Apricus Biosciences Announces Issuance of Korean Patent, Expanding Its Patent Portfolio for Its Topical Cream to Treat Premat...
October 19 2011 - 9:30AM
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®
technology, which includes its Vitaros® 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®, combined
with a local anesthetic. We are aggressively seeking marketing
approval from various regulatory authorities and pursuing
partnership transaction applications for Vitaros® for erectile
dysfunction, and are also developing related products utilizing our
NexACT® 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® 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® 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®) failures and post
prostatectomy patients. Vitaros® 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® 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® 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®,
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®
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® 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® technology and
products, develop such patented technology into product candidates
such as Vitaros® 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.
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
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