›› FDA meeting to discuss VivaGel® BV
approval in the US
In preparation for the upcoming meeting with the FDA, Starpharma
has completed and submitted a comprehensive package of
information, including further analyses of existing clinical data for
VivaGel® BV. A meeting with the FDA is expected to occur in the
second week of April 2019, subject to final confirmation of availability
of all parties. The meeting will be attended by senior representatives
of Starpharma as well as internationally recognised KOLs in the area
of BV, and the Company’s expert FDA regulatory consultants.
Since receiving the FDA’s request for confirmatory clinical data,
Starpharma has undertaken a comprehensive program with a view
to expediting approval, which has included extensive regulatory
advice from FDA experts and specialist US legal counsel. The
information submitted for the meeting, which includes additional
statistical analyses of existing data, was prepared in consultation
with, and following input from Starpharma’s team of expert FDA
consultants, including former senior FDA personnel, KOLs and
statisticians. These analyses provide further support for the approval
of VivaGel® BV.
The meeting is expected to clarify what confirmatory data will be
required for approval and whether the requirement can be satisfied
by additional analyses of existing clinical data, or whether this will
require the generation of new confirmatory clinical data. Starpharma
will be in a position to provide additional information following the
FDA meeting, once the outcomes of the discussion at the meeting
have been confirmed in writing.
Requests for additional data from the FDA are not unusual among
New Drug Applications. In 2016, almost 40% of NDAs submitted
were not approved in the first instance and additional data were
requested. A longer-term review between 2001 and 2015 showed
that 44% of NDAs were not approved upon first round review.
This document contains certain forward-looking statements, relating to Starpharma’s business, which can be identified by the use of forward-looking terminology such as “promising”, “plans”, “anticipated”, “will”, “project”, “believe”, “forecast”, “expected”, “estimated”, “targeting”,
“aiming”, “set to”, “potential”, “seeking to”, “goal”, “could provide”, “intends”, “is being developed”, “could be”, “on track”, or similar expressions, or by express or implied discussions regarding potential filings or marketing approvals, or potential future sales of product candidates. Such
forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no assurance that any
existing or future regulatory filings will satisfy the FDA’s and other health authorities’ requirements regarding any one or more product candidates nor can there be any assurance that such product candidates will be approved by any health authorities for sale in any market or that
they will reach any particular level of sales. In particular, management’s expectations regarding the approval and commercialization of the product candidates could be affected by, among other things, unexpected clinical trial results, including additional analysis of existing clinical
data, and new clinical data; unexpected regulatory actions or delays, or government regulation generally; our ability to obtain or maintain patent or other proprietary intellectual property protection; competition in general; government, industry, and general public pricing pressures; and
additional factors that involve significant risks and uncertainties about our products, product candidates, financial results and business prospects. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary
materially from those described herein as anticipated, believed, estimated or expected. Starpharma is providing this information as of the date of this presentation and does not assume any obligation to update any forward-looking statements contained in this document as a result of
new information, future events or developments or otherwise.
Feedback on VivaGel® BV from US clinicians and patients has been
extremely positive. We are looking forward to a productive and
informative meeting with the FDA. Starpharma is committed to
working with the FDA to secure approval with minimal delay to
make VivaGel® BV available to US patients as soon as possible.
Dr Jackie Fairley, CEO of Starpharma