Launch of VivaGel condoms delayed in Japan
Starpharma (ASX:SPL) has announced that the launch of VivaGel coated condoms in Japan will be delayed pending a review by Japanese regulators.
The company’s commercial partner in Japan, Okamoto Industries, has been informed that regulators are reviewing the specific device classification of the condom, which was certified earlier this year.
The review relates to recent changes to Japan’s medical device regulations, and the condoms cannot be sold in Japan until the process is complete.
Starpharma has estimated that the market launch in Japan will be delayed by at least 3-6 months as a result of the review.
“Whilst we are disappointed and surprised with the need to review the classification of our VivaGel condom in the Japanese market, we are working closely with Okamoto and the authorities to expedite this process,” Starpharma CEO Dr Jackie Fairley said.
“This is a matter of regulatory classification in one market and there is no indication of concern with the product itself.”
VivaGel condoms produced by Ansell launched in Australia in October and were approved for sale in New Zealand earlier this month.
Starpharma (ASX:SPL) shares were trading 2.88% lower at $0.505 as of around 1 pm on Friday.
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