Overview of Starpharma's FDA appeal outcome

Starpharma (ASX: $SPL) has concluded the formal dispute resolution process with the US Food and Drug Administration (FDA) regarding VivaGel® BV. The FDA has upheld its requirement for additional clinical efficacy data for the regulatory approval of VivaGel® BV for bacterial vaginosis (BV) in the US. The company's dual strategy involved pursuing formal dispute resolution and considering the need for additional clinical data, while maintaining its commitment to leveraging the VivaGel® BV development program and maximizing commercial opportunities in the markets where it is already approved.

Executive commentary on FDA appeal outcome

Starpharma's Chief Executive Officer, Cheryl Maley, expressed disappointment with the FDA's decision, emphasizing the extensive and robust evidence for the clinical benefit of VivaGel® BV. While the focus remains on growing the product's sales in approved markets, the company will not prioritize conducting another VivaGel® BV clinical trial at this time. Instead, Starpharma will concentrate on commercializing the clinical-stage DEP® candidates, partnerships, and advancing the application of DEP® in high-value novel therapeutic areas.

Summary of FDA appeal outcome and future outlook

The FDA's maintenance of the requirement for additional clinical efficacy data for VivaGel® BV in the US has led Starpharma to shift its focus towards maximizing commercial opportunities in the more than 45 markets where the product is already approved. While the VivaGel® BV NDA remains open, the company does not plan to pursue additional clinical studies for VivaGel® BV independently at this time. Starpharma remains committed to leveraging the VivaGel® BV development program and exploring opportunities to enter the US market in the future. Additionally, the company will prioritize the commercialization of the clinical-stage DEP® candidates and the advancement of DEP® in high-value novel therapeutic areas, such as DEP® antibody-drug conjugates (ADCs) and DEP® radiotheranostics.