Starpharma has completed the VivaGel BV rolling submission to the FDA for treatment of bacterial vaginosis.

The module, which was submitted to the FDA under Starpharma’s rolling submission on Friday 22 December 2017 (US time), is the fourth of five modules to be submitted and accounts for a major part of the overall submission. The FDA has also completed a preliminary review of the proposed clinical datasets and has confirmed that the intended format and presentation of that data is acceptable.

Included in the BV treatment section is data from Starpharma’s two phase III treatment clinical trials of VivaGel BV conducted in 2012. Efficacy data from these trials complies with the revised FDA guidance for the treatment of bacterial vaginosis (BV) issued in mid-2016. The revised FDA guidance recommends that the primary efficacy endpoint for products for treatment of BV should be assessed 7–14 days after commencing treatment. This timing aligns with the data from Starpharma’s 2012 BV treatment efficacy trials, which showed highly statistically significant clinical cure of BV when patients were assessed 2–5 days after end of treatment (9?12 days after commencing treatment).

Starpharma’s NDA submission for VivaGel BV is for both BV indications - BV treatment and prevention of recurrent BV (rBV). As previously announced, the first three of five modules of the NDA were submitted in November, and it is expected that the final clinical data and remaining module will be submitted in the near future. Based on experience with other products granted Fast Track status, review time is expected to be approximately 6-8 months. The VivaGel BV NDA submission and review process benefits from FDA’s Fast Track status and Qualified Infectious Disease Product (QIDP) designation which are designed to accelerate the regulatory process and secure rapid approval and early market access for products that address unmet medical needs.

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 in the near future. Starpharma is actively engaged in licensing negotiations for commercial rights to VivaGel BV across multiple regions. A number of term sheets and draft contracts are currently under discussion with parties, including major global and regional companies as well as companies specialising in women's health. These negotiations have been impacted positively by Fast Track status and QIDP designation, successful phase III rBV results and most recently, TGA approval, which is also relevant for many markets outside Australia.