Oct 25, 2017

VivaGel® BV granted marketing approval in Australia

VivaGel® BV granted marketing approval in Australia

Melbourne, Australia; Starpharma (ASX: SPL, OTCQX: SPHRY) today announced it has received Australian marketing approval from the Therapeutic Goods Administration (TGA) for VivaGel® BV, which is intended for treatment of bacterial vaginosis (BV). Launch plans for VivaGel® BV are well advanced and the product is expected to be available in pharmacies in the New Year.


VivaGel® BV, an Australian innovation, was developed by Starpharma and will be marketed in Australia by Aspen Pharmacare as Fleurstat™ BV gel, and will carry the VivaGel® brand. Aspen is responsible for all marketing, promotion and local distribution of the product to clinicians and pharmacies. Starpharma will supply Aspen with the VivaGel® BV product and will also receive royalties on net sales.


The TGA approval is significant not only for the Australian market but also internationally as there are many countries in Asia, the Middle East and South America where marketing approval is largely based on Starpharma’s home-country registration.


VivaGel® BV is a patented vaginal gel developed by Starpharma that works rapidly to resolve BV and the associated signs and symptoms. Patient and clinician experience with BV indicates that current treatment options, such as antibiotics, are lacking in terms of their efficacy and the magnitude of unwanted side-effects. VivaGel® BV is a novel product which provides a new approach to the management of BV. Its proprietary dendrimer active is not absorbed systemically, and acts locally to help restore the normal vaginal flora balance, working quickly to resolve the associated signs and symptoms.  VivaGel® BV is easy to use, and in clinical trials was associated with high levels of patient satisfaction and very low rates of candidiasis (thrush), which is a significant secondary complication of other current antibiotic therapy options. 


Starpharma Chief Executive, Dr Jackie Fairley, commented: “We are delighted that VivaGel® BV has been approved for sale in Australia. There’s a significant need for new, clinically proven therapeutic options for this very common and persistent condition, which is associated with serious medical consequences and problematic symptoms if left untreated. Given the prevalence of antibiotic resistance worldwide, the fact that VivaGel® BV is not a conventional antibiotic makes it a particularly appealing solution for patients and doctors alike.”


“With the upcoming launch of VivaGel® BV, Australian clinicians and pharmacists will soon be able to recommend this novel non‑antibiotic treatment for this common and problematic condition. For Starpharma, it is particularly exciting to launch this Australian innovation into the local market. Aspen is an ideal partner for VivaGel® BV in Australia with a proven track record in women’s health.”


Aspen Australia, Head of Nutritionals & Consumer OTC, Robert Barnes added “Aspen is looking forward to marketing this innovative product in the Australian marketplace.”


VivaGel® BV is also approved in the EU. Starpharma is pursuing regulatory approval in the US, with Starpharma’s marketing application (NDA) to the US Food and Drug Administration (FDA) already well-advanced and expected to be submitted shortly. Regulatory approval is also being pursed in other regions.


Starpharma has licensed the marketing and distribution rights for VivaGel® BV to Aspen for the Australian and New Zealand markets. In the US, Europe and the rest of the world the marketing rights for VivaGel® BV currently rest with Starpharma. The Company is working with a leading global healthcare investment bank to support the competitive process and finalisation of commercial arrangements for these territories.


About Bacterial Vaginosis (BV)

BV is the most common vaginal infection worldwide. BV is the result of a major imbalance in the types and numbers of bacteria in the vagina resulting in a characteristic odour and discharge.


Download ASX Announcement: VivaGel® BV granted marketing approval in Australia ( pdf file, 83kb)

 This contains certain forward-looking statements.