Aug 15, 2019
First Asian Regulatory Approvals Received for VivaGel® BV
- VivaGel® BV has received regulatory approval in South East Asian countries, with further registration reviews at an advanced stage throughout the region
- Mundipharma will market VivaGel® BV under their brand name BETADINETM BV Gel
- Launch of BETADINETM BV Gel in Asia is expected in the coming months
- Approval triggers first Asian regulatory milestone to Starpharma
- Further regulatory activities and launch preparations are underway for other countries across Mundipharma regions, including the rest of Asia
Melbourne, Australia: Starpharma today announced that it has received the first regulatory approvals in South East Asia for VivaGel® BV. Mundipharma will be rolling-out the product in Asia under the brand name BETADINETM BV Gel.
BETADINETM BV Gel will be marketed by Mundipharma, a leading global pharmaceutical company which owns the successful international brand BETADINE™. BETADINETM BV Gel will be available Over-The-Counter (OTC) in South East Asia. The launch of BETADINETM BV Gel in Asia is expected to occur in the coming months and follows other launches of VivaGel® BV in Europe and Australia earlier this year.
Starpharma and Mundipharma have submitted further regulatory submissions in countries across Asia and other Mundipharma regions.
VivaGel® BV is a novel, 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.
BV is a troublesome and often recurrent condition that causes unpleasant vaginal odour and discharge symptoms that have significant social impact for women. BV has also been associated with a range of other serious reproductive health-related medical problems.
Dr Jackie Fairley, Starpharma CEO, commented: “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”.
Raman Singh, Mundipharma CEO, commented: “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). We are working closely with Starpharma to secure further approvals and look forward to launching BETADINETM BV Gel and to extending our line of feminine care products in Asia.”
One of these initial regulatory approvals triggers a small milestone payment to Starpharma under Mundipharma’s licence with further milestones payable for other key countries. Starpharma is eligible to earn total milestones up to US$24.7M, plus revenue share, for all territories under Mundipharma’s licence.
Download ASX Announcement: First Asian Regulatory Approvals Received for VivaGel® BV (PDF, 62kb)