Apricus Biosciences, Inc.
19.10.2011 15:30
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SAN DIEGO, 2011-10-19 15:30 CEST (GLOBE NEWSWIRE) --
Apricus Biosciences, Inc. ('Apricus Bio' or the 'Company') (Nasdaq:APRI)
(http://www.apricusbio.com) announced today that the Korean Patent Office
recently issued a Notice of Allowance to grant a patent for the Company's
development of a topical cream utilizing vasoactive prostaglandin E to treat
premature ejaculation ('PE'), When issued, the patent, entitled, 'Compositions
and Methods for the Treatment of Premature Ejaculation,' will provide Korean
patent protection until March 2024. It is one in a series of issued patents and
pending applications that Apricus Bio owns in the male sexual dysfunction field
utilizing its proprietary NexACT(r) technology, which includes its Vitaros(r)
product to treat erectile dysfunction ('ED'), among others in research and
development.
Commenting on today's news, Dr. Bassam Damaj, President and Chief Executive
Officer of Apricus Bio, commented, 'We are very pleased with this patent
allowance in South Korea for the use of vasoactive prostaglandin E to treat PE.
This allowed patent includes the same pharmaceutical composition as Vitaros(r),
combined with a local anesthetic. We are aggressively seeking marketing
approval from various regulatory authorities and pursuing partnership
transaction applications for Vitaros(r) for erectile dysfunction, and are also
developing related products utilizing our NexACT(r) technology that may add to
the value of our existing portfolio of drugs to treat various types of sexual
dysfunction. In addition to the issuance of this new Korean patent, we are
actively seeking patent protection for this PE application in the U.S. and in
other key countries.'
Vitaros(r) has been approved by Health Canada for marketing and sales for
patients with ED and the Company has filed for marketing approval for the drug
for this indication in the European Union and Switzerland. Vitaros(r) is a
topical cream that incorporates alprostadil, a well-recognized vasodilator
currently marketed by other companies as an injectable product or an
intra-urethral insert. The drug has been studied in over 3,300 patients,
including difficult to treat populations, such as those with diabetes, cardiac
problems, sildenafil (Viagra(r)) failures and post prostatectomy patients.
Vitaros(r) has demonstrated clinical efficacy and an excellent safety profile
versus the currently approved oral therapies, and is not contraindicated for
patients taking alpha blockers or nitrate medication. Viagra(r) is a registered
trademark of Pfizer, Inc.
Apricus Bio is currently studying the use of vasoactive prostaglandin E,
combined with and without local anesthetics, to develop a topical cream to
treat PE. To date, the Company has completed three clinical studies for this
application, including two single-blind studies and one double-blind study.
The Company's PE patent portfolio currently consists of four issued patents
(Australia, Singapore, Japan and soon-to-be Korea) and eight pending
applications (the U.S., Canada, Europe, Mexico, Brazil, China, Hong Kong and
Israel).
According to Datamonitor 2010, 'Premature ejaculation is a commonly yet poorly
understood and defined male condition. Prevalence estimates vary greatly from
4% to 29% as stated by a study done by Simons and Carey (2001), according to
the different definitions used. The disorder is currently severely undertreated
and off-label prescription of selective serontonin reuptake inhibitors
('SSRIs') is the most common treatment pathway in the seven major markets.'
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, can 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. Information may
also be found 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 conduct or part with other
companies to conduct research that demonstrates the effectiveness of its
NexACT(r) drug delivery technology to enhance the delivery of drugs through
various routes of administration such as transdermal, transbuccal among others,
its ability to receive issued patents on its NexACT(r) technology and products,
develop such patented technology into product candidates such as Vitaros(r) for
premature ejaculation, have its Rx Division products and product candidates
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 along with its Consumer
Healthcare Division products 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.
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
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ISIN: US9901429525
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DGAP-News: Apricus Biosciences Announces Issuance of Korean Patent, Expanding Its Patent Portfolio for Its Topical Cream to Treat Premature Ejaculation
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