Apricus Biosciences Provides Corporate Update; Files Annual Report for Quarter
and Year Ended December 31, 2012
Company to Host Conference Call/Webcast Today at 1:00 PM ET
SAN DIEGO, March 18, 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 its Annual Report on Form 10-K for the quarter and year ended December
31, 2012 has been filed with the Securities and Exchange Commission earlier
today. As previously announced, the Company will host its fourth quarter and
year end 2012 financial results conference call today, March 18, 2013 at 1:00
Rusty Ray, Chairman of the Board of Apricus Bio stated: "The Board continues
to believe that the greatest opportunity for shareholder value creation
remains in the development and commercialization, through strategic
partnerships, of the Company's primary pipeline assets, particularly Vitaros®
and Femprox® for male and female sexual health.To realize this value, the
Company's recent activity has been centered on ensuring that our resources are
properly aligned with our corporate objectives.We look forward to a number of
important milestones throughout 2013, including the full commercial launch of
Vitaros® in Canada, regulatory progress with both Vitaros® and Femprox® in key
territories throughout the world, and the announcement of additional strategic
Refocused Strategy on Vitaros® and Femprox®
*Announced new corporate strategy focused on Vitaros® and Femprox®.In
January 2013, Apricus Bio announced its corporate goals for 2013, which
includes focusing its corporate strategy and resources on commercializing
its lead product Vitaros® (alprostadil 0.3% topical cream), for the
treatment of erectile dysfunction ("ED"), and on further developing
through clinical trials its lead product candidate, Femprox® (alprostadil
0.4% topical cream), for the treatment of female sexual arousal disorder
("FSAD").Both products utilize Apricus Bio's proprietary NexACT®
transdermal delivery platform.
*Ceasing of funding of French Subsidiaries.In March 2013, Apricus Bio
announced that, as part of its effort to focus resources on its lead
assets, it intends to cease financing its French subsidiaries, Finesco
SAS, Scomedica SAS and NexMed Pharma SAS.The strategic decision to cease
financing its French subsidiaries follows a decrease in the unit's
operating performance resulting from recently enacted pricing policies
affecting drug reimbursement in France and the subsequent, related loss of
certain contract sales agreements.
*Divestiture of oncology supportive care business.In January 2013, Apricus
Bio announced its plans to seek a buyer for its oncology supportive care
products, which include the rights to Totect® (dexrazoxane for injection)
for the treatment for extravasation from intravenous anthracycline
chemotherapy in the U.S. and the Americas, and the U.S. co-promotion
rights to Granisol® (granisetron HCl oral solution) for the prevention of
nausea and vomiting associated with certain emetogenic cancer therapies
and radiation. Each of these products is now commercially available and
marketed in the U.S. The planned divestiture will allow Apricus Bio to
better align its resources with its stated corporate objectives.
Key Upcoming Milestones
*Commercial Launch of Vitaros® in Canada through Abbott
Laboratories.Apricus Bio is actively supporting Abbott with their
pre-launch efforts, and continues to expect that a full launch will occur
in the first half of 2013.
*European approval decision for Vitaros® in Europe via the Decentralized
Procedure ("DCP").A decision regarding the approval of Vitaros^® in
Europe via the DCP with Netherlands as the Reference Member State is
expected to occur in the first half of 2013, followed by national phase
approvals in each of the major markets of Europe. Marketing of Vitaros^®
can then be initiated in each country by Apricus Bio's commercialization
partners. In Europe, existing ED products currently generate over $1
billion dollar in sales and Apricus Bio believes a significant portion of
the market remains untreated or undertreated.
*Obtain feedback from regulatory agencies and initiate next clinical steps
for Femprox®.In 2013, Apricus Bio expects to announce feedback from its
meetings with Health Canada and the U.S. FDA, as well as its plan for
Femprox^® clinical development going forward.
*Secure additional Vitaros® partnerships.Vitaros^® is now partnered in key
markets around the world, including the U.S., Canada, Germany, the United
Kingdom, Italy, the Gulf countries, certain other countries in the Middle
East and Israel. The Company is looking to secure partnerships in the
remaining major global markets.
Conference Call Information
The call can be accessed in the U.S. by dialing 877-407-8031 and outside of
the U.S. by dialing 201-689-8031 and asking the conference operator for the
Apricus Bio Conference Call. 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 410469 is required for playback. The
conference call will also be webcast live at
http://www.investorcalendar.com/IC/CEPage.asp?ID=170645.The webcast replay
will be available for three months.
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, which successfully completed a nearly 400-subject Phase III study in
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;
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:
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