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Biopharmaceuticals Regulatory

 News Release - September 24, 2015

EU Marketing Approval Granted for VivaGel(R) BV

MELBOURNE, Australia--(Healthcare Sales & Marketing Network)--Starpharma (SPL.AX) (SPHRY) today 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 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.

Bacterial vaginosis is the most common vaginal infection worldwide. It is the most common cause of abnormal vaginal discharge and unpleasant vaginal odour in women and is associated with an increased risk of pre-term births, miscarriage, and transmission and acquisition of STIs, including genital herpes and HIV/AIDS.

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. A key benefit of VivaGel® BV in clinical trials was the rapid relief of patients’ symptoms associated with BV, including unpleasant vaginal odour and discharge. In addition, use of VivaGel® BV helped to normalise vaginal pH and suppress the bacteria that cause the vaginal microflora imbalance that characterises BV. In formal market research BV sufferers using VivaGel® BV reported very high levels of overall satisfaction, comfort and ease of use.

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%), which is a significant secondary complication of other therapy options, for which rates of up to 30% have been reported.

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. The current market for the management of BV and associated symptoms is estimated to be in excess of US$750 million globally, with significant areas of unmet need for BV sufferers.

Starpharma Chief Executive, Dr Jackie Fairley, commented: “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.”

The phase 3 clinical trial programme for the VivaGel® BV product for the prevention of recurrent BV is also progressing smoothly in North America, Europe and Asia, and is now well in excess of 50% recruited.

Source: Starpharma

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