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

  • Jul 30, 2020 AEST
  • Team Kalkine
SUDA Reaches Major Milestone with Grant of TGA Approval for ZolpiMist<sup>TM</sup>, Stock Rallies Above 150%

Summary

  • SUDA attained a significant milestone with the receipt of TGA approval for its lead product ZolpiMistTM.
  • The approval is achieved ahead of projected deadline of Q4 2020.
  • TGA approval enables ZolpiMistTM 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 ZolpiMistTM.

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 ZolpiMistTM (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 ZolpiMistTM 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 ZolpiMistTM at a more competitive supply price and potentially allows it to target additional territories.

TGA approval offers following benefits to SUDA:

  • ZolpiMistTM 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 ZolpiMistTM 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 ZolpiMistTM 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.

ZolpiMistTM SUDA’s Lead Commercial Product

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

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

SUDA has out-licensed ZolpiMistTM 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 ZolpiMistTM.

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

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

Management Commentary

Must Read! SUDA Seeking Participation in $3.56M Capital Raising, Eyeing development of Anagrelide and OroMist Assets

 


Disclaimer
The website https://kalkinemedia.com/au is a service of Kalkine Media Pty. Ltd. A.C.N. 629 651 672. The article has been prepared for informational purposes only and is not intended to be used as a complete source of information on any particular company. The above article is sponsored but NOT a solicitation or recommendation to buy, sell or hold the stock of the company (or companies) or engage in any investment activity under discussion. We are neither licensed nor qualified to provide investment advice through this platform. All pictures are copyright to their respective owner(s). Kalkinemedia.com does not claim ownership of any of the pictures displayed on this website unless stated otherwise. Some of the images used on this website are taken from the web and are believed to be in public domain. We have used reasonable efforts to accredit the source (public domain/CC0 status) to where it was found and indicated it below the image.

 

There is no investor left unperturbed with the ongoing trade conflicts between US-China and the devastating bushfire in Australia.

Are you wondering if the year 2020 might not have taken the right start? Dividend stocks could be the answer to that question.

As interest rates in Australia are already at record low levels, find out which dividend stocks are viewed as the most attractive investment opportunity in the current scenario in our report.

CLICK HERE FOR YOUR FREE REPORT!
   
x
We use cookies to ensure that we give you the best experience on our website. If you continue to use this site we will assume that you are happy with it. OK