SAN DIEGO, CA, and CALIFON, NJ, Jan. 27,
2012 /PRNewswire/ - 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 and PediatRx'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.
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
SOURCE PediatRx Inc.