Jun 11, 2021

VIRALEZE antiviral nasal spray registered for sale in India (ASX Announcement)

VIRALEZE antiviral nasal spray registered for sale in India (ASX Announcement)
  • VIRALEZE has been registered for sale nationally in India
  • VIRALEZE™ is a broad spectrum antiviral nasal spray that contains astodrimer sodium (SPL7013) which is virucidal, irreversibly inactivating >99.9% of SARS-CoV-2 (the virus that causes COVID-19) within one minute[1]
  • The active in VIRALEZE is also highly active against multiple strains and variants of SARS-CoV-2, including the Alpha variant and further testing is underway with other Variants of Concern[2]
  • Consumers in India can already purchase VIRALEZE via viraleze.co for personal use and this registration will expand this access
  • Commercial discussions with commercial partners in India for distribution into both the private (consumer) and Government markets are well advanced
  • Starpharma is also progressing discussions for B2B sales with a number of companies in India

Melbourne, Australia; 11 June 2021: Starpharma (ASX: SPL, OTCQX: SPHRY) today announced it had received confirmation that VIRALEZE antiviral nasal spray has been registered for sale nationally in India via the Central Drugs Standard Control Organisation (CDSCO), which is part of the Indian Ministry of Health and Family Welfare. Consumers in India can currently purchase VIRALEZE via www.viraleze.co, and discussions to finalise local distribution arrangements with potential commercial partners into both the private (consumer) and Government markets are well advanced. Starpharma is also progressing product supply preparations for the Indian market.

India has a population of more than 1.3 billion and the ongoing COVID-19 crisis in the country has seen the death toll surpass 359,000 people, and more than 29 million cases.[3] At the peak of the crisis, there were more than 400,000 cases being reported per day, the highest of any country since the pandemic began.

VIRALEZE is an easy-to-use antiviral nasal spray, which can be stored at room temperature and does not require cold storage or specialised transportation. It contains SPL7013 (astodrimer sodium), which has been shown in laboratory studies to inactivate a broad spectrum of respiratory viruses, including >99.9% of coronavirus SARS-CoV-2 (the virus that causes COVID-19). SPL7013 has been shown to be virucidal, rapidly inactivating >99.9% of SARS-CoV-2 within 60 seconds[4] with potent antiviral activity shown in multiple strains and variants of the virus.

The active in VIRALEZE has also been shown to be highly active against multiple strains and variants of SARS-CoV-2, including the Alpha variant, a Variant of Concern, which is the second most common variant reported in India[5] and has been responsible for COVID-19 cases in ~135 countries to date[6]. Further testing is underway with other Variants of Concern.

VIRALEZE™ antiviral nasal spray complements other COVID-19 prevention strategies, including vaccines. It has special relevance in areas of high population density, and where social distancing is not possible and in high-risk environments like travel, hotel quarantine, and sporting events (e.g. Cricket matches, Olympics etc).

Dr Jackie Fairley, CEO of Starpharma, commented: “India continues to record hundreds of thousands of COVID-19 cases every day. Starpharma has worked extremely hard to achieve expedited registration of VIRALEZE in India given the significant need, and we are pleased that Indian consumers are able to access the product immediately through our webstore www.viraleze.co. We are also well advanced in progressing negotiations for distribution arrangements with potential local commercial partners to enable greater access to the product”.

Starpharma is also progressing regulatory activities for a number of markets, including Australia. The Company will make further announcements upon registration and launch of the product in other countries/regions.

Information on the product is available at www.viraleze.co and consumers can sign up for updates, including on product availability.

About VIRALEZE Antiviral Nasal Spray

VIRALEZE Antiviral Nasal Spray was developed by Starpharma (ASX: SPL) and is registered for sale in Europe and India. It is an easy-to-use antiviral nasal spray containing 1% w/w astodrimer sodium (SPL7013), shown in laboratory studies to inactivate respiratory viruses, including >99.9% of coronavirus SARS-CoV-2.1

VIRALEZE binds to and irreversibly inactivates a broad spectrum of respiratory viruses. Inactivated viruses are blocked from attaching to cells inside your nose and taking hold. In addition to providing a protective antiviral barrier, VIRALEZE provides a moisturising layer to help keep nasal tissue hydrated, protecting it from dryness and damage.

SPL7013 is included in products that are already approved in >45 countries and available for sale in the UK, Europe, Japan, South East Asia, South Africa, Australia, and New Zealand.

VIRALEZE can be used alongside vaccines, masks, and physical distancing.

Advantages of VIRALEZE

  • Broad-spectrum, works against multiple strains of SARS-CoV-2 and multiple respiratory viruses.
  • Potent antiviral activity against multiple strains of SARS-CoV-2.
  • Virucidal, irreversibly and rapidly inactivating >99.9% of coronavirus/SARS‑CoV‑2 within one minute.1
  • Ability to inactivate virus either before or after exposure.
  • Contains a well-tolerated, already marketed active, which is not absorbed into the bloodstream.
  • Provides a moisturising and protective barrier to help keep nasal tissue hydrated.
  • Room temperature storage, easy and convenient for regular use.

Starpharma acknowledges the $1 million in funding for the development of VIRALEZE provided by the Australian Government’s Medical Research Future Fund (MRFF) Biomedical Translation Bridge (BTB) Program, with support from UniQuest. Delivered by MTPConnect, the Australian Government's BTB program is a $22.3 million MRFF initiative that provides up to $1 million in matched funding to nurture the translation of new therapies, technologies and medical devices through to proof of concept to turn innovative medical ideas into reality.

Download ASX Announcement: VIRALEZE antiviral nasal spray registered for sale in India (PDF 520kb)

[1] Paull J.R.A., et al. Virucidal and antiviral activity of astodrimer sodium against SARS-CoV-2 in vitroAntiviral Res 2021;191:105089 (https://doi.org/10.1016/j.antiviral.2021.105089)

[2] A Variant of Concern is a variant of the virus for which there is evidence of certain attributes including increased transmissibility, more severe disease, and reduced vaccine-induced protection from severe disease (https://www.cdc.gov/coronavirus/2019-ncov/variants/variant-info.html#Concern and https://www.ecdc.europa.eu/en/covid-19/variants-concern)

[3] India Population (2021) - Worldometer (worldometers.info)   India COVID-19 Crisis | UNICEF Australia Emergency Appeal

India: WHO Coronavirus Disease (COVID-19) Dashboard With Vaccination Data | WHO Coronavirus (COVID-19) Dashboard With Vaccination Data

[4] Paull J.R.A., et al. Virucidal and antiviral activity of astodrimer sodium against SARS-CoV-2 in vitroAntiviral Res 2021;191:105089 (https://doi.org/10.1016/j.antiviral.2021.105089)

[5] https://aci.health.nsw.gov.au/covid-19/critical-intelligence-unit/sars-cov-2-variants

[6] https://cov-lineages.org/global_report_B.1.1.7.html

 This contains certain forward-looking statements.