Apricus Biosciences Reports Corporate Update
Vitaros® National Phase Approvals Granted in the United Kingdom and Sweden
Company to Host Conference Call/Webcast Today at 9:00 AM ET
SAN DIEGO, Aug. 12, 2013 (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc.
("Apricus Bio" or the "Company") (Nasdaq:APRI) (www.apricusbio.com), today
provided a corporate update.
"Since the beginning of this year, we have continued to focus our efforts on
creating long-term value through our lead product Vitaros® and our lead
product candidate Femprox®," said Richard Pascoe, Chief Executive Officer of
Apricus Bio. "The recent approval of Vitaros® in Europe marked a significant
milestone for Apricus and for our commercial partners Takeda, Sandoz, and
Bracco. Moreover, we recently obtained national phase approvals in the United
Kingdom and Sweden, and we look forward to additional national phase
approvals, continued launch preparations, and the completion of our licensing
activities for Vitaros® later this year."
Mr. Pascoe added:"For Femprox®, our novel female sexual dysfunction
treatment, we look forward to an End-of-Phase 2 meeting with the FDA in late
August, which we expect will provide us with additional clarity regarding the
regulatory path forward for this high-potential program.Both Vitaros® and
Femprox® are key value drivers for our shareholders, and as such we are
focused on flawless execution of the key initiatives that will lead to
successive Vitaros® product launches and the development of a successful
Femprox® clinical program."
*European Approval Decision for Vitaros®. In June 2013, Apricus Bio
announced that its marketing application for Vitaros®, indicated for the
treatment of patients with erectile dysfunction ("ED"), was approved
through the European Decentralized Procedure ("DCP").Under the DCP, the
Company filed its application for marketing approval designating
Netherlands as the Reference Member State ("RMS") on behalf of nine other
European Concerned Member States ("CMS") participating in the procedure.
The CMS includes France, Germany, Italy, UK, Ireland, Spain, Sweden,
Belgium and Luxembourg.
*National Phase Approvals Granted in the UK and Sweden. Last week, Apricus
Bio was granted national phase approvals for Vitaros® in the UK and
Sweden.The Company continues to work independently as well as with its
commercialization partners to obtain the country-by-country national phase
approvals for the remaining CMS regions. Our regulatory efforts along with
the actions taken by our existing European partners continue to move
successfully toward making Vitaros® ready to launch in each of the
included territories across Europe.
*Vitaros® Partnering Process on Track.Concurrent with the EU approval of
Vitaros®in June 2013, Apricus Biolaunched a comprehensive partnering
process with the goal of licensing Vitaros® in the remaining un-partnered
territories in Europe, Latin America, and North Africa.Our key partnering
objectives for Vitaros® are to maximize the total deal value for the
asset, expand existing Vitaros partnerships wherever possible, and select
partners who have a strong clinical, regulatory and commercial presence in
their respective territory.We are reviewing bids recently received from
multiple interested parties for the available territories and we expect to
complete our Vitaros® partnering process in the fourth quarter of this
*Femprox® Development Program. Femprox® is Apricus Bio's lead product
candidate for the treatment of female sexual interest/arousal disorder, or
FSIAD. An End-of-Phase 2 meeting with the U.S. Food and Drug
Administration ("FDA") is currently scheduled for late August 2013.
Following receipt of official FDA meeting minutes, Apricus Bio will be
able to provide further clarity regarding the Femprox® regulatory pathway
in the U.S. To date, the Company has completed seven clinical studies with
Femprox® including a 100 patient Phase 2 study in the U.S. and a 400
patient proof of concept study in China. The data generated from these
clinical studies strongly suggest that Femprox® has the potential to
effectively treat a patient population where there are currently no
available FDA approved treatment options.
*Completed $17.1 Million Public Offering.In May 2013, Apricus Bio
completed an underwritten public offering of its common stock and warrants
for gross proceeds totaling approximately $17.1 million, the net proceeds
of which the Company intends to use for general corporate purposes,
including various development and approval efforts related to Vitaros® and
*Two Vitaros® Poster Presentations at Scientific Meetings.In May 2013,
John P. Mulhall, MD, Director of the Male Sexual and Reproductive Medicine
Program at Memorial Sloan-Kettering Cancer Center, presented results from
an analysis of existing Phase 3 data for Vitaros® at the American
Urological Association Annual Meeting.The results demonstrated that
Vitaros® was well tolerated and improved erections in men who were
previously unresponsive to PDE-5 inhibitors.In June 2013, the Company
presented results from an additional analysis of existing Phase 3 data at
the International Symposium on Prostate, Androgens and Men's Sexual
Health, which demonstrated increased efficacy and decreased adverse events
with longer-term use of Vitaros®.
Cash and cash equivalents totaled $24.8 million as of June 30, 2013, compared
to $15.1 million as of December 31, 2012.Based upon Apricus Bio's current
business plan, the Company believes it has sufficient cash reserves to fund
its ongoing operations into late 2014. The Company expects to release its
second quarter 2013 financial results later this week.
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 conference call will also be webcast live at
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 418593 is
required for playback. The webcast replay will be available for three months.
Vitaros^® has been approved for the treatment of Erectile Dysfunction ("ED")
by the European Health Authorities and by Health Canada.Vitaros^® is a
topically-applied cream formulation of alprostadil, a vasodilator, combined
with our proprietary permeation enhancer DDAIP.HCL, which directly increases
blood flow to the penis, causing an erection. Alprostadil is a widely accepted
alternative to the PDE-5 inhibitors for difficult to treat patients, and
Vitaros^®, which was determined to be safe and effective by the European
Health Authorities and previously by Health Canada, offers greater market
opportunity due to its patient-friendly form versus other alprostadil dosage
forms and also relative to oral ED products. With nearly 150 million men
worldwide who suffer from erectile dysfunction and an ED market size of
approximately $1 billion in revenue in Europe alone, Vitaros^® represents a
major market opportunity for Apricus Bio and its commercial partners given its
unique product profile and its potential to treat a large underserved
Femprox^® is a product candidate for the treatment of female sexual
interest/arousal disorder (FSIAD). Seven clinical studies have been
successfully completed to date, including one, 98-subject Phase 2 study in the
US and a nearly 400-subject proof of concept study in China. To date, no
product has been approved in the U.S. to treat FSIAD, a persistent or
recurring inability to attain or maintain adequate sexual excitement, causing
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 is now approved in Europe and Canada and will be
commercialized by Apricus Bio's marketing partners, which include Abbott
Canada, Takeda Pharmaceuticals International GmbH, Sandoz, and Bracco SpA.
Femprox^®, the Company's product candidate for the treatment of female sexual
arousal disorder, has successfully completed a nearly 400-subject
For further information on Apricus Bio, visit http://www.apricusbio.com.
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 candidate 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:
David Pitts or Lourdes Catala
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