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Last edited 6 days ago

29-7-2020:  TGA Approval Granted For ZolpiMist

At 1:58 eastern, SUD is up +229.63% on this news.  They closed at 2.7 cps yesterday, and they're trading at 8.9 cps now.

TGA Approval Granted For ZolpiMist™

Highlights:

  • TGA approval achieved ahead of projected Q4 2020 deadline
  • TGA approval enables ZolpiMist to be sold in Australia
  • TGA approval enables more competitive supply price
  • TGA approval supports corresponding submissions in additional territories

PERTH, AUSTRALIA – 29 July 2020:  SUDA Pharmaceuticals Ltd (ASX: SUD), a leader in oromucosal drug delivery, is pleased to announce that the Therapeutics Goods Administration (TGA) has approved the registration of the Company’s lead product ZolpiMist (zolpidem tartrate) for the treatment of short-term insomnia in adults.

As outlined on 12 May 2020, SUDA had submitted a Marketing Authorisation Application (MAA) to the TGA for ZolpiMist in April 2019.  SUDA, subsequent to the submission, made a strategic decision to register a supplemental active pharmaceutical ingredient (API) supplier and final product manufacturer which required an amendment to the TGA submission.  Completion of the TGA review was expected Q4 2020.

The TGA approval includes the supplemental API supplier and final product manufacturer which allows SUDA to supply the product at a more competitive supply price and potentially allows the Company to target additional territories.

The benefits of TGA approval are:

  1. ZolpiMist™ will be included on the Australian Register of Therapeutic Goods and can be commercialised and supplied within Australia;
  2. Demonstrates SUDA’s compliance with Good Manufacturing Practice and an ability to obtain regulatory approvals for its products; and
  3. It will assist our current partners, TEVA, Mitsubishi Tanabe Pharma Singapore and MTP Korea, in their submissions in their respective territories with the amended API supplier and manufacturer.

Dr Michael Baker commented: “The TGA submission was a combined effort by SUDA’s technical team as well as our regulatory consultant, Pharma To Market.  Obtaining the approval indicates the calibre of our staff and is also a key benefit to our partners for ZolpiMist.  We are delighted by the outcome and look forward to seeing the commencement of commercial sales in the foreseeable future.”

--- click on link above for the full announcement ---

[I'd like to say I hold SUD shares, but, alas, I do not.]

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