Health Canada Grants Apricus Biosciences Pre-NDS Meeting for Femprox for Female Sexual Arousal Disorder
Apricus Biosciences, Inc.
07.05.2012 16:10
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SAN DIEGO, 2012-05-07 16:10 CEST (GLOBE NEWSWIRE) --
Apricus Biosciences, Inc. ('Apricus Bio' or the 'Company') (Nasdaq:APRI)
(http://www.apricusbio.com) announced today that Health Canada has granted the
Company's request for a Pre-New Drug Submission ('Pre-NDS') meeting to obtain
regulatory guidance from the agency for Femprox(r), its topical alprostadil cream
for the treatment of female sexual arousal disorder ('FSAD'). The meeting is
scheduled to take place on July 17, 2012. Apricus Bio expects to obtain
feedback from Health Canada regarding the suitability of their existing
clinical, preclinical, and chemistry data to support a New Drug Submission
('NDS') in Canada.
Femprox(r) is a topically applied formulation of 0.4% alprostadil delivered using
dodecyl 2-(N, N dimethylamino)-propionate hydrochloride (DDAIP HCl) or NexACT(r),
Apricus Bio's proprietary drug delivery technology. To the Company's current
belief, Femprox(r) is further along in development than any other product for
FSAD and is the only product candidate to have successfully completed an
approximately 400 subject Phase III clinical trial, a trial which achieved
statistical significance in both its primary and secondary endpoints.
'We look forward to working with Health Canada and gaining clarity regarding
the development path forward for Femprox(r) in Canada,' said Bassam Damaj, PhD,
President and Chief Executive Officer of Apricus Bio. 'We believe Femprox(r) is a
unique treatment option for FSAD, not only because of its topical delivery,
local mechanism of action, and its safety profile, but also because of its high
response rate. Upon completion of this meeting we will be one step closer to
filing in the Canadian market and bringing a new treatment option to women
suffering from FSAD.'
About Femprox(r)
Femprox(r) is a 0.4% alprostadil cream intended for the treatment of FSAD. To
date, Apricus Bio has completed nine clinical studies with Femprox(r), including
one, 98-patient Phase II study in the U.S. and an approximately 400 subject
Phase III study in China. To the Company's knowledge, no product is currently
approved to treat FSAD, a persistent or recurring inability to attain, or
maintain adequate sexual excitement, causing personal distress. Estimates of
the FSAD market size put it on par with erectile dysfunction in males, and
possibly larger.
Femprox(r) exerts a relaxant effect on vulvar and clitoral blood vessels in
women, leading to increased blood flow. This leads to pelvic engorgement and
enhanced secretion activity of the vulvar epithelium. The resultant increase in
lubrication and sensory feedback due to pelvic engorgement is believed to
produce a clinically significant increase in sexual arousal in women with FSAD.
Femprox(r) enables a rapid permeation of blood deep into the target tissues thus
enabling a new pharmacotherapy for the treatment of FSAD through increasing the
blood flow to tissue.
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), Vitaros(r) and Femprox(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
07.05.2012 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.
07.05.2012 16:10
---------------------------------------------------------------------------
SAN DIEGO, 2012-05-07 16:10 CEST (GLOBE NEWSWIRE) --
Apricus Biosciences, Inc. ('Apricus Bio' or the 'Company') (Nasdaq:APRI)
(http://www.apricusbio.com) announced today that Health Canada has granted the
Company's request for a Pre-New Drug Submission ('Pre-NDS') meeting to obtain
regulatory guidance from the agency for Femprox(r), its topical alprostadil cream
for the treatment of female sexual arousal disorder ('FSAD'). The meeting is
scheduled to take place on July 17, 2012. Apricus Bio expects to obtain
feedback from Health Canada regarding the suitability of their existing
clinical, preclinical, and chemistry data to support a New Drug Submission
('NDS') in Canada.
Femprox(r) is a topically applied formulation of 0.4% alprostadil delivered using
dodecyl 2-(N, N dimethylamino)-propionate hydrochloride (DDAIP HCl) or NexACT(r),
Apricus Bio's proprietary drug delivery technology. To the Company's current
belief, Femprox(r) is further along in development than any other product for
FSAD and is the only product candidate to have successfully completed an
approximately 400 subject Phase III clinical trial, a trial which achieved
statistical significance in both its primary and secondary endpoints.
'We look forward to working with Health Canada and gaining clarity regarding
the development path forward for Femprox(r) in Canada,' said Bassam Damaj, PhD,
President and Chief Executive Officer of Apricus Bio. 'We believe Femprox(r) is a
unique treatment option for FSAD, not only because of its topical delivery,
local mechanism of action, and its safety profile, but also because of its high
response rate. Upon completion of this meeting we will be one step closer to
filing in the Canadian market and bringing a new treatment option to women
suffering from FSAD.'
About Femprox(r)
Femprox(r) is a 0.4% alprostadil cream intended for the treatment of FSAD. To
date, Apricus Bio has completed nine clinical studies with Femprox(r), including
one, 98-patient Phase II study in the U.S. and an approximately 400 subject
Phase III study in China. To the Company's knowledge, no product is currently
approved to treat FSAD, a persistent or recurring inability to attain, or
maintain adequate sexual excitement, causing personal distress. Estimates of
the FSAD market size put it on par with erectile dysfunction in males, and
possibly larger.
Femprox(r) exerts a relaxant effect on vulvar and clitoral blood vessels in
women, leading to increased blood flow. This leads to pelvic engorgement and
enhanced secretion activity of the vulvar epithelium. The resultant increase in
lubrication and sensory feedback due to pelvic engorgement is believed to
produce a clinically significant increase in sexual arousal in women with FSAD.
Femprox(r) enables a rapid permeation of blood deep into the target tissues thus
enabling a new pharmacotherapy for the treatment of FSAD through increasing the
blood flow to tissue.
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), Vitaros(r) and Femprox(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
07.05.2012 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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