- VivaGel® BV has received a further regulatory approval in Asia
- Mundipharma will market VivaGel® BV under their brand name BETADINETM BV Gel in Asian countries
- This additional approval will facilitate regulatory activities across the region
- Launch of BETADINETM BV Gel in Asia is expected in the coming months
- Further regulatory activities and launch preparations are underway for other countries across Mundipharma regions, including the rest of Asia
Melbourne, Australia; 3 September 2019: Starpharma (ASX: SPL, OTCQX: SPHRY) today announced that it has received a further regulatory approval in an Asian country for VivaGel® BV. This approval follows multiple country approvals in the region as previously announced on 15 August 2019. 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 BETADINETM. BETADINETM BV Gel will be available Over-The-Counter (OTC) in 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.
In addition to these approvals, Starpharma and Mundipharma have submitted further regulatory submissions in countries across Asia and other Mundipharma regions. This approval, and the previous announced approvals, will facilitate and accelerate further registrations in Asia.
Dr Jackie Fairley, Starpharma CEO, commented: “We are very pleased to achieve momentum with these approvals for VivaGel® BV in Asia. We are working closely with Mundipharma to achieve approvals throughout the region and look forward to providing this breakthrough product for BV to patients in Asia”.
Raman Singh, Mundipharma CEO, commented: “This is another important step in our efforts to establish BETADINETM BV Gel as the category leader in Asia for the management of bacterial vaginosis (BV) as part of the successful Betadine brand portfolio in the coming months.”
The specific countries which have been granted regulatory approval in Asia currently remain undisclosed at this time for competitive reasons.
About VivaGel® BV
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.
Starpharma Holdings Limited (ASX: SPL, OTCQX:SPHRY), located in Melbourne Australia, is an ASX 300 company and is a world leader in the development of dendrimer products for pharmaceutical, life science and other applications.
Starpharma’s underlying technology is built around dendrimers – a type of synthetic nanoscale polymer that is highly regular in size and structure and well suited to pharmaceutical and medical uses. Starpharma has two core development programs: VivaGel® portfolio and DEP® drug delivery with the Company developing several products internally and others via commercial partnerships.
VivaGel®: Starpharma’s women’s health product – VivaGel® BV is based on SPL7013, astodrimer sodium, a proprietary dendrimer. VivaGel® BV for bacterial vaginosis (BV), is available for sale under the brand name Betadine BVTM (Europe) and Fleurstat BVgel (Australia) and a new drug application has been submitted to the US FDA. Starpharma has licensed the sales and marketing of VivaGel® BV to ITF Pharma for the US; Mundipharma for Europe, Russia, CIS, Asia, the Middle East, Africa and Latin America; and to Aspen Pharmacare for Australia and New Zealand. Starpharma also has licence agreements to market the VivaGel® condom (an antiviral condom which includes VivaGel® in the lubricant) in several regions, including Australia, Europe, Canada, China and Japan (Okamoto). The VivaGel® condom has been launched in Japan under Okamoto’s 003 brand, and in Australia and Canada under the Lifestyles® Dual ProtectTM brand.
DEP® – Dendrimer Enhanced Product®: Starpharma’s DEP® drug delivery platform has demonstrated reproducible preclinical benefits across multiple internal and partnered DEP® programs, including improved efficacy, safety and survival. Starpharma has three internal DEP® products – DEP® docetaxel, DEP® cabazitaxel and DEP® irinotecan – in clinical development in patients with solid tumours. Starpharma’s partnered DEP® programs include a multiproduct DEP® licence with AstraZeneca, which involves the development and commercialisation of two novel oncology compounds, with potential to add more. In June 2019 Starpharma signed a Development and Option agreement with AstraZeneca for a DEP® version of one of AstraZeneca’s major marketed oncology medicines.
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