MELBOURNE, Australia--(EON: Enhanced Online News)--Starpharma Holdings Ltd (ASX:SPL, OTCQX:SPHRY) today announced it has been granted Qualified Infectious Disease Product (QIDP) and Fast Track designation for VivaGel® BV by the US Food and Drug Administration (FDA).
QIDP and Fast Track designations were granted independently for both the VivaGel® BV treatment and prevention indications for bacterial vaginosis (BV). This positive development recognises the high unmet medical need in the management of BV and the potential of VivaGel® BV to address that need for both treatment and prevention of recurrent BV, markets estimated to be worth in excess of US$1 billion globally.
These two important designations are designed to make new therapeutics available to patients as rapidly as possible, carrying significant benefits for regulatory approval and commercialisation of VivaGel® BV.
QIDP designation was created by the Generating Antibiotic Incentives Now (GAIN) Act, and provides incentives for the development of new antimicrobial products. These incentives 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.
Starpharma CEO, Dr Jackie Fairley, said, “We are delighted that the FDA has granted VivaGel® QIDP and Fast Track designation. This is a very positive commercial development which expedites the path to US market entry for VivaGel® BV. VivaGel® BV is understood to be the only product to receive such designations for both the BV treatment and prevention indications. The granting of QIDP and Fast Track status is important to accelerate access to VivaGel® BV for patients in the US that suffer from BV.”
Current status of VivaGel® BV programs
VivaGel® BV – to prevent recurrent BV (chronic use)
VivaGel® BV for the prevention of recurrent BV is currently being evaluated via two phase 3 clinical studies. Patient enrolment in the program was completed in October 2016, and the trials are expected to conclude in Q1 of CY2017, with top line results expected in Q2.
VivaGel® BV – BV treatment and symptomatic relief (acute use)
VivaGel® BV for treatment of BV, which has already been evaluated in phase 3 clinical trials, has been approved for marketing in the EU and is under review in a number of other jurisdictions.
In July 2016, the FDA published a revised draft regulatory guidance for the development of products for BV treatment. The FDA guidance now recommends that the assessment of the primary endpoint for efficacy in BV treatment studies occur 7-14 days after commencing treatment (rather than 21-30 days after commencing treatment). This timing aligns favourably with Starpharma’s phase 3 clinical trial results, which showed a highly statistically significant benefit of VivaGel® BV at this time point. This revised guidance, coupled with the designations above, significantly enhances the commercial opportunity for VivaGel® BV.
Starpharma is already preparing and plans to submit a marketing application for VivaGel® BV to the FDA in the near future. As noted above, a key benefit of the QIDP and Fast Track status is the priority and expedited review aimed at giving potential patients earlier access to approved products.
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.