Australian biotech firm Starpharma (ASX: SPL) says it has achieved a major milestone with the receipt of Conformity Assessment Certification for the VivaGel (vaginal microbicide against sexually-transmitted infections) condom by the Australian Therapeutic Goods Administration (TGA). This TGA certification is similar to CE certification of devices (CE Mark) in Europe.
Starpharma’s marketing partner, Ansell (ASX: ANN) plans to launch the VivaGel condom under its 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 (undisclosed) royalties based on sales.
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