VivaGel® condom receives TGA device certification
THE ROADHOUSE PHARMACY: Starpharma (ASX: SPL) has received Conformity Assessment Certification for the VivaGel® condom by the Australian Therapeutic Goods Administration (TGA).
The company explained the TGA certification is similar to CE certification of devices (CE Mark) in Europe.
Starpharma said its marketing partner, Ansell (ASX: ANN) plans to launch the VivaGel® condom under their brand, LifeStyles Dual Protect™, in the coming months, following listing on the Australian Register of Therapeutic Goods (ARTG).
TGA certification will also support certain regulatory processes in other markets.
The VivaGel® condom is a world-first product based on innovative Australian technology.
It is the only condom of its type, providing barrier protection and incorporating a proprietary antiviral compound (VivaGel®) in the lubricant.
LifeStyles Dual Protect™ condoms to be marketed by Ansell will carry the VivaGel® brand and Starpharma will receive royalties based on sales.
“Ansell looks forward to rolling out its marketing and sales campaign to support the launch of LifeStyles Dual Protect™ over the coming months with the first product expected to be available on shelves soon,” Ansell president & general manager, Sexual Wellness Global Business Unit, Peter Carroll said.
“Our partnership with Starpharma is a great example of two highly innovative Australian businesses working together to bring to market a ground-breaking new sexual health product.
“New product development is central to Ansell’s business strategy and this highly innovative product is exciting for both companies.”
LifeStyles Dual Protect™ condoms are lubricated with VivaGel® lubricant, which contains 0.5 per cent astodrimer sodium (previously SPL7013, also referred to as VivaGel®).
VivaGel® is intended to help reduce the risk of exposure to viruses that cause STIs, having been shown in laboratory studies to inactivate up to 99.9 per cent of HIV (human immunodeficiency virus), HSV (herpes simplex virus) and HPV (human papillomavirus).
Website: www.starpharma.com