Melbourne, Australia; Starpharma (ASX: SPL, OTCQX: SPHRY) today announced the granting of a patent by the US Patent Office for VivaGel^® related to the prevention of recurrence of bacterial vaginosis (BV). The patent’s term is to 2032 providing an extension of seven years over granted VivaGel^® patents. Additional term may also be available subject to timing of regulatory approval.

This US patent builds on the company’s VivaGel^® patent portfolio that underpins the VivaGel^® BV products. The VivaGel^® patent portfolio comprises granted patents in key markets, including in Europe where the product recently received marketing approval for the topical treatment and rapid relief of BV, including symptomatic relief of vaginal odour and discharge. 

The current market for the management of BV and associated symptoms is estimated to be in excess of US$1 billion globally, with significant areas of unmet need for BV sufferers, especially women with recurrent BV. 

Bacterial vaginosis is the most common vaginal infection worldwide affecting millions of women annually. It is associated with an increased risk of pre-term births, miscarriage, and transmission and acquisition of STIs, including genital herpes and HIV/AIDS. 

Recurrence of BV has been estimated to occur in around 60% of women treated for BV, and there is currently no approved therapy available for prevention. As well as being an effective treatment for the relief of BV symptoms, ongoing use of VivaGel^® BV was shown in a phase 2 clinical study to reduce recurrence of BV. A phase 3 clinical trial programme for VivaGel^® BV for prevention of recurrent BV is progressing well in North America, Europe and Asia.

Discussions regarding commercial rights for VivaGel^® BV are underway with a number of potential partners.  This patent grant will extend the value of this product opportunity for both Starpharma and its partners. 

Starpharma Chief Executive, Dr Jackie Fairley, commented: “The grant of this new patent is confirmation of the innovation that VivaGel^® brings to the bacterial vaginosis field. The patent is one of several in the VivaGel^® portfolio and further enhances the commercial value of VivaGel^® BV.”

Download ASX Announcement: Additional US Patent Granted for VivaGel BV (pdf file, 122kb)