Apricus Biosciences, Inc.
09.09.2011 20:51
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SAN DIEGO, 2011-09-09 20:51 CEST (GLOBE NEWSWIRE) --
Apricus Biosciences, Inc. ('Apricus Bio') (Nasdaq:APRI)
(http://www.apricusbio.com) announced today that Dr. Bassam Damaj, Chairman,
President and Chief Executive Officer, will present an overview of its
wholly-owned subsidiary, NexMed (USA), Inc.'s Rx and Consumer Healthcare
Divisions, at the 11th Annual Biotech in Europe Investor Forum on September 14,
2011 at 12:15 pm CEST, at the Hilton Zurich Airport Hotel in Zurich,
Switzerland.
Dr. Damaj will provide an overview of Apricus Bio's Rx Division, including its
partnership plans for Vitaros(r), which was approved for marketing in Canada as
a
topical treatment for erectile dysfunction; the submission of regulatory
filings for this product in the European Union and in Switzerland and the
Company's planned submissions in certain Latin American countries. He will also
discuss the fact that the Company is currently in negotiations for both
individual and bundled partnership agreements relating to Canada and Europe,
and is proceeding with manufacturing, scale-up and commercial batches of the
drug for Canada. In addition, Dr. Damaj will discuss the regulatory progress of
MycoVa(tm) (being developed for toe nail fungus, excluding Tinea Pedis) and its
current commercial partnership efforts and progress.
An overview of the status of the Company's later stage Rx Division pipeline
will also be provided, including: Femprox(r) for female sexual arousal disorder,
PrevOnco(r) for human hepatocellular carcinoma (liver cancer) and RayVa(tm) for
Raynaud's Syndrome.
Dr. Damaj's presentation will also include a review of the Company's Consumer
Healthcare Division, which will focus on introducing drugs and medical devices
in the U.S., Canada and other countries to consumers through: (1) the
over-the-counter ('OTC') monograph compliance and similar Canadian OTC
processes, (2) the 510(k) clearance procedure in the U.S. for certain topical
and wound healing products regulated as medical devices, and similar
international regulatory processes and (3) the abbreviated new drug application
('ANDA') approval procedure in the U.S. for generic drugs, and similar
processes in other countries. In each of these instances, the Company will seek
to combine its proprietary NexACT(r) technology, if found as an acceptable
excipient by the U.S. Food and Drug Administration ('FDA'), with another drug
or ingredient.
Management will also discuss its plans to introduce its OTC products into other
countries, such as Canada, Europe and the Middle East upon receipt of
regulatory approval from relevant authorities in those countries.
Apricus Bio is planning to utilize the FDA's 510(k) route to file for clearance
for one of its wound healing products, now in development. Pursuant to the
510(k) process, the FDA has cleared certain topical creams that are considered
by the agency to be medical devices. This medical device designation means that
there is no active drug in the formulation. To the Company's knowledge, over
the last few years, the FDA has cleared the following drugs through the 510(k)
process: Atopiclair(r) (Graceway Pharmaceuticals), Eletone(r) (Ferndale
Healthcare)
and MimyX(r) (Stiefel Laboratories). These products are intended for the
treatment of various dermatoses and are known as barrier creams because they
help keep the skin hydrated, thus helping the healing process.
Apricus Bio is also considering utilizing the ANDA process in the U.S. for
generic drugs that are exempt from having to conduct clinical trials
(biowaiver) such as minoxidil, the active ingredient in Rogaine(r) (Pfizer), and
to seek approval for drugs that have generic competitors and can integrate
DDAIP, the main ingredient in its NexACT(r) technology, if it is found an
acceptable excipient by the FDA.
About Apricus Biosciences, Inc.
Apricus Bio, a San Diego-based, revenue-generating, biopharmaceutical company,
has leveraged the flexibility of its clinically-validated NexACT(r) drug
delivery
technology to enable multi-route administration of new and improved compounds
across numerous therapeutic classes.
Revenues and growth are driven from out-licensing of this technology for the
development and commercialization of such compounds to pharmaceutical and
biotechnology companies worldwide. In addition, the Company is seeking to
monetize its existing Rx Division product pipeline, including its first
product, Vitaros(r), approved in Canada for the treatment of erectile
dysfunction, which is currently expected to be available on the Canadian market
in 2011, as well as compounds in development from pre-clinical through Phase
III, currently focused on Sexual Dysfunction, Oncology, Dermatology,
Autoimmune, Pain, Anti-Infectives, Diabetes and Cosmeceuticals among others.
The Company is also developing its Consumer Healthcare Division by developing a
number of drugs that utilize the Company's NexACT(r) technology to comply with
the FDA's over-the-counter ('OTC') requirements, be cleared as 510(k) topical
creams that are considered to be medical devices or approved as Abbreviated New
Drug Applications ('ANDAs') as generic drugs. The Company will also seek to
market such drugs through these similar procedures in foreign countries.
For further information on Apricus Bio, visit http://www.apricusbio.com and for
information on its subsidiary please visit 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, its ability to receive issued patents on its
NexACT(r) technology and products, develop such patented technology into product
candidates, have its Rx Division products and product candidates such as
Vitaros(r), Femprox(r), MycoVa(tm), RayVa(tm) and PrevOnco(tm) approved by
relevant
regulatory authorities and its Consumer Healthcare Division products either
approved or cleared by relevant regulatory authorities or be in compliance with
appropriate regulatory requirements, to successfully manufacture and
commercialize such Rx Division products in the U.S., Canada, Europe and in
other countries along with its Consumer Healthcare Division products including,
over-the-counter products ('OTC'), 510(k) clearances or Abbreviated New Drug
Applications ('ANDAs') and product candidates 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 Biosciences, Inc.
Edward Cox, V.P.
Corporate Development & Investor Relations, Apricus Bio, Inc.
(858) 848-4249
ecox@apricusbio.com
Apricus Bio Investor Relations
Paula Schwartz
Rx Communications Group, LLC
(917) 322-2216
pschwartz@rxir.com
News Source: NASDAQ OMX
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Language: English
Company: Apricus Biosciences, Inc.
United States
Phone:
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Internet:
ISIN: US9901429525
WKN:
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DGAP-News: Apricus Biosciences to Provide Overview of Rx and Consumer Healthcare Divisions at the 11th Annual Biotech in Europe Investor Forum
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