Dec 10, 2020

VIRALEZE™ COVID-19 nasal spray to be ready for market Q1CY21

VIRALEZE™ COVID-19 nasal spray to be ready for market Q1CY21
  • EU regulatory dossier >90% complete and VIRALEZE™ now on track to be registered, and ready for market in Q1 CY2021, earlier than previously announced
  • Initial launch batches of VIRALEZE™ scheduled for manufacture in January 2021; Starpharma is also building inventory of components and raw material to support rapid roll-out
  • Launch and marketing preparations well advanced, including discussions with pharmacy chains, B2B customers, qualitative and quantitative consumer market research; partnering discussions are continuing in parallel
  • VIRALEZE™ clinical study in healthy volunteers to commence in January 2021, for completion in Q1 CY2021
  • SPL7013 has been shown to be virucidal, inactivating more than 99.99% of SARS-CoV-2 and Scripps Research Institute mechanistic studies have confirmed potent inhibition of viral ‘spike protein’ binding (>90%)
  • The broad spectrum antiviral activity of VIRALEZE™ is a compelling differentiating feature and Starpharma is continuing to build additional efficacy data in other respiratory viruses to further broaden the product claims for VIRALEZE™

Melbourne, Australia; 10 December 2020: Starpharma (ASX: SPL, OTCQX: SPHRY) announced significant commercial and regulatory progress has been made for VIRALEZE™ nasal spray with the EU regulatory dossier more than 90% complete and VIRALEZE™ 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). VIRALEZE™ 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.

Starpharma’s 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. Starpharma 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)

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 VivaGel® products and has expertise in nasal sprays.

Starpharma is leveraging the extensive data already available for the active (SPL7013) in VIRALEZE™. VIRALEZE™ will be approved via the CE mark route. The Company is also conducting a clinical study in healthy volunteers to be completed in Q1 CY21 to support commercialisation activities for VIRALEZE™, noting that this study is not a requirement for registration.

Dr Jackie Fairley, CEO of Starpharma commented: “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. 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[1]. 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.

About VIRALEZE™

VIRALEZE™ is an antiviral nasal spray for coronavirus and other viruses such as influenza and respiratory syncytial virus (RSV). VIRALEZE™ is an easy to use preventative nasal spray, which can be stored at room temperature and does not require refrigeration.

VIRALEZE™ contains SPL7013, a broad spectrum antiviral, which is the active in products approved in more than 40 countries and on market in the UK, Europe, Asia, Australia and New Zealand.

SPL7013 has been shown in laboratory studies to be virucidal, inactivating more than 99.99% of SARS-CoV-2 (the coronavirus that causes COVID‑19), when applied to the cells before or after exposure to the virus.

The broad spectrum antiviral activity of VIRALEZE™ is a compelling differentiating feature and means that the product could have an important role in future pandemics.

Download full announcement: VIRALEZE™ COVID-19 nasal spray to be ready for market Q1CY21 (PDF 113kb)

[1] https://www.smh.com.au/world/europe/someone-in-europe-is-dying-every-17-seconds-from-covid-19-who-says-20201120-p56gag.html

 This contains certain forward-looking statements.