First VivaGel BV launch globally in Australia by Aspen

Melbourne, Australia; 16 April 2019: Starpharma (ASX: SPL, OTCQX: SPHRY) today announced that VivaGel^® BV has been officially launched in Australia by Aspen Pharmacare (Aspen) as Fleurstat BVgel. The product has undergone distribution across Australia and is already available in some pharmacies. It will be progressively rolled-out nationally over the coming weeks. This is the first launch of VivaGel^® BV in the world and further launches by Mundipharma are expected in Europe in May/June this year.

VivaGel^® BV (Fleurstat BVgel) is a novel, non-antibiotic therapy for treatment of bacterial vaginosis (BV) and relief of symptoms. BV is the most common vaginal condition worldwide and twice as common as thrush. VivaGel^® BV (Fleurstat BVgel) is an Australian innovation –invented, fully developed and taken through to commercialisation by Starpharma.

BV is a troublesome and often recurrent condition that causes unpleasant vaginal odour and discharge symptoms that have significant social impacts for women. BV has also been associated with a range of other serious reproductive health-related medical problems. Until now, women have only been able to access antibiotic-based treatments for BV, which are only available by prescription from a GP or specialist.

Fleurstat BVgel is a non-antibiotic therapy and is the only BV treatment available over-the-counter (OTC) at pharmacies, without the need for a prescription. Fleurstat BVgel is being marketed in Australia by Aspen.

Aspen’s sales and marketing activities will include a series of healthcare practitioner and direct to consumer programs.

Dr Jackie Fairley, Starpharma CEO, commented: “We are very pleased to have achieved the important milestone of first launch of VivaGel^® BV in the world, in collaboration with our Australian partner, Aspen. Given this is the first of many launches for this breakthrough BV product globally, this is a very exciting period for the company. VivaGel^® BV, marketed in Australia as Fleurstat BVgel, is a real success story for Australian innovation. It’s exceedingly rare to have a global healthcare product developed by an Australian company all the way from concept to commercialisation, let alone with the first global launch in Australia”.

Rob Barnes, Head of Nutritionals & Consumer OTC, Aspen Australia, commented: “Aspen is proud to be the first company in the world to launch this breakthrough BV product and to make Fleurstat BVgel available to Australian patients. We’re delighted to be associated with such an innovative product, especially seeing as it’s an Australian discovery. This will be the first time Australian women are able to purchase a BV product over-the-counter in pharmacies”.

About VivaGel^® BV

VivaGel^® BV is a patented, water-based vaginal gel containing the dendrimer, astodrimer sodium (SPL7013). VivaGel^® BV has a novel mechanism of action targeting biofilms. It works to treat BV by disrupting the attachment of BV-causing bacteria to the vaginal lining. The original dendrimer technology on which VivaGel^® BV is based was discovered by CSIRO.

VivaGel^® BV is marketed in Australia by Aspen Pharmacare under the brand name, Fleurstat BVgel. Fleurstat BVgel is for the treatment of bacterial vaginosis (BV) and relief from symptoms. Ask your pharmacist – they must decide if the product is right for you. Always read the label. Follow the directions for use. See your doctor if your symptoms persist or recur, or your condition worsens, as these symptoms may be indicative of another infection, including an STI, and if you consider you may be at risk. If you are planning to be or are currently pregnant or breastfeeding, you should seek advice of your doctor before using Fleurstat BVgel.

VivaGel^® BV is a breakthrough product that works rapidly. It is a non-antibiotic therapy and is not absorbed into the bloodstream.

The VivaGel^® BV treatment product targets an area of significant unmet medical need in a high-value market (est. US$750M). VivaGel^® BV is also approved in Europe for treatment and prevention of recurrent BV, and has been submitted to regulatory authorities in a number of international markets, including the US. Prevention of recurrent BV is another high value market (est. US$1B) for VivaGel^® BV.

About Bacterial Vaginosis (BV)

Bacterial vaginosis is the most common vaginal infection worldwide, and twice as common as thrush. It affects around 30% of women in the US. It is a highly recurrent condition with 50-60% of sufferers having it recurrently. BV is caused by an imbalance of naturally occurring bacterial flora (the usual bacteria found in a woman’s vagina). Smoking, the use of some hygiene products and several other risk factors are linked to a higher risk of developing BV. BV has been associated with a range of serious medical problems.

About Starpharma

Starpharma Holdings Limited (ASX: SPL, OTCQX:SPHRY), located in Melbourne Australia, is an ASX 300 company and is a world leader in the development of dendrimer products for pharmaceutical, life science and other applications.

Starpharma’s underlying technology is built around dendrimers – a type of synthetic nanoscale polymer that is highly regular in size and structure and well suited to pharmaceutical and medical uses. Starpharma has two core development programs: VivaGel^® portfolio and DEP^® drug delivery with the Company developing several products internally and others via commercial partnerships.

VivaGel^®: Starpharma’s women’s health product - VivaGel^® BV is based on SPL7013, astodrimer sodium, a proprietary dendrimer. VivaGel^® BV is approved for marketing in the EU for treatment and prevention of bacterial vaginosis (BV) and available for sale in Australia for treatment of BV and relief of symptoms. A marketing application has been submitted to the US FDA. Starpharma has licensed the sales and marketing of VivaGel^® BV to ITF Pharma for the US; Mundipharma for Europe, Russia, CIS, Asia, the Middle East, Africa and Latin America; and to Aspen Pharmacare for Australia and New Zealand. Starpharma also has licence agreements to market the VivaGel^® condom (an antiviral condom which includes VivaGel^® in the lubricant) in several regions, including Australia, Europe, Canada, China and Japan (Okamoto). The VivaGel^® condom has been launched in Australia and Canada under the Lifestyles^® Dual Protect™ brand.

DEP^® - Dendrimer Enhanced Product^®: Starpharma’s DEP^® drug delivery platform has demonstrated reproducible preclinical benefits across multiple internal and partnered DEP^® programs, including improved efficacy, safety and survival. Starpharma has two internal DEP^® products – DEP^® docetaxel and DEP^® cabazitaxel - in clinical development in patients with solid tumours, and further DEP^® products approaching clinical development. Starpharma’s partnered DEP^® programs include a multiproduct DEP^® licence with AstraZeneca, which involves the development and commercialisation of two novel oncology compounds, with potential to add more.

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