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DGAP-News: Apricus Biosciences Strengthens Vitaros(R) and Nexact(R) Patent Estate With Two New Patent Allowances
ID: 646802
(firmenpresse) - Apricus Biosciences, Inc.
25.05.2012 19:20
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SAN DIEGO, 2012-05-25 19:20 CEST (GLOBE NEWSWIRE) --
Apricus Biosciences, Inc. ('Apricus Bio' or the 'Company') (Nasdaq:APRI)
(http://www.apricusbio.com), announced today that the Canadian Intellectual
Property Office issued a Notice of Allowance for a Canadian patent on certain
methods of manufacture for the Company's platform NexACT(r) drug delivery
technology.
Specifically, the patent covers the synthesis of Dodecyl 2-(N,
N-Dimethylamino)-Propionate (DDAIP) by a transesterification chemical process.
DDAIP opens up the tight junctions between cells, allowing drugs to be
delivered to the bloodstream.
The patent application (No. 2,706,680), entitled 'Crystalline Salts of Dodecyl
2-(N, N-Dimethylamino)-Propionate, is a divisional application of the already
issued Canadian Patent No. 2,338,139 bearing the same title and covering
crystal salts of DDAIP. When issued, this patent will protect this method of
manufacture of DDAIP in Canada, and provides patent exclusivity to May 2020.
The transesterification approach to synthesizing DDAIP represents an advance in
the manufacturing process of this technology. The resulting product contains
relatively lower levels of by-products and unreacted reactants, which are
undesirable and difficult to remove by conventional methods. The Company
expects this method to bring significant cost savings for the finished product.
This will be the 17th patent granted for this technology worldwide, with two
applications pending in this patent family.
In addition, the New Zealand Intellectual Property Office issued a Notice of
Acceptance for New Zealand patent application number 576,242, entitled
'Stabilized Prostaglandin E Composition,' which claims formulations of
Vitaros(r), Apricus Bio's lead product candidate for the treatment of erectile
dysfunction. When issued, this patent will grant exclusive rights to certain
pharmaceutical compositions of Vitaros(r)--including its room temperature
formulation in New Zealand. It will provide patent exclusivity until October
2027.
'These new patent allowances serve to further strengthen our global
intellectual property positions,' said Bassam Damaj, President and Chief
Executive Officer of Apricus Bio. 'We continue to pursue an aggressive patent
strategy that we believe will protect the DDAIP compound and method of
manufacture including those relating to our more advanced room temperature
formulations, and we will meaningfully expand the market exclusivity of our
products in important territories.'
Apricus Bio currently owns approximately 144 issued patents and 143 patent
applications, including eight allowed patent applications, on its NexACT(r)
technology, its acquired products, and on other products and technologies
throughout the world. Patents covering Vitaros(r), for erectile dysfunction, have
been issued in Australia, Canada, Eurasia, Europe, Hong Kong, Israel, Japan,
Mexico, New Zealand, Singapore, South Africa, South Korea, Turkey, Taiwan, and
the United States.
About Vitaros(r)
Vitaros(r) is a topically delivered formulation of alprostadil combined with the
Company's proprietary NexACT(r) delivery technology for the treatment of erectile
dysfunction (ED). The NexACT(r) delivery technology enhances the penetration ofalprostadil through the skin. When absorbed through the skin, alprostadil, a
vasodilator, directly boosts blood flow, thereby causing an erection.
Vitaros(r) differs from oral medications in two ways. First, it is applied
locally, directly to the penis as a cream, instead of administered orally and
absorbed systemically. This topical application helps to reduce side effects
and provides a patient-friendly alternative for men who cannot take the
existing oral medications. Second, clinical studies have shown that Vitaros(r)
works in approximately 15 minutes on average, compared to a reported onset time
of 30 minutes, or longer, for oral medications.
About DDAIP
DDAIP is a small molecule permeation enhancer used in Apricus Bio's NexACT(r)
drug delivery technology to enables rapid absorption of high concentrations of
an active pharmaceutical ingredient directly at the target site and to enhance
the delivery of an active drug to the patient. The NexACT(r) technology has been
used in multiple Apricus Bio products, including Vitaros(r), Femprox(r) and MycoVa(tm)
and administered to over 5,000 patients in clinical studies.
About Apricus Biosciences, Inc.
Apricus Bio is a San Diego-based revenue-generating pharmaceutical company,
with commercial products and a broad pipeline across numerous therapeutic
classes.
Revenues and growth are driven from the sales of the Company's commercial
products through its Apricus Pharmaceuticals USA, Inc. and NexMed (U.S.A.),
Inc. subsidiaries and through out-licensing in certain territories of its
product pipeline and NexACT(r) technology.
Apricus Bio's current NexACT(r) pipeline includes Vitaros(r), approved in Canada
for the treatment of erectile dysfunction, as well as compounds in development
from pre-clinical through pre-registration currently focused on Sexual
Dysfunction, Oncology, Dermatology, Autoimmune, Pain, Anti-Infectives, Diabetes
and Consumer Healthcare.
Apricus Bio currently markets Totect(r) (dexrazoxane HCl), the only drug approved
in the US for the treatment of anthracycline extravasation. The Company also
plans to market in the U.S. or certain other countries the following products:
(a) Granisol(r) (granisetron HCI) oral solution, the only FDA-approved, oral,
ready-to-use liquid solution of granisetron, (b) Aquoral(tm), an FDA-cleared,
prescription-only spray for the treatment of Xerostomia (the medical term for
dry mouth due to a lack of saliva) and (c) NitroMist(r) (nitroglycerin sublingual
spray), an FDA-approved nitrate vasodilator indicated for acute relief of an
attack or acute prophylaxis of angina pectoris (chest pain) due to coronary
artery disease (narrowing of the blood vessels that supply blood to the heart).
The Company also expects to develop and/or acquire and then bring to market
additional pharmaceutical products in areas of care that will benefit patient
needs worldwide.
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.
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 further develop its products and
product candidates, to have its products and product candidates such as
Vitaros(r) receive patent protection and be approved by relevant regulatory
authorities, to successfully commercialize such products as Vitaros(r) for
erectile dysfunction and NexACT(r) product candidates and drug delivery
technology and to achieve its 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 Bio Investor Relations:
David Pitts
Argot Partners
212-600-1902
david(at)argotpartners.com
News Source: NASDAQ OMX
25.05.2012 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 Announcement DGAP News-Service
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Datum: 25.05.2012 - 19:20 Uhr
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