The Starpharma Holdings Limited (ASX: SPL) share price is up 6% following a company announcement to the market this morning.
Starpharma has announced it will relaunch its VIRALEZE antiviral nasal spray in the UK after resolving issues raised by the regulator in June last year. Supply preparations are already underway and the product will be back online and in pharmacies over the next few weeks.
Starpharma share price spikes after regulator's tick of approval
ASX investors have reacted strongly to the news today. The Starpharma share price is heading northwards for a fourth consecutive day. It is currently up 6% on Monday's closing price, trading at 96 cents.
Starpharma paused the sale and promotion of VIRALEZE in the UK after the Medicines and Healthcare Products Regulatory Agency (MHRA) wrote to its UK retail partner, LloydsPharmacy querying promotional claims about VIRALEZE and its impact on COVID-19.
As my Fool colleague Kerry Sun wrote at the time, the correspondence related to "references to SARS-CoV-2 and COVID-19, and the interrelationship between these product claims and its categorisation".
MHRA was not questioning the safety or quality of VIRALEZE. It was querying "allowable promotional claims" under the product's categorisation as a medical device.
On the day of that announcement, the Starpharma share price nosedived by 9.4% to $1.54.
In laboratory studies, VIRALEZE has proven effective in deactivating many respiratory viruses, including influenza and multiple strains of COVID-19.
In its statement today, Starpharma told ASX investors that it had provided MHRA with "extensive technical
information" on VIRALEZE and its anti-viral agent, SPL7013. Overnight, the regulator gave the green light for Starpharma to recommence sales in the UK.
What did management say?
Starpharma CEO Dr Jackie Fairley said:
We are delighted to be relaunching VIRALEZE in the UK. We look forward to making VIRALEZE available to UK consumers again very soon. VIRALEZE is registered in more than 30 countries, and we look forward to rolling the product out into further markets this year.
VIRALEZE is registered as a medical device in the UK and countries across Europe, Asia, and the Middle East. It is not approved for sale in Australia.
Starpharma share price recap
The Starpharma share price hit a 52-week low of 79 cents in the middle of March. ASX investors who picked up Starpharma shares at this price have seen a 21% return on their investment in just over two weeks.
