Melbourne, Australia: Starpharma (ASX: SPL, OTCQX: SPHRY) today announced that its US New Drug Application (NDA) submission for VivaGel^® BV for both treatment and prevention of BV has been lodged with the FDA through a rolling submission process.

VivaGel^® BV has been granted Fast Track status and Qualified Infectious Disease Product (QIDP) designation, which allows for rolling submission of the NDA and ensures priority regulatory review by the FDA.

FDA Fast Track status is designed to accelerate the regulatory process and secure rapid approval and early market access for products that address unmet medical needs. The QIDP designation applies to certain new antibacterial products and provides other significant commercial advantages such as an additional five years’ market exclusivity.

The rolling NDA submission for VivaGel^® BV is for both BV indications - BV treatment and prevention of recurrent BV (rBV). The NDA will feature data from the phase 3 trials for rBV reported in August 2017, as well as earlier trial data on BV treatment. The complete NDA will comprise five main data modules. The current submission includes three of the five main modules. Further modules are currently being finalised and will be submitted in the near future and then FDA review is expected to take approximately 6-8 months.

In parallel with these regulatory activities, Starpharma is currently actively engaged in both global and regional negotiations for commercial rights to VivaGel^® BV, with a number of term sheets under discussion, and facilitated by a leading global healthcare investment bank. Filing of the NDA is an important milestone for the commercialisation of the product and, together with the benefits of Fast Track priority review and QIDP designation, this achievement will impact positively on commercial negotiations.

Dr Jackie Fairley, Starpharma CEO, commented: “We are delighted to be submitting our NDA for VivaGel^® BV. Starpharma is one of very few Australian companies to have achieved an NDA submission. It is very satisfying strategically that we have retained the commercial rights to VivaGel^® BV, while developing the product from discovery through to the successful phase 3 trials and NDA submission – in doing so we’ve maximised its commercial value.”

About VivaGel^® BV 

VivaGel^® BV is a patented, water-based vaginal gel for the treatment of bacterial vaginosis (BV) and prevention of recurrent BV. VivaGel^® BV is a breakthrough product which specifically targets the organisms that cause BV, rapidly relieves symptoms and has a novel mechanism of action affecting biofilm. VivaGel^® BV is a non-antibiotic therapy and is not absorbed into the bloodstream.

VivaGel^® BV is protected by patents in the US and elsewhere with coverage out to 2032. VivaGel^® BV demonstrated compelling efficacy in phase 3 trials without the unpleasant side effects of current BV therapies and has been endorsed by clinicians and patients alike. VivaGel^® BV is already approved in Europe and Australia and is expected to be first available in Australian pharmacies, under the brand name Fleurstat™ in 2018.  

About Bacterial Vaginosis (BV)

Bacterial vaginosis is the most common cause of vaginal infection for women of childbearing age, and affects around 30% of women in the US. It is a highly recurrent condition with 50-60% of sufferers having it recurrently. BV is caused by an imbalance of naturally occurring bacterial flora (the usual bacteria found in a woman's vagina). Smoking, the use of some hygiene products and several other risk factors are linked to a higher risk of developing BV. Current therapies for BV are inadequate and have many unpleasant side-effects, there are also no approved products in the US for rBV making VivaGel^® BV a first-in-class therapy supported by large, randomised clinical studies. 

Download ASX Announcement: NDA submission for VivaGel® BV in the US (pdf file, 160kb)