DGAP-News: Apricus Biosciences Announces That Its NexACT(R) Partner Exodos Life Sciences Has Completed Its pre-IND Meeting With the FDA
ID: 520559
15.11.2011 15:30
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Exodos Moves Closer to Filing a U.S. Investigational New Drug Application for
Its Topically-Applied Formulation of Ketoprofen for Pain Relief
SAN DIEGO, 2011-11-15 15:30 CET (GLOBE NEWSWIRE) --
Apricus Biosciences, Inc. ('Apricus Bio' or the 'Company') (Nasdaq:APRI)
announced today that its NexACT(r) out-licensing partner, Exodos Life Science
Limited Partnership ('Exodos'), a privately-held company located in Chapel
Hill, North Carolina, has completed a successful pre-IND ('Investigational New
Drug Application') meeting with the U.S. Food and Drug Administration ('FDA')
regarding its plan to conduct clinical trials to establish the safety and
effectiveness of its patented, topical painkilling drug, ELS115, containing
NexACT(r) technology licensed from Apricus Bio.
Specifically, the meeting was a successful milestone in Exodos' effort to file
an IND with the FDA for a topical, non-steroidal, anti-inflammatory drug
('NSAID'), combining the existing drug, ketoprofen, with Apricus Bio's NexACT(r)
technology. The NexACT(r) technology is designed to permit drugs to be delivered
through the skin with enhanced absorption and bioavailability.
Exodos licensed Apricus Bio's NexACT(r) technology for the topical delivery of
drugs to treat pain and inflammation. 'We are very encouraged by the progress
achieved thus far by Exodos, for its topical NSAID product, which the company
currently expects to be ready for IND filing by mid-2012,' said Bassam Damaj,
Ph.D., President and Chief Executive Officer of Apricus Bio. 'The out-licensing
of our NexACT(r) technology has allowed Exodos to move more quickly toward its
clinical goals for its first product in this important disease area.'
Apricus Bio noted that Exodos is expected to be the first NexACT(r) technology
out-licensing partner to file for approval to initiate a human clinical
program.
About the Exodos NSAI Drug ELS115
NSAIDs, such as ibuprofen and ketoprofen, have been in use for decades,
successfully reducing pain and inflammation for millions of patients. However,
while these drugs work well in pill form, there are many conditions for which
the ability to target the drug in a localized manner, such as for treatment of
arthritis in the hands, may be advantageous. To date, the challenge has been
that these drugs exhibit poor skin penetration, making such efforts to deliver
them locally, unsuccessful.
This challenge may be solved by Apricus Bio's NexACT(r) technology, which is
intended to open up the tight junctions between skin cells. As a result,
certain drugs attached to proprietary NexACT(r) chemicals may pass through the
skin to reach their targets. Exodos' drug, ELS115, a combination of NexACT(r)
technology and ketoprofen, may provide an effective and safe treatment of
mild-to-moderate peripheral pain. If the clinical studies establish that the
drug is safe and can be delivered through the skin right where it is needed,
the product may be an important alternative for patients with localized pain
and who may also: (i) have a history of gastrointestinal, kidney or liver
problems which may be exacerbated by drugs taken in pill form, (ii) be
geriatric or pediatric patients, and/or (iii) patients at risk for drug
interactions, if the levels of circulating ketoprofen are very low to
non-existent. Exodos selected ketoprofen as the active ingredient for its drug
because ketoprofen has a decades-long record of safe clinical use.
About Exodos Life Science Partners
Exodos Life Sciences is a privately-held pharmaceutical development company
that focuses on advancing new product concepts through the 505(b)(2) process to
early clinical proof of principle, followed by asset (project) sale. Exodos has
adopted a semi-virtual model to control costs and advance projects by utilizing
its experienced team and on-call external pharmaceutical experts and partners.
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 existing 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
505(b)(2) New Drug Applications ('NDAs') or 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 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, its and its partners such as Exodos Life Science
Partners among others ability to further develop its and their products such as
ELS115 for pain and other products and product candidates, to have its and
their products and product candidates approved by relevant regulatory
authorities, to successfully commercialize such products and product candidates
and to achieve its and their 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.
Investor Relations&Corporate Development
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
15.11.2011 Dissemination of a Corporate News, transmitted by DGAP -
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The issuer is solely responsible for the content of this announcement.
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Language: English
Company: Apricus Biosciences, Inc.
United States
Phone:
Fax:
E-mail:
Internet:
ISIN: US9901429525
WKN:
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Datum: 15.11.2011 - 15:30 Uhr
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