Starpharma (ASX:SPL) has announced revised timing for results of its two pivotal VivaGel BV phase 3 trials for the prevention of recurrent bacterial vaginosis (BV) and said it is "actively engaged" in negotiations for commercial rights to the product.
According to the company, the results are now expected to be available in late July or early August this year, with the timing allowing for additional confirmation from the FDA on the statistical analysis plan.
The plan is designed to ensure consistency of the trial data analyses with Starpharma’s Special Protocol Agreement (SPA) prior to its un-blinding and analysis. 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," said the company in a statement.
"Starpharma is also leveraging the FDA’s recently granted QIDP designation and Fast Track status for these trial results," it said. "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."
The company said it is also well-advanced in 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, it said.
Starpharma said it is "actively engaged" in both global and regional negotiations for commercial rights to VivaGel BV. A number of term sheets under discussion, it said.
"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," it added.