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Saturday, August 02, 2014 6:42:21 AM
Tech & Pharma
August 1, 2014
The first of its kind, the VivaGel® condom incorporates an antiviral compound to reduce the risk of exposure to viruses such as HIV, HSV and HPV
AsianScientist (Aug. 1, 2014) – Starpharma has received 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 Europe.
Starpharma’s marketing partner, Ansell, 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.
The VivaGel® condom is the only condom of its type, providing barrier protection and incorporating a proprietary antiviral compound (VivaGel®) in the lubricant, which contains 0.5% astodrimer sodium. 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 percent of HIV (human immunodeficiency virus), HSV (herpes simplex virus) and HPV (human papillomavirus).
Extensive international consumer research conducted in condom users confirms a high level of consumer interest in the VivaGel® condom concept with more than 80 percent of participants surveyed rating the product as very interesting and more than 90 percent indicating they would buy it.
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 percent of the Japanese condom market, the second largest global market next to the US.
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.
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.
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Source: Starpharma; Photo: Victor/Flickr/CC.
Disclaimer: This article does not necessarily reflect the views of AsianScientist or its staff.
http://www.asianscientist.com/tech-pharma/starpharma-launch-anti-viral-condoms-2014/
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