Arovella Therapeutics Ltd (ASX:ALA) welcomes STADA Australia’s commercial launch of ZolpiMist™ (zolpidem tartrate), a product indicated for the short-term treatment of insomnia in adults.
The biotech company is developing low-risk oral sprays that reformulate existing pharmaceuticals. The potential benefits of administering drugs through the oral mucosa – the cheeks, tongue, gums and palate – include ease of use, lower dosage, reduced side effects and faster response time.
Successful manufacturing of product
On July 29, 2020, Arovella announced that the Therapeutics Goods Administration (TGA) had approved the registration of Arovella’s most advanced product, ZolpiMist, an oral spray for the short-term treatment of insomnia.
Subsequently, on August 24, 2021, Arovella announced that it entered into a licence and distribution agreement with STADA Australia.
Following successful manufacturing of the product, STADA has now launched the product in Australia.
Under the terms of the agreement, Arovella will coordinate manufacturing of the product through its Australian manufacturer.
Child-resistant lock
The company is in the process of implementing a more economical, elegant and user-friendly child-resistant lock (CRL).
Arovella will receive a milestone payment of $40,000 upon the anticipated TGA approval of the new CRL, which is expected to be implemented from the second batch of product manufactured.
Once the new CRL has been implemented, Arovella will receive a 10% royalty on net sales of the product for this innovation, in addition to the supply price.
STADA also has an option to commercialise the product throughout New Zealand and is considering expanding its footprint across additional territories.
Early milestone
“This is an exciting milestone for Arovella,” the company's CEO and MD Dr Michael Baker said.
“We expected the product to be commercialised in the third quarter of 2022 and we have achieved that milestone early.
“We see ZolpiMist as an important product to assist with sleep, particularly with the lingering effects of the COVID-19 pandemic.
“It is due to the hard work of our team and our manufacturing partner that we have been able to achieve this milestone. We look forward to continuing and expanding the partnership with STADA.”
About Arovella
Arovella Therapeutics Ltd (ASX:ALA) is a biotechnology company focused on developing therapies to treat human disease. The company’s two focus areas are oncology and conditions that impact the central nervous system.
Arovella is developing its invariant natural killer T (iNKT) cell therapy platform from Imperial College London to treat blood cancers. It is also progressing its DKK1-peptide targeting technology licensed from MD Anderson to be used in conjunction with its iNKT cell therapy platform.
Arovella’s product pipeline includes an oral spray for the platelet-lowering drug anagrelide to treat metastatic disease in the background of high platelets and ZolpiMist, a first-in-class oral spray of zolpidem tartrate to treat short-term insomnia.