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SUDA Pharmaceuticals progresses with ZolpiMist® commercialisation in Australia

Highlights 

  • SUDA Pharmaceuticals Limited (ASX:SUD) and STADA Pharmaceuticals have entered into an exclusive License and Distribution Agreement for ZolpiMist®.
  • As per the agreement, SUDA will manufacture and supply the product at agreed supply prices.
  • STADA will leverage the TGA approval and commercialise ZolpiMist® in Australia.

In a significant development, SUDA Pharmaceuticals Limited (ASX:SUD) has granted an exclusive Licence for the rights to ZolpiMist® to STADA Pharmaceuticals Australia Pty Ltd for the commercialisation in Australia. STADA Pharmaceuticals is a member of the international pharmaceutical firm, STADA Group.

ZolpiMist® is a US Food and Drug Administration (FDA) approved, oro-mucosal spray formulation of zolpidem tartrate, which was approved by the Therapeutics Goods Administration (TGA) in July 2020. It is used for the short-term treatment of insomnia, characterised by difficulties with sleep initiation.

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According to a survey conducted by the University of Southampton, the incidence of people afflicted with sleep problems surged from one in six to one in four during the coronavirus pandemic. It is worth noting that clinical data supports the faster onset of action of ZolpiMist® over standard tablet forms of the drug, which is a crucial factor for an effective anti-insomnia medication.

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Details of agreement

SUDA and STADA Pharmaceuticals have entered into an exclusive License and Distribution Agreement for ZolpiMist®. The Agreement is a perpetual, exclusive Licence for ZolpiMist® for Australia, in which STADA has the option to distribute the product in New Zealand.

As per the terms of the agreement, SUDA will receive an upfront fee of AU$170,000 as well as a milestone payment of AU$40,000. This milestone payment is associated with the approval of the enhanced child resistant lock (CRL). Moreover, SUDA will receive a 10 per cent royalty on the basis of net sales of the enhanced product.

While SUDA will manufacture and supply the product at agreed supply prices, STADA is responsible for commercialisation of the product in Australia. Notably, the agreement is subject to standard termination clauses.

Way ahead

SUDA already holds the approval from the Therapeutic Goods Administration (TGA) for ZolpiMist® and continues to work closely with its current licensees. The Company intends to submit an additional application to the TGA for a modification to the current spray unit while including in the application a more elegant, economical, and user-friendly child resistant lock. It is expected that the new CRL will be implemented from the second batch of product manufactured for STADA onward.

STADA will leverage the TGA approval and commercialise ZolpiMist® in Australia. Commercial sales are expected to commence in the third quarter of the calendar year 2022.

As of 4:01 PM AEST, SUDA shares are trading at AU$0.048, with a rise of over 2 per cent.

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