TGA approval for Starpharma product

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Starpharma (ASX:SPL) has announced TGA approval for VivaGel BV for the treatment of bacterial vaginosis (BV).

The company said 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. It 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.

VivaGel BV is a patented vaginal gel developed by Starpharma that works rapidly to resolve BV and the associated signs and symptoms.

According to the company, patient and clinician experience with BV indicates current treatment options, such as antibiotics, are lacking in terms of their efficacy and the magnitude of unwanted side-effects.

VivaGel BV's "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."

Starpharma chief executive, Dr Jackie Fairley, said, “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 and 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 said it is pursuing regulatory approval in the US. 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 said it is working with a leading global healthcare investment bank to support the competitive process and finalisation of commercial arrangements for these territories.