DGAP-News: Apricus Biosciences Expands Commercial Oncology Offerings Through Agreement With Pediatrx for U.S. Co-Promotion of GRANISOL(R) (Granisetron) Oral Solution and AQUORAL(TM) Spray and Purchase of Non-U.S. Rights to GRANISOL(R)

Apricus Biosciences, Inc.

27.01.2012 14:00
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SAN DIEGO and CALIFON, N.J., 2012-01-27 14:00 CET (GLOBE NEWSWIRE) —
Apricus Biosciences, Inc. (–Apricus Bio– or the –Company–) (Nasdaq:APRI)
(http://www.apricusbio.com) and PediatRx, Inc. (–PediatRx–) (OTCBB:PEDX)
(http://www.pediatrx.com) announced today the execution of a binding term sheet
for (1) the U.S. co-promotion of, and sale of non-U.S. rights to PediatRx–s
Granisol (granisetron HCI) oral solution, the only FDA-approved, oral,
ready-to-use liquid solution of granisetron and (2) the assignment of U.S.
co-promotion rights to AQUORAL, an FDA-cleared, prescription-only spray for the
treatment of Xerostomia (the medical term for dry mouth due to a lack of
saliva).

Granisol is a proprietary formulation of granisetron indicated for the
prevention of nausea and vomiting associated with initial and repeat courses of
emetogenic cancer therapy, including high-dose cisplatin, as well as nausea and
vomiting associated with radiation, including total body irradiation and
fractionated abdominal radiation. The most common side effects observed during
clinical trials of granisetron tablets were headache, muscle weakness
(asthenia), constipation, diarrhea, upset stomach (dyspepsia), and abdominal
pain. For additional safety information about Granisol, please see the –About
Granisol– section below.

AQUORAL is currently being co-promoted by PediatRx on behalf of Bi-Coastal
Pharmaceutical Corp. Xerostomia can be a debilitating medical condition and is
estimated to impact between 35 and 40 million Americans. It is especially
prevalent in patients undergoing various treatments for cancer and those with
Sjogren–s syndrome. It is also common in the elderly and in patients who are
taking prescription medications. For additional safety information about
AQUORAL, please see the –About AQUORAL– section below.

Under the term sheet for the Co-Promotion and Sale Agreement, Apricus Bio will
receive rights to co-promote Granisol and AQUORAL in the U.S., with exclusive
promotion rights in certain states, and will purchase all non-U.S. rights and
intellectual property to Granisol owned or controlled by PediatRx (including
patents, patent applications, trade secrets, know-how, trademarks and trademark
applications) in exchange for a cash payment of $325,000 and a tiered
co-promotion fee equal to a percentage of Apricus Bio–s net operating income
from U.S. sales of GRANISOL. Apricus Bio expects to use the Oncology Supportive
Care sales force and infrastructure, which Apricus acquired with its recent
acquisition of Topotarget USA, Inc. (now Apricus Pharmaceuticals USA, Inc.) in
December 2011, to promote GRANISOL and AQUORAL in the United States. The
potential market in the U.S. for GRANISOL is estimated at approximately $100
million and the potential market in the U.S. for AQUORAL is estimated to be
approximately $50 million.

Apricus Bio also announced that it has signed a non-binding term sheet with
PediatRx under which Apricus Bio may acquire PediatRx through a merger.
Pursuant to the term sheet, Apricus Bio expects to pay approximately $4 million
in stock and assume up to $675,000 in debt of PediatRx. The parties expect to
negotiate a definitive merger agreement on the foregoing terms, which will be
subject to customary closing conditions, including approval by PediatRx Board
and shareholders and by Apricus Bio–s Board and certain termination provisions.
The term sheet includes a payment of $1,000,000, payable in Apricus Bio common
stock, if Apricus elects not to pursue the merger, subject to certain
conditions.

Dr. Bassam Damaj, Chairman, President and Chief Executive Officer of Apricus
Bio, stated, –PediatRx is an ideal strategic fit for Apricus Bio, as it
provides us with two additional marketed oncology products with significant
worldwide sales potential, and, in the US, clear synergy with our Oncology
Supportive Care sales organization from Apricus Pharmaceuticals USA. This
agreement also demonstrates our team–s unwavering focus on execution of the
Apricus Bio growth strategy, which includes adding approved, revenue generating
drugs within our core therapeutic areas to our product portfolio, and
developing, commercializing and partnering products that incorporate our
NexACT(r) technology. We will continue to pursue smart acquisitions, both in the
U.S. and in important international markets that synergize with our commercial
infrastructure and offer the potential to generate substantial revenue over the
long-term.–

–Our agreement with Apricus Bio offers PediatRx the opportunity to
simultaneously accelerate the commercial value of GRANISOL in the U.S.,
monetize the value of GRANISOL in non-U.S. territories and, once consummated,
realize shareholder value through the merger,– said Dr. Cameron Durrant,
Founder, Chairman, President and CEO of PediatRx. –With these agreements,
PediatRx gains access to both a growing commercial organization and, following
approval of the merger, the potential of Apricus Bio and its multifaceted
growth strategy.–

About GRANISOL

Granisetron is indicated for the prevention of:

— Nausea and vomiting associated with initial and repeat courses of
emetogenic cancer therapy, including high-dose cisplatin.
— Nausea and vomiting associated with radiation, including total body
irradiation and fractionated abdominal radiation.

Selected Safety Information

— GRANISOL is contraindicated in patients with known hypersensitivity to the
drug or any of its components.
— QT prolongation has been reported with granisetron. Therefore, GRANISOL
Oral Solution should be used in caution with patients with pre-existing
arrhythmias or cardiac conduction disorders, as this might lead to clinical
consequences. Patients with cardiac disease, on cardio-toxic chemotherapy,
with concomitant electrolyte abnormalities and/or on concomitant
medications that prolong the QT interval are particularly at risk.
— Safety and effectiveness in pediatric patients have not been established.

Please also see the Granisol full prescribing information at:
http://www.pediatrx.com/products/pdf/granisol_pi.pdf

About AQUORAL

AQUORAL is an FDA-cleared, prescription-only device for Xerostomia, the medical
term for dry mouth due to a lack of saliva. AQUORAL is a non-systemic,
non-water based solution and novel formulation of Oxidized Glycerol Triesters
delivered in a convenient pump-spray format to both aid in rehydration and help
heal and restore damage done to the mouth and mucus membranes by a lack of
saliva. Patients should not take AQUORAL if they have a sensitivity or allergy
to corn oil, silicon dioxide, aspartame, or artificial flavorings (citrus).

About Apricus Biosciences, Inc.

Apricus Bio is a San Diego-based, revenue-generating, specialty 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 currently markets
Totect(r)(dexrazoxane HCl), the only drug approved in the US for the treatment of
anthracycline extravasation. Apricus Bio–s current 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.

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 and
http://facebook.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, the ability to consummate the acquisition of
PediatRx, its ability to further develop its and their products and product
candidates, to have its products and product candidates approved by relevant
regulatory authorities, to successfully commercialize such NexACT(r) products and
product candidates, to achieve its development, commercialization and financial
goals in the U.S. and in other countries and to close the acquisition of
PediatRx among other potential future acquisitions of companies and products.
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.

About PediatRx

PediatRx, Inc. (www.pediatrx.com) is a hospital specialty pharmaceutical
company which focuses on treatments for patients suffering from serious
conditions requiring hospitalization. PediatRx trades on the OTCBB under the
ticker symbol PEDX.

PediatRx Forward Looking Statement

This press release contains forward-looking statements. Forward-looking
statements are projections of events, revenues, income, future economics,
research, development, reformulation, product performance or management–s plans
and objectives for future operations. In some cases you can identify
forward-looking statements by the use of terminology such as –may–, –should–,
–anticipates–, –believes–, –expects–, –intends–, –forecasts–, –plans–,
–future–, –strategy–, or words of similar meaning. Forward-looking statements
in this press release include those concerning the potential market in the U.S.
for GRANISOL and AQUORAL andPediatRx–s belief that the transactions with
Apricus will accelerate the commercial value of GRANISOL and AQUORAL in the
U.S., monetize the value of GRANISOL in non-U.S. territories, realize
shareholder value through a merger, gain access to both a growing commercial
organization and, following approval of the merger, the potential of Apricus
Bio.While these forward-looking statements and any assumptions upon which they
are based are made in good faith and reflect current judgment regarding the
direction of the business operations of PediatRx, actual results will almost
always vary, sometimes materially, from any estimates, predictions,
projections, assumptions or other future performance suggested in this press
release. These statements are predictions and involve known and unknown risks,
uncertainties and other factors, including the risk that PediatRx cannot
execute its business plan for lack of capital or other resources, distribution,
partnering or licensing/acquisition opportunities, as well as the risks
described in the periodic disclosure documents filed on EDGAR by PediatRx,
copies of which are also available on the company–s website. Any of these risks
could cause PediatRx or its industry–s actual results, levels of activity,
performance or achievements to be materially different from those expressed or
implied by the forward-looking statements in this press release. Except as
required by applicable law, including the securities laws of the United States,
PediatRx does not intend to update any of the forward-looking statements to
conform these statements to actual results.

CONTACT: Apricus Bio Investor Relations:
David Pitts
Argot Partners
212-600-1902
david@argotpartners.com

PediatRx Inc. Contact:
Research&Business Development
E-mail: info@pediatrx.com

Shareholder Relations
+1 908-975-0753
E-mail: ir@pediatrx.com
News Source: NASDAQ OMX

27.01.2012 Dissemination of a Corporate News, transmitted by DGAP –
a company of EquityStory AG.
The issuer is solely responsible for the content of this announcement.

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Language: English
Company: Apricus Biosciences, Inc.

United States
Phone:
Fax:
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Internet:
ISIN: US9901429525
WKN:

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  apricus-biosciences-expands-commercial-oncology-offerings-through-agreement-with-pediatrx-for-u-s-co-promotion-of-granisol-r-granisetron-oral-solution-and-aquoral-tm-spray-and-purchase-of-non-u-s-righ