Melbourne, Australia; Starpharma Holdings Ltd (ASX: SPL, OTCQX: SPHRY) today announced that the planned launch timing of the VivaGel^® condom in Japan would be delayed following a review of the specific category of medical device classification by the Japanese regulatory authorities.

The regulatory status of the VivaGel^® condom in other regions where the product is approved for sale (Australia and New Zealand) or is undergoing regulatory review is not affected and does not rely upon the Japanese classification or approval process.

Since receiving regulatory certification for the VivaGel^® condom in Japan earlier this year, Starpharma’s commercial partner, Okamoto Industries (Okamoto), has been actively undertaking launch preparations for the product with a view to launching the product shortly.  In the context of pre-launch labelling discussions and against a background of recent changes to medical device regulations in Japan, the parties have been informed by the Japanese regulatory authorities that they are reviewing the specific device classification of the VivaGel^® condom. The product cannot be sold in Japan until the review process is complete.  

Starpharma and Okamoto are working closely with Japan’s Ministry of Health, Labour and Welfare (MHLW) to confirm the classification as soon as possible. At this time, Starpharma cannot be certain about the precise extent of the delay in the Japanese market launch but estimate it to be at least 3-6 months.

Starpharma CEO, Dr Jackie Fairley, said, “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.  This is a matter of regulatory classification in one market and there is no indication of concern with the product itself.

“Last week the MHLW introduced significant changes to medical device regulations in Japan. These include changes to the regulatory bodies that approve certain categories of medical devices and the associated regulatory processes in Japan, and it appears that these changes may have influenced this situation.”

VivaGel^® condoms are already on sale in Australia and approved for sale in New Zealand. Regulatory processes are underway in a number of other markets and will continue in parallel with, and are not impacted in any way by, the review of the classification status in Japan.

The VivaGel^® condom is one of three products in Starpharma’s VivaGel^® portfolio, with the other two in late stage development for the management of bacterial vaginosis (BV). Regulatory files for the BV Symptomatic Relief product will be submitted in the near future and this re-classification is not relevant to that product or the Phase 3 trials for prevention of recurrent BV, which are progressing well. 

About VivaGel®

Starpharma’s VivaGel^® has both antibacterial and antiviral properties and has been shown in laboratory studies to inactivate up to 99.9% of HIV, Herpes and HPV, which are common viruses that cause STIs. The VivaGel^® condom incorporates VivaGel^® in the condom lubricant.

VivaGel^® is also in late stage development as a vaginal gel formulation for the management of bacterial vaginosis.

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