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 Sjögren'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® 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® technology.
Apricus Bio currently markets Totect®(dexrazoxane HCl), the only
drug approved in the US for the treatment of anthracycline
extravasation. Apricus Bio's current 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.
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® 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