Bli medlem
Bli medlem

Du är här


Apricus Biosciences, Inc.: Apricus Biosciences Provides Update on Vitaros NDA Following Receipt of FDA Feedback

Apricus Re-Affirms Plans to Re-Submit Vitaros U.S. NDA

SAN DIEGO, Nov. 18, 2016 (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc.
(Nasdaq:APRI), a biopharmaceutical company advancing innovative medicines in
urology and rheumatology, today announced that it has received feedback in
response to its previously announced Type B Meeting request to the U.S. Food
and Drug Administration (FDA). The purpose of the FDA meeting request was to
confirm Apricus' strategy for addressing the deficiencies contained in the
2008 Complete Response letter. Based upon our expert panel's review of the
FDA's feedback, and the available Vitaros clinical and non-clinical data used
to obtain regulatory approvals outside of the U.S., the Company believes that
there is a viable regulatory pathway for resubmission of the Vitaros NDA in
the U.S. and, as such, we intend to re-submit the NDA as soon as possible in

Specifically, the FDA provided clarity on the requirements needed to address
the deficiencies in the 2008 Complete Response letter to include suggested
additional analysis of existing clinical and non-clinical data. The FDA
feedback did not indicate that new clinical studies would be required for
re-submission. Importantly, the FDA determined that Vitaros, under current
regulations, is now considered a drug-device combination and, as such,
Apricus was advised to meet with the Office of Product Quality to confirm the
necessary device engineering and compliance requirements for the NDA

"We are encouraged by the FDA's constructive feedback regarding the Vitaros
NDA re-submission strategy and we appreciate their valuable input, which we
believe will help to further strengthen our re-submission," said Richard
Pascoe, Chief Executive Officer of Apricus. "Importantly, we believe that we
can adequately address the DDAIP safety and partner transference risk noted
in the 2008 Complete Response letter and we can further strengthen our
clinical benefit section in the planned re-submission, using a methodology
provided to us by the FDA. However, given the determination by the FDA that
Vitaros is now a drug-device combination, we will need to meet with the
Office of Product Quality to clarify any additional conditions that may be
required for approvability, which will likely delay our re-submission until
the second half of 2017."

About Apricus Biosciences, Inc.

Apricus Biosciences, Inc. (APRI) is a biopharmaceutical company advancing
innovative medicines in urology and rheumatology. Apricus' commercial
product, Vitaros®, for the treatment of erectile dysfunction, is approved in
Canada and certain countries in Europe, Latin America and the Middle East and
is being commercialized in several countries in Europe. In September 2015,
Apricus in-licensed the U.S. development and commercialization rights for
Vitaros from Allergan. Apricus' marketing partners for Vitaros include
Recordati Ireland Ltd. (Recordati), Ferring International Center S.A.
(Ferring Pharmaceuticals), Laboratoires Majorelle, Bracco S.p.A., Mylan NV
and Elis Pharmaceuticals Ltd. Apricus currently has one active product
candidate, RayVa(TM), its product candidate for the treatment of the
circulatory disorder Raynaud's phenomenon.

For further information on Apricus, visit

*Vitaros® is a registered trademark of NexMed International Limited. Such
trademark is registered in certain countries throughout the world and pending
registration in the United States.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of
the Private Securities Litigation Reform Act, as amended. Statements in this
press release that are not purely historical are forward-looking statements.
Such forward-looking statements include, among other things: references to
the need for additional clinical or pre-clinical data prior to the
re-submission of the Vitaros NDA and the FDA's view on such a need; the
timing of the re-submission of the Vitaros NDA, including the need to address
the issues raised by the FDA's feedback or any issues raised by the Office of
Product Quality related to the FDA's determination that Vitaros is now a
drug-device combination; and Apricus' ability to address the clinical and
non-clinical data deficiencies and other deficiencies noted in the 2008
Complete Response letter. Actual results could differ from those projected in
any forward-looking statements due to a variety of reasons that are outside
of Apricus' control, including, but not limited to: the FDA, including the
Office of Product Quality, requiring additional clinical and pre-clinical
data prior to the Vitaros NDA re-submission; Apricus' ability to address any
conditions for approvability raised by the FDA's Office of Product Quality;
the risks of any additional adverse safety or other data arising from the
sales and use of Vitaros in certain countries in Europe and elsewhere;
Apricus' financial position and need for additional capital to fund its
operations through the NDA re-submission and the FDA's review of the NDA,
which may be adversely impacted if Apricus is unable to maintain the
continued listing of its common stock on the Nasdaq stock market; and other
risks identified by Apricus in its reports filed with the Securities and
Exchange Commission (SEC). These forward-looking statements are made as of
the date of this press release, and Apricus assumes no obligation to update
the forward-looking statements, or to update the reasons why actual results
could differ from those projected in the forward-looking statements. Readers
are urged to read the risk factors set forth in Apricus' most recent annual
report on Form 10-K, subsequent quarterly reports filed on Form 10-Q, and
other filings made with the SEC. Copies of these reports are available from
the SEC's website at or without charge from Apricus.

Matthew Beck
The Trout Group LLC
(646) 378-2933

This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Apricus Biosciences, Inc. via Globenewswire

Författare Hugin

Tala om vad ni tycker

Tala om vad ni tycker

Ni är just nu inne på en betaversion av nya aktiespararna. Lämna gärna feedback på vad ni tycker i formuläret nedan.