Apricus Biosciences Receives Notice of Issuance for First Prevonco(TM) Patent in the United States
Apricus Biosciences, Inc.
26.04.2012 18:00
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SAN DIEGO, 2012-04-26 18:00 CEST (GLOBE NEWSWIRE) --
Apricus Biosciences, Inc. ('Apricus Bio' or the 'Company') (Nasdaq:APRI)
(http://www.apricusbio.com), announced today that the Company received an Issue
Notification from the United States Patent and Trademark Office for U.S. Patent
Application No. 12/138,603 entitled 'Thiazole Compounds, and Compositions and
Methods Using Same.' This soon-to-be issued patent claims certain compositions
and methods for inhibiting tumor growth related to PrevOnco(tm), Apricus Bio's
proprietary Phase III-ready cancer treatment for patients with advanced,
unresectable hepatocellular carcinoma ('HCC'), or liver cancer. When issued,
the patent will provide patent protection into 2029 and will be the Company's
first granted patent in the United States for PrevOnco(tm).
The Company currently has two other PrevOnco(tm) patent applications pending in
the United States. Worldwide, Apricus Bio has one granted patent for PrevOnco(tm)
in Canada and 10 pending applications in Canada, China, European Union, Japan,
Israel, Mexico, New Zealand, and South Korea. The Company is also developing
oral PrevOnco(tm) applications that utilize its proprietary NexACT(r) technology
platform to be used as the final product for the Phase III that is in
discussion with the U.S. Food and Drug Administration ('FDA').
PrevOnco(tm), which was granted Orphan Drug status by the FDA for HCC, is a novel
formulation of lansoprazole, a commonly marketed anti-ulcer compound. The
Company's next stage in the FDA approval process is to run a human PK
equivalency trial with the NexAct(r) formulation and bridge this formulation to
the Phase III currently in discussion with the FDA.
Dr. Bassam Damaj, President and Chief Executive Officer of Apricus Bio
commented, 'This patent represents an important step forward in our effort to
develop and commercialize PrevOnco(tm) for the treatment of HCC, as it provides a
runway to realize the full clinical and commercial potential of this novel
therapy. With strong intellectual property and exclusivity for PrevOnco(tm), our
ongoing partnering efforts should be easier and hopefully faster.'
About Hepatocellular Carcinoma (HCC)
Hepatocellular carcinoma (HCC) is the seventh most common cancer in the world,
with a high incidence in China and other Asian countries. Although uncommon in
the U.S., there are a reported 8,500 to 11,000 new cases diagnosed each year,
comprising 2% of all malignancies. Cases in the U.S. occur primarily in men of
Chinese descent, a subpopulation which has a high incidence of viral hepatitis
- a known risk factor for HCC.
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 (USA), 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,
such as PrevOnco(tm), and product candidates, to have its products and product
candidates receive patent protection and be approved by relevant regulatory
authorities, to successfully commercialize such products as Totect(r), Granisol(r),
Aquoral(tm) and NitroMist(tm) and 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.
CONTACT: Apricus Bio Investor Relations:David PittsArgot
Partners212-600-1902david@argotpartners.com
News Source: NASDAQ OMX
26.04.2012 Dissemination of a Corporate News, transmitted by DGAP -
a company of EquityStory AG.
The issuer is solely responsible for the content of this announcement.
DGAP's Distribution Services include Regulatory Announcements,
Financial/Corporate News and Press Releases.
Media archive at www.dgap-medientreff.de and www.dgap.de
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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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Apricus Biosciences, Inc.
26.04.2012 18:00
---------------------------------------------------------------------------
SAN DIEGO, 2012-04-26 18:00 CEST (GLOBE NEWSWIRE) --
Apricus Biosciences, Inc. ('Apricus Bio' or the 'Company') (Nasdaq:APRI)
(http://www.apricusbio.com), announced today that the Company received an Issue
Notification from the United States Patent and Trademark Office for U.S. Patent
Application No. 12/138,603 entitled 'Thiazole Compounds, and Compositions and
Methods Using Same.' This soon-to-be issued patent claims certain compositions
and methods for inhibiting tumor growth related to PrevOnco(tm), Apricus Bio's
proprietary Phase III-ready cancer treatment for patients with advanced,
unresectable hepatocellular carcinoma ('HCC'), or liver cancer. When issued,
the patent will provide patent protection into 2029 and will be the Company's
first granted patent in the United States for PrevOnco(tm).
The Company currently has two other PrevOnco(tm) patent applications pending in
the United States. Worldwide, Apricus Bio has one granted patent for PrevOnco(tm)
in Canada and 10 pending applications in Canada, China, European Union, Japan,
Israel, Mexico, New Zealand, and South Korea. The Company is also developing
oral PrevOnco(tm) applications that utilize its proprietary NexACT(r) technology
platform to be used as the final product for the Phase III that is in
discussion with the U.S. Food and Drug Administration ('FDA').
PrevOnco(tm), which was granted Orphan Drug status by the FDA for HCC, is a novel
formulation of lansoprazole, a commonly marketed anti-ulcer compound. The
Company's next stage in the FDA approval process is to run a human PK
equivalency trial with the NexAct(r) formulation and bridge this formulation to
the Phase III currently in discussion with the FDA.
Dr. Bassam Damaj, President and Chief Executive Officer of Apricus Bio
commented, 'This patent represents an important step forward in our effort to
develop and commercialize PrevOnco(tm) for the treatment of HCC, as it provides a
runway to realize the full clinical and commercial potential of this novel
therapy. With strong intellectual property and exclusivity for PrevOnco(tm), our
ongoing partnering efforts should be easier and hopefully faster.'
About Hepatocellular Carcinoma (HCC)
Hepatocellular carcinoma (HCC) is the seventh most common cancer in the world,
with a high incidence in China and other Asian countries. Although uncommon in
the U.S., there are a reported 8,500 to 11,000 new cases diagnosed each year,
comprising 2% of all malignancies. Cases in the U.S. occur primarily in men of
Chinese descent, a subpopulation which has a high incidence of viral hepatitis
- a known risk factor for HCC.
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 (USA), 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,
such as PrevOnco(tm), and product candidates, to have its products and product
candidates receive patent protection and be approved by relevant regulatory
authorities, to successfully commercialize such products as Totect(r), Granisol(r),
Aquoral(tm) and NitroMist(tm) and 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.
CONTACT: Apricus Bio Investor Relations:David PittsArgot
Partners212-600-1902david@argotpartners.com
News Source: NASDAQ OMX
26.04.2012 Dissemination of a Corporate News, transmitted by DGAP -
a company of EquityStory AG.
The issuer is solely responsible for the content of this announcement.
DGAP's Distribution Services include Regulatory Announcements,
Financial/Corporate News and Press Releases.
Media archive at www.dgap-medientreff.de and www.dgap.de
---------------------------------------------------------------------------
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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