Starpharma (ASX:SPL) has announced it has received, overnight, marketing approval in the European Union (EU) for VivaGel BV for the treatment and rapid relief of bacterial vaginosis (BV) including symptoms.
The approval allows for the marketing of VivaGel BV in the European Economic Area (EEA), which includes the 28 countries of the EU plus the European Free Trade Association (EFTA) countries, providing access to a population of more than 260 million women. In addition, the EU approval will be used as the basis for obtaining what the company said is expected to be relatively rapid regulatory and marketing approvals for VivaGel BV in a number of other countries that formally recognise the EU approval.
According to the company bacterial vaginosis is the most common vaginal infection worldwide. It is associated with an increased risk of pre-term births, miscarriage, and transmission and acquisition of STIs, including genital herpes and HIV/AIDS.
Starpharma Chief Executive, Dr Jackie Fairley, said, “The marketing approval for VivaGel BV in the EU is a very significant milestone both for Starpharma and the VivaGel portfolio. It opens up a large and important market for the product and we expect this approval to expedite commercial discussions already underway. In addition, the EU approval will be used as the basis of additional regulatory approvals for VivaGel BV in regions that rely on the European approval. We will be actively pursuing these two priorities in parallel.”
In clinical trials, VivaGel BV, when used once daily for seven days, demonstrated significant benefits over a placebo in the treatment of BV in women.
VivaGel BV is a unique topical vaginal gel. The proprietary dendrimer active is not absorbed systemically following topical application, and acts locally to suppress the pathogens that cause BV and the associated signs and symptoms. VivaGel BV is easy to use, and in clinical trials was associated with very low rates of candidiasis (2-3 per cent), which is a significant secondary complication of other therapy options, for which rates of up to 30 per cent have been reported.
The company said discussions regarding marketing rights for VivaGel BV are already underway with a number of potential commercial partners and are expected to be facilitated by the EU approval.