Australia’s medicines regulator has fined Melbourne biotech Starpharma $93,000 for advertising breaches related to its COVID-fighting nasal spray, just weeks after the UK regulator raised questions about promotions of the product.
The Therapeutic Goods Administration confirmed on Friday evening it had issued the company with seven infringement notices worth $93,200 for promoting its nasal spray Viraleze via its website and YouTube channel even though the product is not yet authorised for use in Australia.
The regulator said the company’s advertising “included a restricted representation claiming that Viraleze is an antiviral nasal spray that stops SARS-CoV-2, the virus that causes COVID-19. Any claims or references to preventing or treating a serious form of a disease, condition, ailment or defect are restricted representations”.
In a statement to the ASX on Monday morning, Starpharma said upon receiving the infringement notices it acted quickly to block Australians from being able to view the materials that the regulator had concerns about, including preventing them from accessing the product’s marketing website and its YouTube channel.
“The company will work closely with the TGA to resolve the current matter and how to balance the need to provide information to its shareholders about key company milestones…with requirements of the [Therapeutic Goods] Act in relation to advertising in Australia,” Starpharma said.
Starpharma is an ASX-listed pharmaceuticals developer which currently sells a range of sexual health products including antiviral condoms.
The company pivoted its research towards coronavirus in the middle of 2020 and developed Viraleze, an antiviral nasal spray, using the same active ingredient that is in its other products.
Viraleze, which has undergone laboratory testing, is designed as a preventative measure against the virus to be used as an additional layer of protection on top of mask wearing, social distancing and vaccines.