First Asian Regulatory Approvals Received for VivaGel® BV

August 15, 2019 - 9 minutes read
  • 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; 15 August 2019: Starpharma (ASX: SPL, OTCQX: SPHRY) 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 BETADINETM. 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 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.

 

About Starpharma

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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For further information, please contact:
Media WE Buchan Consulting

Rebecca Wilson
Mob: +61 417 382 391
rwilson@buchanwe.com.au

Arthur Chan
+61 2 9237 2805
achan@buchanwe.com.au

Starpharma

Dr Jackie Fairley, Chief Executive Officer
Nigel Baade, CFO and Company Secretary
+61 3 8532 2704
investor.relations@starpharma.com

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