An Australian-developed virus-killing condom is a step closer to sale, following a key regulatory approval.
Australian biotech firm Starpharma has developed an antiviral compound called VivaGel that laboratory tests have shown can inactivate up to 99.9 per cent of HIV, herpes and some other sexually transmitted viruses, reducing the risk of transmission.
It has teamed up with the world’s second biggest condom maker, Australian-based Ansell, to come up with a range that incorporates this antiviral coating in the lubricant.
These condoms have now received Conformity Assessment Certification from Australia’s Therapeutic Goods Administration (TGA).
Starpharma’s chief executive Dr Jackie Fairley says this approval means that the condoms should be available to consumers in Australia within months.
“There is a final step, which is a relatively rapid step which is likely to be a matter of a few weeks for listing on the ARTG,” she said.
“The product will be, therefore, expected to be launched quite soon, so probably within the next few months.”
‘Condoms not 100 per cent effective’
While condoms are currently considered the best protection against sexually transmitted infections for those engaging in sexual activity, Dr Fairley says they are not foolproof.
“Condoms are not 100 per cent effective in preventing either pregnancy or sexually transmitted infections and so anything that you can do to reduce the number of virus particles by inactivating them with a substance like VivaGel would reduce reduce that overall viral load,” she said.
“The more viral particles you’re exposed to, that typically translates into a greater chance of infection.”
That means the Starpharma-Ansell condom also cannot guarantee full protection from sexually transmitted viruses, but that the new product is intended to help further reduce the chance of infection.
Dr Fairley says there are no current plans to develop the antiviral product for use as a standalone gel, such as in the form of a lubricant, but the company is not ruling that out for the future.
“That’s just not a program that we are focussing on currently,” she said.
Dr Fairley says VivaGel does have both antiviral and antibacterial properties, but the claims tested by the TGA are solely related to the viruses it was tested against in laboratory studies.
‘Significant innovation’ by Australian firms
The gel is currently undergoing trials in the US for use in the treatment of bacterial vaginosis, but has had a setback in some clinical trials where it was intended as an alternative to antibiotic treatment of the condition but rejected by the US Food and Drug Administration (FDA) for this purpose.
However, Dr Fairley says the company has agreement from the FDA for a trial of VivaGel in preventing bacterial vaginosis recurrence, which typically occurs within 12 months for about 50 per cent of women suffering the condition, and is hopeful this trial will be more successful.
Despite setbacks in some of the gels proposed applications, Dr Fairley says the pending launch of the gel coated condoms in Australia with Ansell, and Japan with its biggest condom maker Okamoto, is a huge success for Australian research and industry.
“A globally significant innovation, one that was not only pioneered in Australia, but developed in Australia, and ultimately commercialised by two Australian companies,” she said.
The firm estimates the global branded condom market to be worth over $1 billion per year, and Ansell has global production and distribution rights outside of Japan.
Starpharma shares were up almost 20 per cent to 70 cents by the close of trade on the ASX today, while Ansell was essentially flat, losing 1 cent to $19.06.