Arovella (ASX:ALA) announces commercial launch of ZolpiMist in Australia - Kalkine Media

Highlights

• Arovella Therapeutics Ltd’s (ASX:ALA) oral spray insomnia treatment has been commercially launched in Australia.
• STADA Australia has initiated the nationwide launch of ZolpiMist for short-term treatment of insomnia in adults.
• STADA also has an option to commercialise the product throughout New Zealand.

In a significant development, Arovella Therapeutics Ltd (ASX:ALA) has announced that STADA Australia has initiated the commercial launch for ZolpiMist (zolpidem tartrate). ZolpiMist is a first-in-class, US-approved, fast-acting oral spray version of zolpidem tartrate, indicated for the short-term treatment of insomnia in adults.

Arovella is an Australia-based biotechnology company focused on developing its oral spray delivery technology and its invariant Natural Killer T (iNKT) cell platform to treat cancer and conditions that affect the central nervous system. The Company’s product pipeline includes ZolpiMist and an oral spray for the platelet-lowering drug anagrelide to treat metastatic disease in the background of high platelets.

Background to commercial launch in Australia

On 29 July 2020, Arovella informed that the Therapeutics Goods Administration (TGA) approved the registration of ZolpiMist for the short-term treatment of insomnia in adults.

The TGA approval included the supplemental API (active pharmaceutical ingredient) supplier and final product manufacturer that allows Arovella to supply the product at a more competitive supply price and potentially enables it to target additional territories.

Subsequently, on 24 August 2021, Arovella notified that it entered into a licence and distribution agreement with STADA Australia. STADA has initiated their commercial launch of the product in Australia following successful manufacturing of the product.

Terms of agreement with STADA

Under the terms of the licence and distribution agreement with STADA, Arovella will coordinate the manufacturing of the product via its Australian manufacturer. The Company is in the process of implementing a more economical, elegant, and user-friendly CRL (child resistant lock).

Upon the anticipated TGA approval of the new CRL, Arovella will receive a milestone payment of AU$40,000. The CRL is likely to be implemented from the second batch of product manufactured. After the new CRL has been implemented, the Company will receive a 10 per cent royalty on net sales of the product, in addition to the supply price.

STADA further has an option to commercialise the product throughout New Zealand and could expand its footprint across additional territories.

Arovella’s shares closed the trading session at AU$0.022 on 23 June 2022.