commercial Product

The oro-mucosal spray version of insomnia drug Ambien (zolpidem tartrate), ZolpiMist^TM, is SUDA’s lead commercial product that has a faster onset of action than the pill form.

SUDA has the rights to market ZolpiMist^TM in all regions outside of the US and Canada, while Aytu BioScience has the rights for both these countries.

SUDA has out-licensed ZolpiMist^TM rights to Teva Pharmaceuticals for Mexico, Chile and Brazil, and to two distinct divisions of Mitsubishi Tanabe for Malaysia, Singapore, Korea and the Philippines. The Company is also actively continuing discussions with other territories to license ZolpiMist^TM.

Recently, Edison Research, the international life science research group, has placed a value of $18m or $0.13 per share on SUDA, considering only ZolpiMist^TM and the present territories for which the Company holds licence agreements.

As the population of current licensed territories for ZolpiMist^TM totals over 550 million people, the market opportunity appears quite large for SUDA.

Management Commentary

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