Apricus Biosciences, Inc.
21.05.2012 15:35
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SAN DIEGO, 2012-05-21 15:35 CEST (GLOBE NEWSWIRE) --
Apricus Biosciences, Inc. ('Apricus Bio' or the 'Company') (Nasdaq:APRI)
(http://www.apricusbio.com) announced today that the United States ('U.S.')
Food and Drug Administration ('FDA') has granted the Company's request for a
Type C meeting to obtain regulatory guidance from the agency for Femprox(r), the
Company's topical alprostadil cream for the treatment for female sexual arousal
disorder (FSAD). The meeting is expected to take place in late July 2012 and
the purpose of the meeting is to obtain feedback from the agency regarding the
suitability of Femprox(r)'s clinical, preclinical, and quality control data to
support a New Drug Approval ('NDA') in the U.S.
Apricus Bio expects to meet with the Reproductive and Urologic Products
Division of the Office of New Drugs within the Center for Drug Evaluation &
Research (CDER) within FDA. The Study Endpoints and Labeling Division within
CDER also will be consulted as part of the meeting. Femprox(r) is a topically
applied formulation of 0.4% alprostadil delivered using Dodecyl 2-(N, N
dimethylamino)-propionate (DDAIP), Apricus Bio's proprietary drug delivery
technology. The Company believes that Femprox(r) is further along in development
than any other product for FSAD and is the only product candidate to have
successfully completed a near 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 the Reproductive and Urologic Products
Division of the FDA, and gaining clarity regarding the development path forward
for Femprox(r) in the U.S.,' 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 the high response rate and
safety profile seen in the clinical trials. Upon completion of this meeting we
believe we will be one step closer to filing for this product in the U.S. and
bringing a new treatment option to women suffering from FSAD.'
Apricus Bio was recently granted a Pre-New Drug Submission (Pre-NDS) meeting
for Femprox(r) with Health Canada which is expected to take place on July 17,
2012, and the Company is also working with its European agents to conduct
similar meetings with various European health agencies.
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-subject Phase II study in the U.S. and a near 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(tm) (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.
Apricus Bio Investor Relations:
David Pitts
Argot Partners
212-600-1902
david@argotpartners.com
News Source: NASDAQ OMX
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Language: English
Company: Apricus Biosciences, Inc.
United States
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ISIN: US9901429525
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DGAP-News: Apricus Biosciences Granted Regulatory Meeting With FDA for Femprox(R) for the Treatment of Female Sexual Arousal Disorder
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