Shares in Starpharma Holdings Limited (ASX: SPH) are on the move today after the company released a market sensitive announcement. At the time of writing, the Starpharma share price is down 7.87% at 82 cents.
The announcement relates to a story in today's The Age regarding the company's Viraleze nasal spray.
Viraleze is an antiviral nasal spray used overseas for the treatment of Covid-19. It is registered for sale in Europe, Vietnam, India, Saudi Arabia, and New Zealand, and "available outside Australia in certain markets online", according to the company.
Starpharma is awaiting the outcome of an application for approval from the Therapeutic Goods Administration (TGA) to sell the product in Australia.
What did the media article say?
The article states that the TGA "believes the company has applied for the wrong therapeutic goods category".
In the article, a TGA spokeswoman is quoted as saying:
The TGA can confirm that Starpharma submitted an application for Viraleze for inclusion in the Australian register of Therapeutic Goods as a medical device. According to the Therapeutic Goods Act 1989 and based on information provided by Starpharma to the TGA and information they have published in the public domain, Viraleze would be a medicine, not a medical device.
The TGA has discussed the differences between a medicine and medical device with Starpharma verbally and in writing on several occasions, as recently as mid-January 2022. To date, Starpharma has not sought advice from the medicines authorisation branch of the TGA nor have they submitted an application for this product to be included in the [register] as a medicine.
What is Starpharma's response?
In its release today, Starpharma affirmed it has submitted an application to the TGA for Viraleze as a medical device. It said this is in line with other countries, and that the regulatory process "is ongoing".
Starpharma said:
Starpharma does not normally comment on ongoing regulatory processes and was not anticipating the TGA to make public comment, given we are currently awaiting a response from the TGA, having provided additional information as recently as last week, including information related to the nasal spray mechanism of action and the appropriateness of its classification as a medical device.
Starpharma's submission for this product as a medical device is consistent with multiple other nasal sprays with antiviral indications that are registered by the TGA as medical devices and have been marketed in Australia for several years.
This is important because, as the company notes, Viraleze is already registered as a medical device in Europe and elsewhere, but also under the Therapeutic Goods Act 1989.
Let's not forget that Starpharma and the TGA have had a fairly colourful past. Last year, the TGA fined Starpharma more than $90,000 for promoting Viraleze on YouTube despite it not yet having approval.
Starpharma stated further:
We appreciate the TGA's important role in regulating the supply of therapeutic goods in Australia and look forward to working with the TGA to achieve registration of the nasal spray in Australia to make the product available to Australian consumers.
It remains to be seen what the TGA will decide regarding Viraleze. The application is still being evaluated.
Starpharma share price snapshot
In the past 12 months, the Starpharma share price has collapsed by 60%. It is trailing the broader S&P/ASX 200 Health Care Index (ASX: XHJ) in 2022. The index is down 15% while the Starpharma share price has lost 37% year to date.
