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Starpharma Says VivaGel Condom Gets Final Regulatory Approval In Japan

Australian biotech company Starpharma Holdings Ltd. (SPHRY.OB) announced that the VivaGel condom has received final regulatory approval and is now able to be marketed in Japan.

The approval is following the completion of the Japanese Pharmaceuticals and Medical Devices Agency or 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, 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.

The VivaGel condom is based on innovative Australian technology. It is the only condom of its type, providing barrier protection and incorporating the proprietary compound, astodrimer sodium in the condom lubricant.VivaGel has been proven in laboratory studies to inactivate up to 99.9% of HIV, HSV and HPV.

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

In Australia, Starpharma shares declined 10.6 percent on Wednesday to A$1.06.

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