VivaGel® Condom Receives Final Regulatory Approval in Japan

MELBOURNE, Australia–(BUSINESS WIRE)–Starpharma (ASX: SPL, OTCQX: SPHRY) today announced that the VivaGel®
condom has received final regulatory approval and is now able to be
marketed in Japan, following the completion of the Japanese
Pharmaceuticals and Medical Devices Agency (PMDA) review of the
product’s medical device classification and associated data. This final
approval follows on from the previously granted regulatory
certification, which was attained for the VivaGel® condom.

Starpharma has worked closely with its commercial partner for Japan,
Okamoto Industries (Okamoto), throughout the regulatory process. Okamoto
has already commenced key launch preparations, including labelling and
manufacturing activities, and plans to launch the VivaGel®
condom in the first half of 2019. Starpharma will be eligible to receive
royalty payments under its licence with Okamoto.

Okamoto is Japan’s leading marketer of condoms with a majority share of
the Japanese condom market, which is one of the world’s largest condom
markets and estimated to be in the order of US$500 million per annum1.
Okamoto has sales revenue of more than US$1.1 billion and around 2,600
employees. In addition to its dominant position in the Japanese condom
market, Okamoto also holds strong market positions in several other
Asian markets, including Korea, Taiwan, Malaysia, Singapore and China.

Starpharma Chief Executive Officer, Dr Jackie Fairley, said, “This
regulatory achievement marks a key commercial milestone for the VivaGel®
condom, particularly given the significant value of the Japanese condom
market and our partner’s leading market position. Okamoto has an
outstanding product portfolio and heritage in the successful
commercialisation of new products and we’re very excited to soon see
VivaGel® condoms for sale in Japan.”

Okamoto’s senior managing director, Mr. Keiji Ikeda, has noted that
condoms with functional coatings and gels represent the next wave of
innovation in the Japanese condom market following on from a previous
focus on condom thinness. Mr. Ikeda said, “We are very pleased to be in
a partnership with Starpharma for this innovative product and excited
about its upcoming launch.”

The VivaGel® condom is also approved for sale in Australia
and Canada, and further regulatory reviews continue in a number of other
geographic regions.

About the VivaGel® condom

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.
VivaGel® has
been proven in laboratory studies to inactivate up to 99.9% of HIV, HSV
and HPV.

1 Market Data Bank (MDB) Report issued February 2009,
Condoms: A Global Strategic Business Report and Industry Data

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