Pharmacy Daily | Starpharma fined over COVID-19 spray

ASX-LISTED biopharmaceutical firm Starpharma Holdings Limited has been fined $93,240 for unlawful advertising of its Viraleze spray in relation to COVID-19.

Seven infringement notices were issued by the Therapeutic Goods Administration (TGA) after the company allegedly promoted the use and supply in Australia of the product, which was not entered on the Australian Register of Therapeutic Goods.

Viraleze is currently registered for sale in Europe and India, and is described by the company as "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".

The TGA alleges that the unauthorised advertising, on two of Starpharma's websites as well as its YouTube channel, included a restricted representation claiming Viraleze is an antiviral nasal spray that stops COVID-19.

"Any claims or references to preventing or treating a serious form of a disease, condition, ailment or defect are restricted representations," the TGA said.

The agency also highlighted "references to the substance Astodrimer sodium that is included in Schedule 3 (Pharmacist Only Medicine) of the current Poisons Standard.

"The reference to Astodrimer sodium in relation to SARS-CoV-2 is not permitted in advertising to consumers and was not authorised or required by a government or government authority," the TGA notice added.

Earlier this year Starpharma trumpeted a major new UK sales and distribution deal for Viraleze with Britain's LloydsPharmacy Group (PD 30 Mar).

However last month the company announced a "temporary pause in promotion and sales" in the UK, after the country's Medicines and Healthcare products Regulatory Agency (MHRA) wrote to LloydsPharmacy "in relation to specific promotional claims made for Viraleze antiviral nasal spray" prompting a withdrawal from sale.

The Starpharma website notes that Viraleze has been approved for sale in India and Europe, and is sold online in some markets via the company's viraleze.co webstore.

"Starpharma is also progressing regulatory activities for a number of markets, including Australia, with the intention of rolling it out across other markets," the company said.

Starpharma was awarded development funding for the development and commercialisation of Viraleze by the Australian Government's Medical Research Future Fund Biomedical Translation Bridge Program.