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Pharmaceutical company Starpharma (ASX: SPL) and its retail partner LloydsPharmacy have paused sales of SPL's anti-COVID nasal spray VIRALEZE in the UK after regulators raised concerns over promotional claims.
Shares in SPL have dived in response to the announcement, down 9.12 per cent to $1.54 per share at 11.02am AEST.
In an ASX statement Starpharma says the UK Medicines and Healthcare products Regulatory Agency (MHRA) sent correspondence to the company in relation to specific promotional claims made for VIRALEZE.
The claims of concern include reference 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," says SPL.
"While Starpharma disagrees with the MHRA's position, Starphrama and LloydsPharmacy have agreed to temporarily pause sales of VIRALEZE in the UK during this time."
VIRALEZE was approved for sale in Europe and the UK earlier this year, with testing of the product showing it to be virucidal - rapidly inactivating more than 99.9 per cent of SARS-CoV-2 within 60 seconds.
While specific details of the MHRA's claims were not provided by SPL, the company says it has generated extensive data relating to the efficacy of VIRALEZE, including in relation to its antiviral activity.
The temporary pause of 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.
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