Ann: US FDA requests further data for VivaGel BV approval, page-4

US FDA requests further data for VivaGel® BV approval FDA has advised Starpharma it requires confirmatory clinical data prior toapproval Starpharma plans to meet with the FDA as soon as possible to discuss theadditional data required for approval In parallel with FDA discussions, Starpharma and its non-US partners arecommitted to the active commercialisation of VivaGel® BV in non-US regions;VivaGel® BV is already approved in the EU and Australia, and has been licensed inmost regions around the world, with launches planned in 2019 Regulatory processes underway continue in other markets and are independent ofFDA approvalMelbourne, Australia; 27 December 2018: Starpharma (ASX: SPL, OTCQX: SPHRY)today received advice from the US FDA that it will require confirmatory clinical data prior toapproving VivaGel® BV for treatment of bacterial vaginosis (BV) and the prevention ofrecurrent BV (rBV).Starpharma is currently evaluating the details of FDA’s advice but anticipates being able toaddress the issues raised through the generation of confirmatory clinical efficacy data. Thecompany is requesting a meeting with the FDA as soon as practicable to discuss the datarequired and Starpharma is keen to secure approval with minimal delay. Encouragingly, theFDA did not identify any approvability issues in relation to the safety, manufacturing orquality of VivaGel® BV. Starpharma will also be discussing next steps with its US partner,ITF Pharma, and any potential impact on its US licence.VivaGel® BV is already approved in the EU and Australia, and regulatory processes currentlyunderway continue in other markets and are completely independent of FDA approval.Starpharma has licensed VivaGel® BV to Mundipharma for most non-US regions around theworld. Initial launches for VivaGel® BV will proceed as planned in multiple Mundipharmaregions (including Europe) and Australia during the first half of 2019.Dr Jackie Fairley, CEO of Starpharma, said: “Clearly we are surprised and extremelydisappointed with the FDA's requirement for confirmatory data in order to approve the NDAfor VivaGel® BV considering the comprehensive nature of the data provided. However, weare greatly encouraged by the FDA’s acknowledgement of the significant unmet medicalneed that would be fulfilled by the product, and they have expressed a desire to work withStarpharma to secure approval in order to make VivaGel® BV available to women in the USas soon as possible”.“Aside from VivaGel® BV, Starpharma will also continue to commercially exploit its deepportfolio of DEP® drugs, including DEP® docetaxel, DEP® cabazitaxel, DEP® irinotecan and arange of other internal and partnered programs, including the novel oncology agentAZD0466, which is being developed under licence by AstraZeneca”.“Importantly for the dendrimer component of VivaGel® BV, which is the first of its kind to bereviewed by the FDA under an NDA, no issues were raised in relation to the safety,manufacturing or quality of the product. We stand by the compelling data package submittedto the FDA, which has supported approvals in other major markets and is expected to enable 2multiple additional approvals throughout non-US regions. Starpharma is committed to theactive commercialisation of VivaGel® BV in these regions as well as commercialisation of ourDEP® portfolio, in parallel with addressing the requirements for approval in the US.”,concluded Dr Fairley.In their advice, the FDA acknowledged the demonstrated efficacy benefits of VivaGel® BValthough they have requested confirmatory data prior to approval. The FDA’sacknowledgment of the significant unmet medical need for an approved product to managerBV is consistent with the strong positive feedback from key opinion leaders, OBGYNs andpatients in the US. Starpharma knows that BV patients, US clinicians and BV key opinionleaders will be disappointed with the FDA’s decision on VivaGel® BV which will delay accessto the product in the US. Starpharma looks forward to working with the FDA to address theiradditional requirements as soon as practicable.