Apricus Biosciences, Inc. ("Apricus Bio" or the "Company")
(Nasdaq:APRI) announced today a corporate update to address Company
activities and expected near-term events.
Dr. Bassam Damaj, Chairman, President and Chief Executive
Officer of Apricus Bio, stated, "We believe that 2012 will be
the most important in Apricus Bio's history so far." Dr. Damaj
informed shareholders, "The Company is now shifting from a
development stage company with little institutional ownership to a
commercial revenue-generating global operation with hopefully
long-term institutional investment support. The Company also
expects to book approximately $4 million from Vitaros®
collaborations signed so far this year. We believe that signing two
major collaborations in the first quarter of this year is a good
indication that the Company plans to have major revenues from
Vitaros® collaborations and the beginning of product sales this
year."
The addition of a commercial oncology sales force with three
marketed drugs to sell in the U.S. is a major step for the Company
in its efforts to start generating its own direct sales. "It's an
important shift for the Company to begin selling our drug products
ourselves in some territories as it can drive more revenue growth
and places many of our commercialization timelines under our own
control," Dr. Damaj stated. "Oncology supportive care is our
first step in the U.S. with a sales force. Our goal is to
expand into other focused disease areas moving forward."
"Apricus Bio's recently announced, institutionally-focused
financing, now provides our specialty pharmaceutical company with
the institutional investment support necessary to grow to the next
level," Dr. Damaj continued. "Apricus Bio looks forward to
much broader investment coverage by an expanded range of financial
analysts in 2012."
Apricus Bio is expanding the ownership of its stock from a
predominantly retail base to becoming more institutionally
held. "Such financing has provided our Company with the
important funding resources to directly grow Apricus Bio's value by
filing for commercialization authorization for up to five drug
products in 2012 and 2013; to launch newly acquired products; and
to continue to acquire additional, revenue-producing drug
products," he explained.
NexACT® Platform Products:
Vitaros®
Vitaros® (alprostadil), Apricus Bio's treatment for erectile
dysfunction, is now partnered in the U.S., Canada, Germany, certain
countries in the Middle East, the Gulf countries, Israel and
Italy. Most recently, the Company entered into (1) an
exclusive licensing agreement with Abbott Laboratories Limited
("Abbott") to market Vitaros® in Canada, who plan to launch the
product in Canada in 2012 and (2) Sandoz, a division of Novartis,
for Germany. The Company's recent deal with Sandoz-Novartis is an
important partnership to Apricus not just for its large size but
also for us being able to bring back Novartis as a partner which
brings back the confidence in our NexACT® technology and the drugs
based on it.
Apricus Bio's near term focus for Vitaros® is to commence sales
in Canada this year though its commercial partner Abbott, continue
to generate revenue from partnerships for the product with major
pharma, including some which the Company intends to enter into and
announce in the near term.
The Company may also market the drug itself in certain
territories in Europe as the company expands its sales force and
presence.
Femprox®
Femprox®, a topical cream for the treatment of female sexual
arousal disorder ("FSAD"), has been the subject of nine clinical
studies completed to date, including the only successfully
completed Phase III and most advanced product in development for
the indication.
The Company expects to have guidance from the health agencies in
the U.S., Europe and Canada by the end of Q2 2012.
Despite several setbacks in a similar space by third parties on
other drugs in this space recently, we are still the most advanced
and the only Company that ran a successful 400 patient Phase III
clinical trial in FSAD and achieved statistical significance on the
primary and secondary endpoints. The Company believes Femprox® is
unique not only because of its direct and local mechanism of action
and safety profile, but also because of its relatively high
response rate in its successful Phase III clinical trial.
Apricus Bio also feels that this is a potential blockbuster
product, which some have estimated to be a $4 billion dollar space
with no approved products on the market yet.
MycoVa™
MycoVa™, a topical treatment for onychomycosis (nail fungal
infection) is the Company's second partnered pipeline product
utilizing Apricus Bio's proprietary NexACT® technology. In
December 2011 and January 2012, the Company completed two licensing
agreements granting exclusive marketing rights for MycoVa™ with
Stellar Pharmaceuticals, Inc. in Canada and Elis Pharmaceuticals in
certain countries in the Middle East and the Gulf Countries
(excluding Israel).
The Company's regulatory strategy in the U.S. is to use its
human blood and nail bioequivalency study against Lamisil® cream in
conjunctions with the secondary endpoints from our 3 Phase III
trials and file for approval using the 505b2 path. In Europe, the
company intends to file for approval using the non-inferiority
analysis achieved against Loceryl® in our European phase III
trial. Lamisil® is a registered trademark of Novartis and
Loceryl® is a registered trademark of Galderma.
The Company expects to have guidance from the health agencies in
the U.S., Europe and Canada by the end of Q2 2012.
Apricus Bio's Commercial Sales Force: Oncology
Supportive Care Marketed Products.
The Company launched its commercialization arm beginning in
oncology supportive care in December 2011 with the acquisition of
Topotarget USA, Inc. (since renamed Apricus Pharmaceuticals USA,
Inc.) , gaining a pre-existing sales infrastructure, sales team,
and a revenue-generating product with what the Company believes to
be a strong future growth potential and additional second use
label. The oncology supportive care product platform was expanded
through an agreement with PediatRx, Inc. in January, with
co-promotion rights to two additional products in this space,
Granisol™ and Aquoral™.
Totect®
Totect® (dexrazoxane HCl) is for the treatment
of anthracycline extravasation, the leakage of chemotherapies from
the vein into the surrounding healthy tissue. Totect® is the only
proven protection against the potentially devastating effects of
anthracycline extravasation. The Company also intends to grow the
market potential for this product by filing a supplemental NDA this
year for a second use of cardiac protection for Doxorubicin use
based on the trials the Company has already run. The Company
intends to further monetize Totect® by partnering the product
throughout Canada and Latin America. There are presently 3,500
cancer centers in the U.S., all of which should eventually carry
Totect. There are approximately 550,000 anthracycline infusions
each year in the U.S. with estimates of extravasations calculated
as high, occurring 1% of the time, and potential uses for the
second label if granted by the FDA.
Granisol™
Granisol™ (granisetron) is the only
FDA-approved, oral, ready-to-use liquid solution of granisetron
oral solution for prevention of nausea and vomiting associated with
emetogenic cancer therapy and radiation. In addition to U.S.
co-promotion rights, Apricus Bio purchased non-U.S rights to
Granisol™. The present oral solution market for the anti-emetics is
approximately $70 million in the U.S. with the overall oral market
for anti-emetics above $3 billion.
Aquoral™
Aquoral is an FDA-cleared, prescription-only spray for the
treatment of Xerostomia (the medical term for dry mouth due to a
lack of saliva). Xerostomia is caused by oncology, central nervous
system drugs. The Company intends to detail the drug for the
oncology use through its sales force and partner the CNS use.
The advantage of an oncology support sales force is that the
same salesperson can help sell multiple products to the same end
user which in our case is the oncology supportive care nurse and
the hospital pharmacist who stocks the product. Chemotherapy and
radiation therapy may result in side effects and often the same
patients can experience extravasation (therefore requiring
Totect®), nausea (therefore requiring Granisol™) and Xerostomia
(therefore requiring Aquoral™) in addition to pain, mucositis,
dermatitis in addition to other potential side effects.
The Company additionally has announced in January of this year
that it is in negotiations to acquire PediatRx and it currently
expects to have approximately 25 supportive care sales force in
addition to an additional 100 on-call nurses and a pharmacist
call-center.
The Company is also currently in negotiations to acquire
additional products for this sales force
Other Specialty Pharmaceutical
Transactions.
NitroMist™:
Apricus Bio further expanded its commercial arm worldwide with
the acquisition of ex-U.S. rights to NitroMist™, an
FDA-approved and marketed nitrate vasodilator indicated for acute
relief of an attack or acute prophylaxis of angina pectoris (chest
pain) due to coronary artery disease (narrowing of the blood
vessels that supply blood to the heart). In February 2012,
NovaDel Pharma Inc. sold Apricus Bio the rights to sell and license
NitroMist™ in territories outside of the United States, Canada and
Mexico. NovaDel has estimated the worldwide market for NitroMist™
to be more than $200 million. The Company intends to file for
marketing authorization in Europe and certain other countries in
the acquired territory in 2012 and has already initiated commercial
partnering discussions.
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
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 and their products and product candidates, to
have its products such as Vitaros®, Femprox® and MycoVa™ 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 such as the booking of $4 million for Vitaros®
partnerships to date and the further commercialization of Totect®,
Granisol™ and Aquoral™ and to achieve its other regulatory,
commercial and financial goals in the U.S. and in other countries.
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
Argot Partners
212-600-1902
david@argotpartners.com
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