Apricus Biosciences Provides First Quarter 2013 Corporate Update

Apricus Biosciences Provides First Quarter 2013 Corporate Update

Company to Host Conference Call/Webcast Today at 9:00 AM ET

SAN DIEGO, May 10, 2013 (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc.
("Apricus Bio" or the "Company") (Nasdaq:APRI) (http://www.apricusbio.com),
today provided an update regarding ongoing corporate activities and announced
that it expects to file its Quarterly Report on Form 10-Q for the quarter
ended March 31, 2013 with the Securities and Exchange Commission on Friday,
May 10, 2013. As previously announced, the Company will host its first quarter
2013 financial results conference call today, May 10, 2013 at 9:00 a.m. ET.

"Apricus Bio began 2013 with a newly focused corporate strategy aimed at the
commercialization, through partnerships, of its lead product Vitaros® for
erectile dysfunction ("ED") and the development of its lead product candidate
Femprox® for female sexual arousal disorder ("FSAD")," said Richard Pascoe,
Chief Executive Officer of Apricus Bio. "Since the beginning of the year, we
have made important progress in support of that goal, including the successful
divestiture of multiple non-core assets, streamlining of our operations to
better align them with our objectives, and advancement of our regulatory and
commercial strategy for Vitaros® and Femprox®. We continue to believe that the
greatest opportunity for shareholder value creation remains in the global
development and commercialization, through strategic partnerships, of these
lead assets."

Recent Corporate Developments

  *European approval decision for Vitaros® in Europe via the Decentralized
    Procedure ("DCP"). We are currently awaiting a decision regarding the
    approval of Vitaros^® in Europe via the DCP with The Netherlands serving
    as the Reference Member State ("RMS"). In April of 2013, Apricus Bio, in
    consultation with our European commercialization partners, submitted to
    the RMS our response to the Day 120 List of Questions ("LOQ"). This week,
    which marked Day 180 of the regulatory approval process, the RMS confirmed
    that the major nonclinical, clinical and clinical safety issues outlined
    in the Day 120 LOQ have been resolved. While the regulatory review
    process is ongoing, and we remain in active dialogue with the RMS on
    certain remaining matters included in the Day 180 response, we believe
    that the marketing approval process for Vitaros® in Europe remains on
    track for an approval decision on Day 210 of the process assuming there
    are no other interruptions in the review process. If Vitaros® is approved
    by the RMS, our commercialization partners will commence with the National
    Phase approvals in their respective territories. Once those approvals are
    secured on a country-by-country basis, marketing of Vitaros® can then be
    initiated in each country by our commercialization partners. In Europe,
    existing ED products generated over $1 billion in sales in 2012 and
    Apricus Bio believes that a significant portion of the market remains
    untreated or undertreated, which represents a significant commercial
    opportunity for Vitaros®.
  *Commercial Launch of Vitaros® in Canada.Vitaros® is approved in Canada,
    and Apricus Bio licensed Vitaros® to Abbott Canada for commercialization
    of the product in that territory. Abbott remains fully committed to a
    successful launch of the cold-chain version of Vitaros® in Canada in the
    shortest timeframe possible.Abbott is working with their contract
    manufacturer to optimize the product's shelf-life period, which is driven
    by specifications that are applicable only to the product that will be
    sold in Canada, prior to launching the product in that market. As a
    result of these ongoing developments, Abbott has confirmed that a Vitaros®
    launch in Canada in the first half of 2013 will not occur.
  *Femprox® Development Program:Femprox® is our lead product candidate for
    the treatment of female sexual arousal disorder, or FSAD.To date, we have
    completed seven clinical studies with Femprox® including a 100 patient
    Phase 2 study in the U.S. and a 400 patient Phase 3 study in China.The
    data generated from these studies strongly suggests that Femprox® has the
    potential to effectively treat FSAD in a female patient population where
    there are currently no available FDA approved treatment options.Moreover,
    we believe that Femprox® could be the first and only on-demand treatment
    approved for FSAD, where estimates of the market size are on par with that
    found in the erectile dysfunction market. The Company continues to advance
    the Femprox® development program in close consultation with our clinical
    and regulatory advisors.Our near-term goal is to seek confirmatory
    regulatory guidance from the U.S. FDA in the form of an End-of-Phase 2
    meeting.
  *Divestiture of Non-Core Assets: The Company sold its product, Totect^®
    (dexrazoxane HCl), a marketed, injectable treatment for anthracycline
    extravasation, to Biocodex USA ("Biocodex") in March 2013, in line with
    its recently updated corporate strategy. Under terms of the arrangement,
    Apricus Bio received an upfront payment at closing and is eligible to
    receive royalties on net sales of Totect^® by Biocodex through 2016, in
    exchange for Apricus Bio's sale of its commercialization rights to
    Totect^® in North America and South America.

Conference Call Information

The call can be accessed in the U.S. by dialing 877-407-9210 and outside of
the U.S. by dialing 201-689-8049 and asking the conference operator for the
Apricus Bio Conference Call. The conference call will also be webcast live at
http://www.investorcalendar.com/IC/CEPage.asp?ID=17095. The teleconference
replay will be available for one week by dialing in the U.S. 877-660-6853 and
outside of the U.S. by dialing 201-612-7415.Replay Passcode 413843 is
required for playback. The webcast replay will be available for three months.

About Vitaros®

Vitaros®, Apricus Bio's lead product candidate for the treatment of ED, is a
topically-applied cream formulation of alprostadil, a vasodilator, which
directly increases blood flow to the penis, causing an erection. Alprostadil
is a widely accepted alternative to the PDE5 inhibitors for difficult to treat
patients, and Vitaros® is relatively safe and effective, and offers greater
market opportunity due to its patient-friendly form versus both other
alprostadil dosage forms and also relative to oral ED products. With a market
affecting nearly 150 million men worldwide and representing approximately $2.6
billion in revenue – excluding the U.S. – Vitaros® represents a major market
opportunity, particularly as a distinct product that addresses a significant
underserved population.

About Femprox®

Femprox® is a product candidate for the treatment of female sexual arousal
disorder (FSAD).Seven clinical studies have been successfully completed to
date, including one, 98-subject Phase 2 study in the US and a nearly
400-subject Phase 3 study in China.To date, no product has been approved in
the U.S. 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.

About Apricus Biosciences, Inc.

Apricus Biosciences, Inc. (APRI) is a pharmaceutical company that develops and
markets innovative treatments that help large patient populations across
numerous, large-market therapeutic classes including male and female sexual
health.The Company has one approved product, Vitaros®, for the treatment of
erectile dysfunction, which will be marketed in Canada by Abbott Laboratories,
and Femprox®, a product candidate, for the treatment of female sexual arousal
disorder.

For further information on Apricus Bio, visit http://www.apricusbio.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
product Vitaros® for erectile dysfunction , and product candidates Femprox®
for Female Sexual Arousal Disorder among others; to have its product and
product candidates receive additional patent protection and be approved by
relevant regulatory authorities in Europe, the United States and Canada and in
other countries; to successfully commercialize such product and product
candidates and other NexACT^® product candidates and drug delivery technology
through Abbott and its other licensees; to sell its oncology supportive care
business or assets to a third party or parties; to cease funding to its French
subsidiariesand to have such subsidiaries reorganize or liquidate
successfully; and to achieve its other 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 or Lourdes Catala
         Argot Partners
         212-600-1902
         david@argotpartners.com
         lourdes@argotpartners.com

Apricus logo
 
Press spacebar to pause and continue. Press esc to stop.