VivaGel® BV phase 3 results timing and commercialisation

4 July 2017

Melbourne, Australia; Starpharma (ASX: SPL, OTCQX: SPHRY) today announced revised timing for results of its two pivotal VivaGel® BV phase 3 trials for the prevention of recurrent bacterial vaginosis – now expected to be available in late July/early August 2017.

This timing has allowed for additional confirmation from the US FDA on the statistical analysis plan to ensure consistency of the trial data analyses with Starpharma’s Special Protocol Agreement (SPA), prior to un-blinding and analysis of the data. The SPA granted by the FDA provides binding FDA agreement on the phase 3 trial design including the primary endpoint.

Following completion of the trials, data collation and routine blinded quality control review were undertaken and are now complete. The statistical analysis plan and bio-statistical programming are now being finalised, prior to the unblinding of the data.

Starpharma is also leveraging the FDA’s recently granted QIDP designation and Fast Track status for these trial results. These designations carry significant benefits for regulatory approval and commercialisation, including increased dialogue with the FDA, priority regulatory review and an additional five years of market exclusivity.

In parallel, Starpharma is well-advanced in its preparation of the New Drug Application (NDA) submission for VivaGel® for the treatment and symptomatic relief of BV. This NDA is planned for as early as possible in the second half of 2017, with final pre-submission discussions with the FDA to be held in July 2017.

Appointment of global healthcare investment bank

Starpharma is also actively engaged in both global and regional negotiations for commercial rights to VivaGel® BV, with a number of term sheets under discussion. Negotiations have been positively impacted by the FDA recently granting Starpharma QIDP and Fast Track designations for both indications which has attracted further significant commercial interest in VivaGel® BV. As part of this process, the Company has appointed a leading global healthcare investment bank to support the competitive process for negotiating commercial terms with potential partners for VivaGel® BV. 

Download ASX Announcement: VivaGel® BV phase 3 results timing and commercialisation (pdf file, 173kb)

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