SUDA Pharmaceuticals Ltd has taken another step in the commercialisation of ZolpiMist®, a first-in-class oral spray of zolpidem tartrate to treat short-term insomnia, on entering an exclusive licence and distribution agreement for the Australian market.
This agreement is with STADA Pharmaceuticals Australia Pty Ltd – a member of the global, German-based STADA Group.
SUDA is set to receive an upfront payment of $170,000, a milestone fee of $40,000 on the regulatory approval of a specific spay unit enhancement and a 10% royalty on the sales.
The company obtained approval from the Therapeutic Goods Administration (TGA) for ZolpiMist on July 29 and continues to work closely with its current licensees.
CRL modification
SUDA will submit a further application to the TGA for a modification to the current spray unit, incorporating in the application a more economical, elegant and user-friendly child-resistant lock (CRL).
It is anticipated that the new CRL will be implemented from the second batch of product produced for STADA onward.
Progressing commercial build-out
According to a survey conducted by the University of Southampton, the incidence of people suffering from sleep problems rose from one in six to one in four during the COVID19 pandemic.
Clinical data supports the faster onset of action of ZolpiMist over conventional tablet forms of the drug, which is a critical factor for an effective anti-insomnia medication.
SUDA executive director of business development David Phillips said: “We are very excited about developing the partnership with STADA, who have strong credentials to successfully market ZolpiMist in Australia and potentially in other territories.
“By completing an agreement in Australia, we continue to make progress for the commercial build-out of ZolpiMist.
“This partnership is anticipated to lead to SUDA’s first revenue stream from the commercialisation of a product from our portfolio.”
Commercial sales from Q3 2022
STADA has advised SUDA that commercial sales are expected to kick off in Q3 2022.
STADA Pharmaceuticals Australia general manager for Australia and New Zealand Helen Tye said the company was pleased to licence this product from SUDA and looked forward to facilitating patients.
“This agreement serves as further evidence that STADA is increasingly a go-to-partner for specialty pharmaceuticals in Australia.”
She said: "STADA is committed to providing medicines that may provide relief for patients suffering from various conditions.
"Sleep problems can impact on people’s overall health both mentally and physically, with insomnia sufferers reporting a lower quality of life compared with people who are sleeping well.
"STADA believes that nobody should have to compromise their quality of life or give up what they would like to do because of a medical condition."