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Apricus Biosciences Announces FDA Acknowledgement of Vitaros(TM) Class 2 NDA Resubmission

ID: 1519391
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(Thomson Reuters ONE) -


PDUFA Goal Date of February 17, 2018

SAN DIEGO, Aug. 31, 2017 (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc.
(Nasdaq:APRI), a biopharmaceutical company advancing innovative medicines in
urology and rheumatology, today announced that the U.S. Food and Drug
Administration ("FDA") has acknowledged receipt of its recently resubmitted New
Drug Application ("NDA") for Vitaros(TM) (alprostadil, DDAIP.HCl) and considers
it a complete, class 2 response to Apricus'' 2008 action letter.  The PDUFA
(Prescription Drug User Fee Act) goal date for completion of the FDA''s review of
the Vitaros NDA is set for February 17, 2018, which is the standard six month
review period for NDA resubmissions.

Vitaros is a novel, on-demand topical cream for the treatment of erectile
dysfunction ("ED") and a new potential entrant into the U.S. ED treatment
market. Vitaros has been approved in Canada, Mexico, and certain countries in
Europe, Latin America and the Middle East, and the product is being
commercialized by Ferring International Center S.A. and its licensees throughout
Europe and in the Middle East.

"We are very pleased to announce that the FDA has acknowledged receipt of our
U.S. Vitaros NDA resubmission and our PDUFA goal date is February 17, 2018,"
stated Richard W. Pascoe, Chief Executive Officer. "The FDA has determined that
the resubmission is a complete, class 2 response to our 2008 action letter.
Importantly, we believe that Vitaros, if approved, will address a significant
unmet need in the erectile dysfunction market."

Apricus in-licensed the U.S. development and commercialization rights for
Vitaros from Allergan pursuant to a license agreement entered into between the
parties in September 2015.  The U.S. Vitaros asset was previously purchased by


Warner Chilcott, now a subsidiary of Allergan, from Apricus back in February
2009.  Pursuant to the terms of the license agreement, upon FDA approval of the
NDA for Vitaros, Allergan may elect to exercise a one-time opt-in right to
assume all future marketing and selling activities in the United States. If
Allergan exercises its opt-in right, Apricus may receive up to a total of $25
million in upfront and potential launch milestone payments, plus a double-digit
royalty on net sales of Vitaros. If Allergan elects not to exercise its opt-in
right, Apricus may commercialize Vitaros and in return will pay Allergan a
double-digit royalty on net sales of Vitaros.

About Apricus Biosciences, Inc.

Apricus Biosciences, Inc. (APRI) is a biopharmaceutical company advancing
innovative medicines in urology and rheumatology. Apricus has two product
candidates currently in development. Vitaros is a product candidate in the
United States for the treatment of erectile dysfunction, which is in-licensed
from Warner Chilcott Company, Inc., now a subsidiary of Allergan plc (Allergan).
RayVa is our product candidate in Phase 2 development for the treatment of the
circulatory disorder Raynaud''s phenomenon, secondary to scleroderma, for which
we own worldwide rights.

For further information on Apricus, visit http://www.apricusbio.com.

Vitaros(TM) is Apricus'' trademark in the United States, which is pending
registration and subject to the agreement with Allergan.  Vitaros® is a
registered trademark of Ferring International Center S.A. in certain countries
outside of the United States.  RayVa(TM) is Apricus'' trademark, which 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: the timing of the FDA''s
review of the re-submission of the Vitaros NDA; the potential approval of the
NDA by the FDA; and Vitaros addressing a significant unmet need in the ED
market. 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 could require additional clinical and
pre-clinical data; Apricus'' ability to have addressed any conditions for
approvability raised by the FDA in the 2008 action letter or the FDA identifying
other deficiencies in the resubmission; risks related to the possibility of an
advisory committee meeting related to Vitaros; 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 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; competition in
the ED 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 www.sec.gov or without charge from Apricus.

CONTACT:
Matthew Beck
mbeck(at)troutgroup.com
The Trout Group
(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






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Date: 08/31/2017 - 13:00
Language: English
News-ID 1519391
Character count: 2232
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Firma: Apricus Biosciences, Inc.
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