• Two pivotal VivaGel^® BV phase 3 trials for the prevention of recurrent bacterial vaginosis now complete
• Topline results expected Q2 CY2017
• Final data collation, blinded QC reviews, and bio-statistical programming underway
• Special Protocol Agreement (SPA) in place with FDA for study design
• QIDP designation and Fast Track status granted to accelerate FDA review and approval
• US Marketing application for BV Treatment in preparation with submission expected in the near future with Prevention of BV to follow
• Global licensing activities for VivaGel^® BV underway

Melbourne, Australia; 30 March 2017: Starpharma Holdings Ltd (ASX: SPL, OTCQX: SPHRY) today announced completion of its international, multicentre, phase 3 clinical studies evaluating VivaGel^® BV for the prevention of recurrent bacterial vaginosis (rBV). Starpharma expects topline results of the trials to be available in the second quarter of 2017.

The two pivotal phase 3, double-blind, randomised, placebo-controlled trials compare the rate of BV recurrence in women using VivaGel^® BV to the rate of recurrence in women using a placebo gel during a 16 week treatment period with the primary endpoint measured as patients complete the treatment period. The trials were conducted at sites across the US, Europe, Canada, Mexico and Asia. Topline results of the trials will be available late in Q2 CY17 following data collation, routine blinded QC and bio-statistical programming of the extensive data set.

Starpharma has been granted a Special Protocol Agreement (SPA) by the FDA which provides the company with binding FDA agreement on the trial design including the primary endpoint. The achievement of an SPA significantly reduces the US regulatory risk associated with clinical development, by specifying upfront the FDA’s agreement with the trial design and providing certainty in the trial data required to support marketing approval.

Starpharma Chief Executive Officer, Dr Jackie Fairley, said: “The completion of these pivotal phase 3 trials is a significant milestone for Starpharma. The market for prevention of BV recurrence is estimated to be worth more than US$1 billion and there are currently no approved products. As we look forward to the release of results in the next quarter, we are in parallel preparing our US FDA marketing applications, and are engaged in active negotiations for commercial rights to VivaGel^® BV. The granting of QIDP designation and Fast Track status by the FDA for both treatment of BV and prevention of rBV in January are also important developments, attracting significant commercial interest.”

Bacterial vaginosis affects around 30% of women in the US with around 50-60% suffering from the recurrent form. VivaGel^® BV will address a significant unmet medical need for rBV in a market with a value estimated to be in excess of US$1 billion and where there are currently no approved products. 

VivaGel^® BV is already approved in Europe for the treatment and relief of BV symptoms and regulatory reviews including by the TGA are well advanced. VivaGel^® BV has been licensed in Australia and New Zealand to Aspen Pharmacare and extensive licensing discussions are also underway globally.

Next steps

• Trial Results: The extensive data set from the trials will now undergo data collation, routine blinded QC review, and bio-statistical programming, which, based on the size and duration of the trial, is expected to take around 10-12 weeks. Until this time, data will remain blinded.  Results are expected to be announced late in the second quarter of CY2017.

• US Marketing Application: Starpharma is already well advanced in the compilation of a VivaGel^® BV marketing application (New Drug Application) for submission to the FDA. It is expected that an application will be made in the near future for the treatment of BV, with the rBV indication to follow.  The VivaGel^® BV marketing applications will benefit from QIDP designation and Fast Track status granted by the FDA earlier this year, each carrying significant benefits for regulatory approval and commercialisation for both indications. Benefits include priority regulatory review and an additional five years’ of market exclusivity. The Fast Track designation enables more frequent interactions with the FDA and expedited review, leading to faster approval, and facilitates earlier market access for patients.

• Partnering: Starpharma has licensed VivaGel^® BV to Aspen Pharmacare for Australia and New Zealand and also has advanced negotiations underway with a number of parties for other regions, including Europe. Global negotiations have been positively impacted by the recent developments in the US including revision to the FDA draft guidance for BV treatment, Fast Track status and the grant of QIDP designation for both indications.

About VivaGel^® BV

VivaGel^® BV is a water based gel for topical treatment and rapid relief of bacterial vaginosis (BV). It is based on Starpharma’s SPL7013, astodrimer sodium, a proprietary dendrimer that blocks certain bacteria involved in BV and also has potent antiviral activity against certain viruses (HIV, HSV, HPV, Zika).

The VivaGel^® BV treatment product, which is already approved in Europe, targets an area of significant unmet medical need in a high-value market (est. US$750M) and has been licensed to Aspen Pharmacare with preparations underway for launch. A second VivaGel^® BV product is in phase 3 clinical development for the prevention of recurrent BV which is another high value market (est. US$1B) for which there are currently no clinically approved products.

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 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.

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