VivaGel® condom receives regulatory approval in Canada
13 September 2016
Melbourne, Australia; Starpharma Holdings Ltd (ASX: SPL, OTCQX: SPHRY) today announced it had been granted a medical device license for the VivaGel® condom by the Canadian regulatory authority, Health Canada.
Starpharma’s marketing partner, Ansell (ASX: ANN), plans to launch the VivaGel® condom in Canada as soon as possible under the LifeStyles® Dual Protect™ brand.
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 the proprietary compound, astodrimer sodium (SPL7013, VivaGel®) in the condom lubricant.
Starpharma Chief Executive Officer, Dr Jackie Fairley, said, “The approval by Health Canada marks a further key commercial milestone for the VivaGel® condom product, and is very significant as the first North American approval for the product.”
Jeyan Heper, Ansell’s President and General Manager, Sexual Wellness Global Business Unit said “Ansell's mission is to provide innovative solutions for safety, well-being and peace of mind. We pride ourselves on our innovative products and the LifeStyles® Dual Protect™ condom is a great example of this, combining a high-quality condom with Starpharma's VivaGel®, a patented anti-viral technology.”
Regulatory reviews continue for the VivaGel® condom in a number of other geographic regions with further approvals anticipated in the coming months.
In May 2016, Starpharma and Ansell announced that VivaGel® condoms were provided to Australian athletes ahead of the Olympics in Rio de Janeiro. The antiviral condoms are also available for Australian athletes at the Paralympics.
VivaGel® has been proven in laboratory studies to inactivate up to 99.9% of HIV (human immunodeficiency virus), HSV (herpes simplex virus) and HPV (human papillomavirus), which are viruses that cause STIs. VivaGel® was also recently shown in laboratory studies to have potent antiviral activity against the Zika virus at levels significantly below the concentration in the Dual Protect™ condom. It is now known that Zika virus can be sexually transmitted.
Customers in Canada can pre-order LifeStyles® Dual Protect™ condoms at www.lifestyles.com/dual-protect, as of Wednesday 14 September 2016.
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