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21/05/2012 15:35:00

Apricus Biosciences Granted Regulatory Meeting With FDA for Femprox(R) for the Treatment of Female Sexual Arousal Disorder

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®, 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®'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® 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® 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® in the U.S.," said Bassam Damaj, PhD, President and Chief

Executive Officer of Apricus Bio. "We believe Femprox® 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® 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®

Femprox® is a 0.4% alprostadil cream intended for the treatment of FSAD. 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 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® 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® 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® technology.

Apricus Bio's current NexACT® pipeline includes Vitaros®, 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® (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® (granisetron HCI) oral solution, the only FDA-approved, oral,

ready-to-use liquid solution of granisetron, (b) Aquoral™, 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™ (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® receive patent protection and be approved by relevant regulatory

authorities, to successfully commercialize such products as Totect® , Granisol®

, Aquoral™ and NitroMist™ and Vitaros® for erectile dysfunction and NexACT®

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

21 mai: CIMENTS FRANCAIS : Déclaration des transactions sur actions propr..
21 mai: Crédit Agricole Ille-et-Vilaine : Descriptif du programme de rach..

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