DGAP-News: Photo Release -- Apricus Biosciences Announces FDA Clearance for Its First Anti-Fungal OTC Drug (Tolnaftate-D(TM)) Containing NexACT(R) Technology
ID: 464105
18.08.2011 15:00
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DDAIP Now Listed on U.S. Monograph for OTC Products
SAN DIEGO, 2011-08-18 15:00 CEST (GLOBE NEWSWIRE) --
Apricus Biosciences, Inc. ('Apricus Bio' or the 'Company') (Nasdaq:APRI)
(http://www.apricusbio.com) announced today that its wholly owned subsidiary,
NexMed USA, has received clearance from the U.S. Food and Drug Administration
('FDA') to market its first anti-fungal, over-the-counter ('OTC') drug,
Tolnaftate-D(tm), containing the Company's NexACT(r) technology.
A photo accompanying this release is available at
http://www.globenewswire.com/newsroom/prs/?pkgid=10161
'This is the first approval by the FDA of a drug containing Apricus Bio's
NexACT(r) drug delivery technology, and as such, is a very important milestone
for us,' explained Dr. Bassam Damaj, Chairman, President and Chief Executive
Officer of Apricus Bio. 'In particular, we believe this is a crucial validation
of our technology. Our expectation is that this may represent just the first of
many such OTC drugs containing our proprietary technology.'
The active ingredient in the cleared OTC drug, tolnaftate, is an already
approved anti-fungal agent, which can be sold as a cream, powder, spray or
liquid aerosol, and is currently used to treat jock itch, athlete's foot and
ringworm. It is sold under several third party brand names, most notably
Tinactin(r) (Merck) and Lamisil AF(r) (Novartis), among others.
Apricus Bio's Tolnaftate-D(tm) incorporates NexACT(r), the Company's proprietary
drug delivery technology, which transiently loosens the tight junction between
the cells of the sealed skin to allow more permeation.
With the approval of this drug, DDAIP, the mainstay of the Company's NexACT(r)
technology, is now listed as an excipient in an approved drug and is part of
the U.S. monograph (the underlying FDA regulatory document). As such, DDAIP can
be combined with active ingredients listed in the monograph to develop a
greater number of OTC products, which can be sold in the U.S.
'We have been working on obtaining such status for over eight months and we
believe that the cleared anti-fungal drug containing DDAIP and tolnaftate may
be the first of many such OTC drugs that we and our partners will market and
sell,' stated Dr. Damaj. 'In addition, being added to the monograph permits us
to work with other companies in developing combinations of our NexACT(r)
technology with the potentially hundreds of active ingredients listed in the
monograph and to develop their proprietary drugs using NexACT(r) at the
concentration used in our approved Tolnaftate-D(tm) OTC drug.'
According to the FDA, OTC products can be marketed under the authority of an
approved product-specific new drug application ('NDA'), abbreviated NDA
('ANDA') or under and OTC drug monograph. Unlike NDAs, which are based on drug
products, monographs specify the active ingredients that can be contained
within OTC drug products. In addition to specifying the active ingredients, the
OTC monographs contain information regarding the permitted concentrations of
active ingredients, dosage limits, indications, and other requirements for
legal marketing under monograph status. To view the current U.S. monographs for
OTC products, pleasego to
http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDER/UCM135688.pdf (to
view by Active Ingredient), or
http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDER/UCM135691.pdf (to
view by Monograph Category). To view the current approval listing, please go to
http://dailymed.nlm.nih.gov and type Tolnaftate in the search index.
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 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.
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 products and product candidates such as Vitaros(r) approved
by relevant regulatory authorities, to successfully commercialize such products
including over-the-counter products ('OTC') 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.
The photo is also available at Newscom, www.newscom.com, and via AP
PhotoExpress.
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
18.08.2011 Dissemination of a Corporate News, transmitted by DGAP -
a company of EquityStory AG.
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:
End of AnnouncementDGAP News-Service
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Themen in dieser Pressemitteilung:
photo-release
apricus-biosciences-announces-fda-clearance-for-its-first-anti
fungal-otc-drug-tolnaftate
d-tm-containing-nexact-r-technology
Unternehmensinformation / Kurzprofil:
Datum: 18.08.2011 - 15:00 Uhr
Sprache: Deutsch
News-ID 464105
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