Apricus Biosciences Announces it is Seeking a Global Partner for Femprox, a Novel Treatment for Female Sexual Dysfunction
(Thomson Reuters ONE) -
SAN DIEGO, Calif., Aug. 19, 2015 (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc.
("Apricus" or the "Company") (Nasdaq:APRI) (http://www.apricusbio.com) announced
today that it re-affirms its intent to seek a global development partner for
Femprox(®), the Company's topical alprostadil cream for the treatment of female
sexual interest/arousal disorder ("FSIAD"). Femprox is a topically applied
formulation of 0.4% alprostadil delivered using Dodecyl 2-(N, N dimethylamino)-
propionate (DDAIP), Apricus' proprietary drug delivery technology. The Company
has completed a near 400 subject proof-of-concept clinical trial on Femprox,
which achieved statistical significance in both its primary and secondary
endpoints.
"Given the recent FDA approval of Sprout Pharmaceuticals, Inc.'s flibanserin for
female sexual dysfunction, Apricus now believes that a potential regulatory path
exists in the U.S. for Femprox," said Richard Pascoe, Apricus' Chief Executive
Officer. "We will immediately initiate a disciplined partnering process to
identify potential licensees for the global development and commercialization
rights for Femprox with the goal of maximizing our return on investment for the
potential benefit of shareholders."
About Femprox(®)
Femprox(®) is a 0.4% alprostadil cream intended for the treatment of FSIAD. To
date, Apricus Bio has completed nine clinical studies with Femprox, including
one, 98-subject Phase II study in the U.S. and a near 400-subject proof-of-
concept study in China. Femprox exerts a local, relaxant effect on vulvar and
clitoral blood vessels in women, leading to increased blood flow. The resultant
increase in lubrication and sensory feedback is believed to produce an increase
in sexual arousal in women with FSIAD.
About Apricus Biosciences, Inc.
Apricus Biosciences, Inc. (Nasdaq:APRI) is a biopharmaceutical company advancing
innovative medicines in urology and rheumatology. Apricus has initiated a Phase
2b trial for fispemifene, a selective estrogen receptor modulator for the
treatment of symptomatic male secondary hypogonadism, and plans to conduct
additional studies in other urological conditions. Apricus recently completed
enrollment in a Phase 2a trial for RayVa((TM)), its product candidate for the
treatment of the circulatory disorder Raynaud's phenomenon. Apricus' lead
commercial product, Vitaros(®), for the treatment of erectile dysfunction, is
approved in Europe and Canada and is being commercialized in several countries
in Europe. Apricus' marketing partners for Vitaros include Mylan NV, Takeda
Pharmaceuticals International GmbH, Hexal AG (Sandoz), Recordati Ireland Ltd.
(Recordati S.p.A.), Bracco S.p.A. and Laboratoires Majorelle. Apricus' second-
generation room temperature Vitaros is under development.
For further information on Apricus, visit http://www.apricusbio.com.
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 timing
and success of any development plan and the regulatory pathway for Femprox(®)
and Apricus' intent to partner with a third-party to develop Femprox. 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: Apricus' ability to partner with a third-party to develop Femprox on
favorable terms, or at all; potential changes in regulatory approval
requirements; dependence on any partner for key development activities, and the
potential that a partner will have limited resources or otherwise not prioritize
Femprox relative to its other development priorities; and the results of any
additional clinical trials on Femprox or other drug candidates targeting FSIAD.
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 GlobeNewswire on behalf of
GlobeNewswire clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Apricus Biosciences, Inc. via GlobeNewswire
[HUG#1946395]
Unternehmensinformation / Kurzprofil:
Datum: 19.08.2015 - 13:00 Uhr
Sprache: Deutsch
News-ID 414733
Anzahl Zeichen: 5682
contact information:
Town:
SAN DIEGO
Kategorie:
Business News
Diese Pressemitteilung wurde bisher 279 mal aufgerufen.
Die Pressemitteilung mit dem Titel:
"Apricus Biosciences Announces it is Seeking a Global Partner for Femprox, a Novel Treatment for Female Sexual Dysfunction"
steht unter der journalistisch-redaktionellen Verantwortung von
Apricus Biosciences, Inc. (Nachricht senden)
Beachten Sie bitte die weiteren Informationen zum Haftungsauschluß (gemäß TMG - TeleMedianGesetz) und dem Datenschutz (gemäß der DSGVO).
