Starpharma: VivaGel® Condom Receives TGA Device Certification - Launch Preparations to Follow

  Starpharma: VivaGel® Condom Receives TGA Device Certification - Launch
  Preparations to Follow

Business Wire

MELBOURNE, Australia -- July 20, 2014

Starpharma (ASX:SPL) (OTCQX:SPHRY) today announced achievement of a major
milestone with the receipt of Conformity Assessment Certification for the
VivaGel^® condom by the Australian Therapeutic Goods Administration (TGA).
This TGA certification is similar to CE certification of devices (CE Mark) in

Starpharma’s 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

LifeStyles Dual Protect™ condoms to be marketed by Ansell will carry the
VivaGel^® brand and Starpharma will receive royalties based on sales.

Ansell President & General Manager, Sexual Wellness Global Business Unit,
Peter Carroll, said:

“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.

“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

Ansell is a global leader in protection solutions, manufacturing and marketing
condoms across the world and ranked number two globally. In Australia,
Ansell’s share of the condom market is around 70%. The global branded condom
market is estimated to be worth approximately $1.1 billion.

“With the launch of LifeStyles Dual Protect™ expected in the near future,
certification by TGA marks another major milestone for the VivaGel^® condom
and our partnership with Ansell, one of the world’s leading condom companies
and healthcare innovators,” said Starpharma Chief Executive Officer, Dr Jackie

“The LifeStyles Dual Protect™ condom is a great example of a globally
significant innovation pioneered, developed and commercialised by two
Australian companies.”

LifeStyles Dual Protect™ condoms are lubricated with VivaGel^® lubricant,
which contains 0.5% astodrimer sodium (previously SPL7013, also referred to as
VivaGel^®). Condoms can help reduce the risk of pregnancy and condom use may
help reduce the risk of transmission of HIV/AIDS and other STIs. 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% of HIV
(human immunodeficiency virus), HSV (herpes simplex virus) and HPV (human

Extensive international consumer research conducted in condom users confirms a
high level of consumer interest in the VivaGel^® condom concept with more than
80% of participants surveyed rating the product as very interesting and more
than 90% indicating they would buy it.

In Australia, the prevalence of STIs continues to rise. Genital herpes, caused
by HSV, is estimated to affect one in eight Australians aged 25 years and
over, although many people are unaware of their status and can pass on the
infection without knowing.^1 Alarmingly, the rate of newly diagnosed HIV
infections rose 10% in the 12 months to the end of 2012 – the largest increase
in 20 years.^2 The number of infections diagnosed in 2013 remains at a 20-year
high and represents a 70% increase over the number detected in 1999, when
diagnoses were at their lowest.^3

The TGA Conformity Assessment Certification was achieved after examination by
TGA of the evidence of conformity of the VivaGel^® condom to the Essential
Principles for medical devices, which set out the requirements relating to the
safety and performance of products.

Starpharma has a licensing agreement that provides marketing rights to Ansell
for the VivaGel^® condom in countries outside of Japan. In Japan Starpharma
has licensed the product to Okamoto Industries, Inc. Okamoto is Japan’s
leading marketer of condoms with approximately 60% of the Japanese condom
market, the second largest global market next to the US.

Achievement of this regulatory milestone for the VivaGel^® condom follows
Starpharma’s announcement in March 2014 of regulatory certification of the
VivaGel^® condom in Japan. Regulatory processes are ongoing in a number of
other markets and this TGA approval will support some of these.


LifeStyles Dual Protect™ is a trademark of Ansell
VivaGel^® is a registered trademark of Starpharma

     The Kirby Institute. HIV, viral hepatitis and sexually transmissible
^2   infections in Australia – Annual Surveillance Report 2013. The Kirby
     Institute, The University of New South Wales.
     The Kirby Institute. HIV, viral hepatitis and sexually transmissible
^3   infections in Australia – Annual Surveillance Report 2014. The Kirby
     Institute, The University of New South Wales.


Buchan Consulting
Rebecca Wilson, +61 417 382 391
Tahlia Weston, +61 3 9866 4722
Dr Jackie Fairley, +61 3 8532 2704
Chief Executive Officer
Nigel Baade
CFO and Company Secretary
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