Starpharma Holdings Ltd. (SPHRY: OTCQX International) | VivaGel® BV granted QIDP and Fast Track designation by US FDA


VivaGel® BV granted QIDP and Fast Track designation by US FDA

Jan 11, 2017

OTC Disclosure News Service

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®

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

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.

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.

About Starpharma

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.

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