Starpharma announces first regulatory approval in Asia for VivaGel BV

Latest News

Starpharma (ASX:SPL) says it has received the first regulatory approvals in South East Asia for VivaGel BV.

The company said its partner Mundipharma will be rolling out the product in Asia under the brand name BETADINE BV Gel. It will be available Over-The-Counter (OTC) in South East Asia with the launch expected to occur in the coming months.

Starpharma and Mundipharma have submitted further regulatory submissions in countries across Asia and other Mundipharma regions.

VivaGel BV is a non-antibiotic therapy for the treatment of bacterial vaginosis (BV) and prevention of recurrent BV.

BV is the most common vaginal condition worldwide and twice as common as thrush. One in three women will experience BV and half of these women will have recurrent BV. VivaGel BV is an Australian innovation – invented, fully developed and taken through to commercialisation by Starpharma.

According to Starpharma CEO, Dr Jackie Fairley, “We are very pleased to receive our first regulatory approvals of VivaGel BV in Asia. These approvals will positively impact further regulatory activities across the region and Starpharma continues to work closely with Mundipharma to secure approvals and achieve market launch as quickly as possible. BV is a troublesome condition for women around the world and we’re delighted that this breakthrough product will soon be available to patients in Asia,”

“I am very delighted that we have our first regulatory approvals in Asia to introduce this true innovation in the management of bacterial vaginosis (BV)," said Raman Singh, Mundipharma CEO.

"We are working closely with Starpharma to secure further approvals and look forward to launching BETADINE BV Gel and to extending our line of feminine care products in Asia.”

Starpharma said one of these initial regulatory approvals triggers a small milestone payment under Mundipharma’s licence with further milestones payable for other key countries. Starpharma is eligible to earn total milestones up to US$24.7 million, plus revenue share, for all territories under Mundipharma’s licence.