Jul 09, 2018

VivaGel® BV NDA advances to next stage of FDA review

VivaGel® BV NDA advances to next stage of FDA review
  • VivaGel® BV NDA advances to next stage of the US FDA review, following completion of the filing review with no issues identified 
  • FDA confirms acceptance of the VivaGel® BV NDA and priority review for both indications
  • VivaGel® BV is already licensed in the majority of territories; negotiations for a North American licence are well advanced

Melbourne, Australia; 9 July 2018: Starpharma (ASX: SPL, OTCQX: SPHRY) today announced that the US FDA has completed its filing review of the VivaGel® BV New Drug Application (NDA), with no issues identified, and confirmed its progress to the next stage.

Confirmation by the FDA that the NDA has been accepted for filing is a significant regulatory milestone for Starpharma. This achievement reflects the completeness of the VivaGel® BV data package and is expected to positively impact on licensing for the North American region, which is in the advanced stages of negotiation.

The FDA has confirmed that the VivaGel® BV NDA will be the subject of a priority review, which has a target review period of approximately 6 months from acceptance.

Dr Jackie Fairley, Starpharma CEO, commented: “We are extremely pleased to have achieved FDA’s acceptance and confirmation that the substantive review is now in progress. This is an important achievement for Starpharma and creates significant commercial value. It’s timely from a licensing perspective as this milestone will positively impact the advanced negotiations currently underway for the North American region – and we look forward to making an announcement shortly.”

VivaGel® BV was granted QIDP and Fast Track status by the FDA – these priority designations are designed to make new therapeutics available to patients as rapidly as possible, carrying significant benefits for regulatory approval and commercialisation of VivaGel® BV.

Fast Track Status has accelerated the regulatory process for VivaGel® BV and is intended to provide early market access for products that address unmet medical needs. QIDP designation was created by the Generating Antibiotic Incentives Now (GAIN) Act and provides incentives for the development of new antimicrobial products. These incentives include priority regulatory review and an additional five years’ of market exclusivity.

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 experiencing repeated episodes. BV is caused by an imbalance of naturally occurring bacterial flora (the usual bacteria found in a woman's vagina). Current therapies for BV are inadequate and have many unpleasant side-effects, there are also no approved products in the US for preventing recurrent BV, making VivaGel® BV a first-in-class therapy for this condition.

Download ASX Announcement: VivaGel® BV NDA advances to next stage of FDA review (PDF 120kb) 

 This contains certain forward-looking statements.