Starpharma has reached home base in Japan with its antibacterial condom after passing final regulatory approvals.

The booty call from the Japanese Pharmaceuticals and Medical Devices Agency allows the antibacterial condom to be marketed there.

The VivaGel condom is already approved for sale in Australia and Canada.

“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,” said Starpharma CEO Dr Jackie Fairley.

Starpharma (ASX:SPL) says its local distributor Okamoto has sales revenue of $1.6 billion, which it hopes to increase and take a cut through the sale of the condoms.

US swipes right

But despite Japan’s desire for the product, shares in the sexual health drug developer have continued to mooch lower on the first day of trading in 2019.

That’s because the powerful US Food and Drug Administration (FDA) is asking for more info on Starpharma’s bacterial vaginosis gel before swiping right.

Starpharma was increasingly desirable at the end of 2018 after signing a US licensing deal for its bacterial vaginosis treatment that, it said, would be worth up to $142 million.

But after Christmas they had to reveal that the FDA wanted “confirmatory clinical data” before it would approve VivaGel BV in the country.

The stock immediately plunged fell 37 per cent and continued the fall today, losing another 7 per cent by midday.

Starpharma shares (ASX:SPL) since the FDA announcement.

Dr Fairley will meet with the regulatory body as soon as possible to get clarity on what data it needs, but admitted it was a significant roadblock.

“Clearly we are surprised and extremely disappointed with the FDA’s requirement for confirmatory data in order to approve the NDA for VivaGel BV considering the comprehensive nature of the data provided,” she said.

Starpharma has been contacted for comment.

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