Ann: VIRALEZE UK Update, page-2

VIRALEZE UK update
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.