Starpharma's VivaGel® Condom Receives Regulatory Approval in Canada

Medical Device Investing

Starpharma Holdings 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, plans to launch the VivaGel® condom in Canada as soon as possible under the LifeStyles® Dual Protect™ brand.

MELBOURNE, Australia–(BUSINESS WIRE)–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.
About VivaGel®
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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