Melbourne, Australia; 19 February 2024: Starpharma (ASX: SPL, OTCQX: SPHRY) today announces that it has completed the formal dispute resolution process with the US Food and Drug Administration (FDA) in relation to VivaGel^® BV. The FDA has maintained its position that they require additional clinical efficacy data to be generated for the regulatory approval of VivaGel^® BV for bacterial vaginosis (BV) in the US. The formal dispute resolution process involved multiple submissions, meetings, detailed analyses, and the preparation of regulatory precedents relating to recent product approvals. Starpharma was supported through this process by highly experienced regulatory advisers, key opinion leaders, and biostatistical and legal advisers, including several who were ex-FDA.

VivaGel^® BV is approved in more than 45 countries globally for both treatment and prevention of BV, including the UK, Europe, Southeast Asia, Australia and New Zealand. Starpharma’s dual strategy, in response to the FDA’s original complete response to the New Drug Application (NDA), involved pursuing formal dispute resolution and considering the need to generate additional clinical data. Starpharma and its clinical and regulatory advisers maintain that the existing clinical data show extensive and robust evidence for the clinical benefit of VivaGel^® BV for the treatment and prevention of BV. The FDA raised no approvability issues with the safety, toxicology, manufacturing or quality aspects of VivaGel^® BV.

Currently, the VivaGel^® BV NDA remains open (Fast Track and QIDP status); however, Starpharma is not planning to pursue additional clinical studies for VivaGel^® BV on its own at this time. Starpharma remains committed to leveraging the VivaGel^® BV development program and will work to maximise the commercial opportunities for VivaGel^® BV in the more than 45 markets where it is already approved. The decision by the FDA does not alter the approval status in the countries where VivaGel^® BV is already registered.  

Starpharma’s Chief Executive Officer, Cheryl Maley, commented: “Naturally, this is not the outcome Starpharma was hoping for. Throughout the dispute resolution process with the FDA, Starpharma has carefully considered and taken account of numerous factors that could affect the outcome of the appeal, including complex regulatory and legal advice, a constantly evolving regulatory landscape, and relatively recent approvals of products used as regulatory precedents.

“VivaGel^® BV has achieved approval in more than 45 other countries and has been launched in multiple markets, including Australia, where the product is the top-selling topical BV treatment. The Company’s more immediate focus is on growing the product’s sales in countries where it is already approved.

“Whilst we explore opportunities to enter the US market in the future, Starpharma will not prioritise conducting another VivaGel^® BV clinical trial. The Company’s primary focus remains on the commercialisation of the clinical-stage DEP^® candidates, our partnerships, and advancing the application of DEP^® in high-value novel therapeutic areas, such as DEP^® antibody-drug conjugates (ADCs) and DEP^® radiotheranostics.”

View/download the ASX Announcement: VivaGel® BV US FDA Appeal Outcome.