Jun 21, 2021
VIRALEZE UK update (ASX Announcement)
Melbourne, Australia; 21 June 2021: Starpharma (ASX: SPL, OTCQX: SPHRY) advises that its UK retail partner, LloydsPharmacy, has received correspondence from the UK Medicines and Healthcare products Regulatory Agency (MHRA) in relation to specific promotional claims made for VIRALEZE™ antiviral nasal spray. The correspondence relates to promotional claims, including references to SARS-CoV-2 and COVID-19, and the interrelationship between these product claims and its categorisation. The MHRA correspondence does not question or relate to the safety or quality of VIRALEZE™, but relates to allowable promotional claims.
Starpharma, LloydsPharmacy and their expert advisers are engaging with the MHRA to resolve the matter as quickly as possible. While Starpharma disagrees with the MHRA’s position, Starpharma and LloydsPharmacy have agreed to temporarily pause sales of VIRALEZE™ in the UK during this time. Starpharma has generated extensive data, including published data, in relation to the broad-spectrum antiviral activity and the mechanism of action for VIRALEZE™ supporting the product and its promotional claims. During development and prior to the launch of VIRALEZE™, Starpharma obtained expert regulatory advice and input from an EU regulatory body in relation to the product and its claims.
This temporary pause in promotion and sales is specific to the UK and does not impact other markets, including in Europe and India where the product is registered for sale. VIRALEZE™ continues to be available in multiple countries via www.viraleze.co.
Starpharma is rapidly progressing commercial and supply arrangements for the Indian market, for both the private (consumer) and Government markets. Starpharma also continues to prioritise regulatory activities for VIRALEZE™ for a number of other important markets. VIRALEZE™ is not yet approved in Australia.
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 a broad spectrum of respiratory viruses, including multiple variants of 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™ is intended to be used alongside vaccines, masks, and physical distancing.
1 Paull J.R.A., et al. Virucidal and antiviral activity of astodrimer sodium against SARS-CoV-2 in vitro. Antiviral Res 2021;191:105089 (https://doi.org/10.1016/j.antiviral.2021.105089)
Download ASX Announcement: VIRALEZE UK update (PDF 520kb)