Starpharma submits final VivaGel BV module to FDA

Latest News

Starpharma (ASX:SPL) has announced that its rolling new drug application (NDA) for VivaGel BV including two indications, for the treatment of bacterial vaginosis (BV) and prevention of BV, has been completed, and the final module of the NDA will be submitted to the US FDA.

The review of the VivaGel BV NDA by the FDA has already commenced and will be conducted as a priority review based on the Fast Track status of the product. The NDA review is expected to take approximately 6-8 months from the completed submission, said the company.

Fast Track status is intended to accelerate the regulatory process and secure rapid approval and early market access for products that address unmet medical needs. VivaGel BV was also granted Qualified Infectious Disease Product (QIDP) designation, which applies to certain important new antibacterial products. As well as making the product eligible for Fast Track status, QIDP designation provides other significant commercial advantages such as an additional five years market exclusivity.

Starpharma said it also has a Special Protocol Agreement in place from the FDA for VivaGel BV which provides binding FDA agreement on the phase 3 trial design.

The company said VivaGel BV offers the potential to fill a currently unmet medical need with respect to both the treatment and prevention of BV.

"Compared with existing therapies, none of which are approved for prevention of BV, VivaGel BV is characterised by an absence of problematic drug interactions, an absence of need for food or alcohol restrictions, reduced risk of side effects, and a lack of effect in promoting harmful antibiotic resistance," said the company.

"VivaGel BV acts via a novel mechanism of action, whereby it affects BV-related biofilms, which have been linked to persistence and recurrence of the condition. The product is well suited to longer-term use, given the lack of absorption of the product into the bloodstream and resulting lack of systemic side effects attributable to the product."

According to Dr Jackie Fairley, Starpharma CEO, “Completion of our NDA filing is an exciting milestone for Starpharma, and a great story for Australian innovation. We look forward to VivaGel BV being available for patients in the US, where the rate of BV is particularly high, with one in three women suffering from this troubling and recurring condition. In parallel with these regulatory activities, Starpharma’s licensing negotiations for commercial rights to VivaGel BV are now well-advanced across multiple regions, including the US. Draft contracts are currently under advanced negotiation with parties, including major global and regional companies as well as companies specialising in women's health."

VivaGel BV is already approved for sale in Europe and Australia. In Australia, VivaGel BV is licensed to Aspen Pharmacare, who will launch the product under the Fleurstat brand in the near future.