Starpharma (ASX: SPL) has made significant commercial and regulatory progress with its VIRALEZE antiviral nasal spray with the EU regulatory dossier more than 90% complete and the product is now on track to be registered, and ready for market in Q1 CY2021. This timing is earlier than previously announced.
VIRALEZE will be marketed as an antiviral nasal spray for SARS-CoV-2 (the coronavirus that causes COVID-19) as well as other important respiratory viruses (influenza and RSV). The product is expected to form part of a range of preventative measures such as masks and other PPE, and is complimentary to COVID-19 vaccines to further reduce risk of infection.
According to Starpharma, pre-launch commercialisation activities for VIRALEZE are well advanced with input from Boston Consulting Group (BCG), focussing initially on direct to consumer and B2B (business-to-business) channels to facilitate the most rapid entry to market.
Starpharma is continuing partnering discussions in parallel. Europe will be the first geographic region for the VIRALEZE launch. The company plans to leverage the European registration to roll-out VIRALEZE into other markets including Australia as quickly as possible.
As part of the go-to-market planning for VIRALEZE, BCG conducted qualitative and quantitative consumer research in Europe during November. The research from ~1,500 consumers confirmed that the product proposition for VIRALEZE is highly appealing, and that consumers would use the product in a wide range of settings including in crowded areas such as shopping centres, elevators, workplaces and public transport.
The research showed a high number of respondents (~60%) liked VIRALEZE and that this translated to very high purchase intent – higher than 80% in millennials, with the following features of VIRALEZE driving strong purchase intent:
- Broad spectrum antiviral activity (COVID-19, influenza, RSV, and further viral testing ongoing)
- Inactivates >99.99% of SARS-CoV-2 (the coronavirus that causes COVID-19) – with testing completed in strains from multiple geographies
- Preventative spray (VIRALEZE inactivates virus before, and after, exposure to cells)
- Handy and convenient product (easy to use and does not need refrigeration or special handling, to be available OTC)
CEO, Dr Jackie Fairley, said Starpharma’s launch preparations are well advanced with initial launch batches of VIRALEZE scheduled for January 2021 and the company is also building stocks of raw material and components. Starpharma’s internationally accredited manufacturer already supplies marketed VivaGelproducts and has expertise in nasal sprays.
We know from the positive market research that VIRALEZE has the ability to restore confidence and encourage people to resume everyday professional and recreational activities,” Dr Fairley said.
“Our market research also shows that the compelling features and convenience of VIRALEZE are highly appealing to consumers”.
“The distribution challenges of COVID-19 vaccines are well documented including the timing of wide-spread availability and adoption. Even after a vaccine becomes widely available, social distancing, PPE and other measures will continue to be important and VIRALEZE complements other prevention strategies, including vaccines.
“In November, the World Health Organisation stated that someone died every 17 seconds from COVID-19 in Europe. It is with the greatest urgency that Starpharma is working to make this product ready for market as quickly as possible in 1Q CY2021”.
Further validation of the product in the form of antiviral mechanism of action studies for SPL7013 completed at the prestigious Scripps Research Institute confirm that SPL7013 achieves potent inhibition of SARS-CoV-2 ‘spike protein’ binding (>90%) to the cell target. Blocking and targeting of spike proteins is the approach taken in the development of many COVID-19 vaccines including by Moderna and Pfizer.
