Apricus Biosciences Announces Poster Presentation of Femprox(R) Phase III Clinical Data at American Urological Association Annual Meeting
Apricus Biosciences, Inc.
04.05.2012 16:05
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SAN DIEGO, 2012-05-04 16:05 CEST (GLOBE NEWSWIRE) --
Apricus Biosciences, Inc. ('Apricus Bio' or the 'Company') (Nasdaq:APRI)
(http://www.apricusbio.com) announced today a poster titled, 'Updated analyses
of randomized, double-blind, Phase 3 study of Femprox(r), an alprostadil cream
with a novel transdermal delivery technology for the treatment of female sexual
arousal disorder (FSAD),' will be presented as a moderated poster (#1498) at
the American Urological Association Annual Meeting which is being held May
19-23, 2012 in Atlanta, GA.
The poster presentation will discuss an updated analysis of the 400-women Phase
III clinical trial conducted by the Company to provide further evidence of the
statistically significant efficacy and safety profile of Apricus Bio's
investigational drug, Femprox(r) (topical alprostadil 0.4 % cream), for the
treatment of FSAD in pre- and post-menopausal women.
The data will be presented by Dr. Irwin Goldstein, Director of Sexual Medicine
at the Alvarado Hospital in San Diego, and a member of Apricus Bio's Femprox(r)
Clinical Advisory Board. Dr. Goldstein will present the data during the session
titled: 'Sexual Function/Dysfunction/Andrology: Medical and Non-Surgical
Therapy,' taking place Tuesday, May 22 from 8-10 a.m. local time. Dr. Goldstein
will give a short oral presentation which will be followed by a question and
answer period. Dr. Goldstein is the Editor of The Journal of Sexual Medicine, a
member of numerous sexual medicine societies, the author or co-author of
approximately 260 peer-reviewed papers, and an expert in the area of women's
sexual health.
About Femprox(r)
Femprox(r) is an alprostadil-based cream intended for the treatment of FSAD.
Apricus Bio has completed nine clinical studies to date, including one,
98-patient Phase II study in the U.S. and a 400-patient Phase III study in
China.
It is the Company's understanding that no product is currently approved for
FSAD in the U.S., a persistent or recurring inability to attain, or maintain
adequate sexual excitement, causing personal distress.
Femprox(r) 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 a clinically
significant increase in sexual arousal in women with FSAD.
About Apricus Biosciences, Inc.
Apricus Bio is a San Diego-based revenue-generating pharmaceutical company,
with commercial products and a broad pipeline across numerous therapeutic
classes.
Revenues and growth are driven from the sales of the Company's commercial
products through its Apricus Pharmaceuticals USA, Inc. and NexMed (USA), Inc.
subsidiaries and through out-licensing in certain territories of its product
pipeline and NexACT(r) technology.
Apricus Bio's current NexACT(r) pipeline includes Vitaros(r), approved in Canada
for the treatment of erectile dysfunction, as well as compounds in development
from pre-clinical through pre-registration currently focused on Sexual
Dysfunction, Oncology, Dermatology, Autoimmune, Pain, Anti-Infectives, Diabetes
and Consumer Healthcare.
Apricus Bio currently markets Totect(r) (dexrazoxane HCl), the only drug approved
in the US for the treatment of anthracycline extravasation. The Company also
plans to market in the U.S. or certain other countries the following products:
(a) Granisol(r) (granisetron HCI) oral solution, the only FDA-approved, oral,
ready-to-use liquid solution of granisetron, (b) Aquoral(tm), an FDA-cleared,
prescription-only spray for the treatment of Xerostomia (the medical term for
dry mouth due to a lack of saliva) and (c) NitroMist(r) (nitroglycerin sublingual
spray), an FDA-approved nitrate vasodilator indicated for acute relief of an
attack or acute prophylaxis of angina pectoris (chest pain) due to coronary
artery disease (narrowing of the blood vessels that supply blood to the heart).
The Company also expects to develop and/or acquire and then bring to market
additional pharmaceutical products in areas of care that will benefit patient
needs worldwide.
For further information on Apricus Bio, visit http://www.apricusbio.com, and
for information on its subsidiary please visit http://www.nexmedusa.com. You
can also receive information at http://twitter.com/apricusbio.
Apricus Bio's Forward-Looking Statement Safe Harbor
Statements under the Private Securities Litigation Reform Act, as amended: with
the exception of the historical information contained in this release, the
matters described herein contain forward-looking statements that involve risks
and uncertainties that may individually or mutually impact the matters herein
described for a variety of reasons that are outside the control of the Company,
including, but not limited to, its ability to further develop its products and
product candidates, to have its products and product candidates such as
Femprox(r) receive patent protection and be approved by relevant regulatory
authorities, to successfully commercialize such products as Totect(r) , Granisol(r)
, Aquoral(tm) and NitroMist(tm) and Vitaros(r) for erectile dysfunction and NexACT(r)
product candidates and drug delivery technology and to achieve its development,
commercialization and financial goals. Readers are cautioned not to place undue
reliance on these forward-looking statements as actual results could differ
materially from the forward-looking statements contained herein. Readers are
urged to read the risk factors set forth in the Company's 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 or without charge from the Company.
CONTACT: Apricus Bio Investor Relations:
David Pitts
Argot Partners
212-600-1902
david@argotpartners.com
News Source: NASDAQ OMX
04.05.2012 Dissemination of a Corporate News, transmitted by DGAP -
a company of EquityStory AG.
The issuer is solely responsible for the content of this announcement.
DGAP's Distribution Services include Regulatory Announcements,
Financial/Corporate News and Press Releases.
Media archive at www.dgap-medientreff.de and www.dgap.de
---------------------------------------------------------------------------
Language: English
Company: Apricus Biosciences, Inc.
United States
Phone:
Fax:
E-mail:
Internet:
ISIN: US9901429525
WKN:
End of Announcement DGAP News-Service
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Apricus Biosciences, Inc.
04.05.2012 16:05
---------------------------------------------------------------------------
SAN DIEGO, 2012-05-04 16:05 CEST (GLOBE NEWSWIRE) --
Apricus Biosciences, Inc. ('Apricus Bio' or the 'Company') (Nasdaq:APRI)
(http://www.apricusbio.com) announced today a poster titled, 'Updated analyses
of randomized, double-blind, Phase 3 study of Femprox(r), an alprostadil cream
with a novel transdermal delivery technology for the treatment of female sexual
arousal disorder (FSAD),' will be presented as a moderated poster (#1498) at
the American Urological Association Annual Meeting which is being held May
19-23, 2012 in Atlanta, GA.
The poster presentation will discuss an updated analysis of the 400-women Phase
III clinical trial conducted by the Company to provide further evidence of the
statistically significant efficacy and safety profile of Apricus Bio's
investigational drug, Femprox(r) (topical alprostadil 0.4 % cream), for the
treatment of FSAD in pre- and post-menopausal women.
The data will be presented by Dr. Irwin Goldstein, Director of Sexual Medicine
at the Alvarado Hospital in San Diego, and a member of Apricus Bio's Femprox(r)
Clinical Advisory Board. Dr. Goldstein will present the data during the session
titled: 'Sexual Function/Dysfunction/Andrology: Medical and Non-Surgical
Therapy,' taking place Tuesday, May 22 from 8-10 a.m. local time. Dr. Goldstein
will give a short oral presentation which will be followed by a question and
answer period. Dr. Goldstein is the Editor of The Journal of Sexual Medicine, a
member of numerous sexual medicine societies, the author or co-author of
approximately 260 peer-reviewed papers, and an expert in the area of women's
sexual health.
About Femprox(r)
Femprox(r) is an alprostadil-based cream intended for the treatment of FSAD.
Apricus Bio has completed nine clinical studies to date, including one,
98-patient Phase II study in the U.S. and a 400-patient Phase III study in
China.
It is the Company's understanding that no product is currently approved for
FSAD in the U.S., a persistent or recurring inability to attain, or maintain
adequate sexual excitement, causing personal distress.
Femprox(r) 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 a clinically
significant increase in sexual arousal in women with FSAD.
About Apricus Biosciences, Inc.
Apricus Bio is a San Diego-based revenue-generating pharmaceutical company,
with commercial products and a broad pipeline across numerous therapeutic
classes.
Revenues and growth are driven from the sales of the Company's commercial
products through its Apricus Pharmaceuticals USA, Inc. and NexMed (USA), Inc.
subsidiaries and through out-licensing in certain territories of its product
pipeline and NexACT(r) technology.
Apricus Bio's current NexACT(r) pipeline includes Vitaros(r), approved in Canada
for the treatment of erectile dysfunction, as well as compounds in development
from pre-clinical through pre-registration currently focused on Sexual
Dysfunction, Oncology, Dermatology, Autoimmune, Pain, Anti-Infectives, Diabetes
and Consumer Healthcare.
Apricus Bio currently markets Totect(r) (dexrazoxane HCl), the only drug approved
in the US for the treatment of anthracycline extravasation. The Company also
plans to market in the U.S. or certain other countries the following products:
(a) Granisol(r) (granisetron HCI) oral solution, the only FDA-approved, oral,
ready-to-use liquid solution of granisetron, (b) Aquoral(tm), an FDA-cleared,
prescription-only spray for the treatment of Xerostomia (the medical term for
dry mouth due to a lack of saliva) and (c) NitroMist(r) (nitroglycerin sublingual
spray), an FDA-approved nitrate vasodilator indicated for acute relief of an
attack or acute prophylaxis of angina pectoris (chest pain) due to coronary
artery disease (narrowing of the blood vessels that supply blood to the heart).
The Company also expects to develop and/or acquire and then bring to market
additional pharmaceutical products in areas of care that will benefit patient
needs worldwide.
For further information on Apricus Bio, visit http://www.apricusbio.com, and
for information on its subsidiary please visit http://www.nexmedusa.com. You
can also receive information at http://twitter.com/apricusbio.
Apricus Bio's Forward-Looking Statement Safe Harbor
Statements under the Private Securities Litigation Reform Act, as amended: with
the exception of the historical information contained in this release, the
matters described herein contain forward-looking statements that involve risks
and uncertainties that may individually or mutually impact the matters herein
described for a variety of reasons that are outside the control of the Company,
including, but not limited to, its ability to further develop its products and
product candidates, to have its products and product candidates such as
Femprox(r) receive patent protection and be approved by relevant regulatory
authorities, to successfully commercialize such products as Totect(r) , Granisol(r)
, Aquoral(tm) and NitroMist(tm) and Vitaros(r) for erectile dysfunction and NexACT(r)
product candidates and drug delivery technology and to achieve its development,
commercialization and financial goals. Readers are cautioned not to place undue
reliance on these forward-looking statements as actual results could differ
materially from the forward-looking statements contained herein. Readers are
urged to read the risk factors set forth in the Company's 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 or without charge from the Company.
CONTACT: Apricus Bio Investor Relations:
David Pitts
Argot Partners
212-600-1902
david@argotpartners.com
News Source: NASDAQ OMX
04.05.2012 Dissemination of a Corporate News, transmitted by DGAP -
a company of EquityStory AG.
The issuer is solely responsible for the content of this announcement.
DGAP's Distribution Services include Regulatory Announcements,
Financial/Corporate News and Press Releases.
Media archive at www.dgap-medientreff.de and www.dgap.de
---------------------------------------------------------------------------
Language: English
Company: Apricus Biosciences, Inc.
United States
Phone:
Fax:
E-mail:
Internet:
ISIN: US9901429525
WKN:
End of Announcement DGAP News-Service
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