Apr 11, 2019

Starpharma meets with US FDA to discuss VivaGel® BV

Starpharma meets with US FDA to discuss VivaGel® BV

Melbourne, Australia; 11 April 2019: Starpharma (ASX: SPL, OTCQX: SPHRY) today announced that a meeting was held with the US FDA overnight as part of the process to clarify and address FDA’s request for confirmatory data prior to the approval of VivaGel® BV in the US. This meeting was attended by senior representatives of Starpharma as well as internationally recognised Key Opinion Leaders in BV, statisticians and the Company’s expert FDA regulatory consultants, which include former senior FDA clinical personnel. 

Prior to the meeting, Starpharma submitted a comprehensive package of information to the FDA, including additional statistical analyses of existing data on VivaGel® BV, which was prepared in response to the FDA’s request, and to provide further support for the approval of VivaGel® BV. The submission was prepared with input from Starpharma’s team of expert FDA consultants and statisticians.

Commenting on the meeting, Starpharma CEO Dr Jackie Fairley said: “This was an important step to better understand and address the FDA’s feedback – it was a constructive and interactive meeting and we were very pleased with the level of engagement by the FDA in the discussions”.

Starpharma appreciates that the outcome of this FDA process is of particular interest to shareholders and expects to be able to provide further information once formal outcomes of the FDA meeting and the subsequent follow up has been confirmed in writing by the FDA.

“VivaGel® BV is already approved and will soon be launched in Europe and Australia with regulatory submissions underway for other regions. We look forward to working with the FDA to enable this important product to also be available to BV sufferers in the US”, concluded Dr Fairley.  

Download ASX Announcement: Starpharma meets with US FDA to discuss VivaGel® BV (PDF 113KB)

 This contains certain forward-looking statements.