Apricus Biosciences Announces Podium Presentation of Efficacy and Clinical Safety Data for Vitaros(R) at the European Sexual Society Medicine Conference
Apricus Biosciences, Inc.
30.11.2011 15:42
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SAN DIEGO, 2011-11-30 15:42 CET (GLOBE NEWSWIRE) --
Apricus Biosciences, Inc. ('Apricus Bio' or the 'Company') (Nasdaq:APRI)
announced today the selection of an oral podium presentation on Vitaros(r)
entitled, 'Efficacy and Safety of Topical Aprostadil Cream (Vitaros(r)) in
Hypertensive, Diabetic and Cardiac Patients with Male Erectile Dysfunction,' at
the European Society of Sexual Medicine ('ESSM') conference, taking place in
Milan, Italy on December 1-4, 2011.
Dr. Jacques Buvat will give an oral presentation on Thursday December 1, 2011,
during the Male Sexual Health Session (PS-01-008), scheduled to take place from
2:00 pm to 3:30 pm CET in the Blue Room 2.
Dr. Buvat is the President of Societe Francophone de Medecine Sexuelle ('SFMS')
and the Chief Editor of the Bulletin of the SFMS and was a former President of
the International Society for Sexual Medicine ('ISSM') and former Chief Editor
of Bulletins for the International Society for Sexual and Impotence Research.
He has written more than 300 scientific papers or chapters in books on sexual
dysfunction and related matters and is a member of the Company's Sexual
Dysfunction Clinical Advisory Board.
The oral presentation will discuss the overall combined dataset from two
pivotal Phase III clinical trials in 1,732 patients suffering from erectile
dysfunction ('ED') with special focus on integrated sub-analyses of these
trials in patients with hypertension, cardiovascular disease and diabetes.
Apricus Bio received marketing approval for Vitaros(r) as a first-line treatment
for ED from Health Canada in November 2010 for sales of the product in that
country. In April 2011, the Company filed a marketing application in the
European Union, under the Decentralized Procedure ('DCP'), for Vitaros(r) for the
treatment of ED, with the Netherlands as its Reference Member State. Under the
DCP, approval in a Reference Member State means that a drug may be sold in all
of the European Union countries that were filed with the DCP as Concerned
Member States. In July 2011, Apricus Bio filed for regulatory approval with
Swissmedic, the Swiss Agency for Therapeutic Products for marketing of Vitaros(r)
in that country. Preparations for filing in certain Latin American countries
are ongoing.
About Vitaros(r) and the ED Market
The current leading drugs for erectile dysfunction are Viagra(r), Cialis(r) and
Levitra(r), which are taken in pill form and work by inhibiting an enzyme called
PDE5.
There is still a need for new, safe and effective treatments, however,
especially for those patients who cannot or do not respond well to oral
medication. Vitaros(r) differs from Viagra(r), Cialis(r) and Levitra(r) in two ways.
Instead of a pill, Vitaros(r) is applied directly to the penis as a cream. The
topical application helps to reduce side effects and offers men who do not do
well with the existing drugs a patient-friendly alternative.
Second, Vitaros(r) operates by a different biochemical mechanism than oral ED
medications. It contains a previously marketed ED drug known by the chemical
name of alprostadil. When absorbed through the skin, alprostadil directly
boosts blood flow, thereby causing an erection within minutes, which the
Company believes is much faster than the results from the currently marketed
oral treatments.
Alprostadil is currently marketed as an injectable drug or as a suppository
inserted into the urethra. The key innovation behind Vitaros(r) is combining
alprostadil with Apricus Bio's NexACT(r) delivery technology, which allows the
drug to pass through the skin and makes the treatment much easier to apply.
Viagra(r) is a registered trademark of Pfizer, Inc.; Cialis(r) is a registered
trademark of Lilly, USA; Levitra(r), is a registered trademark of Bayer A.G.; and
Vitaros(r) is a registered trademark in Canada held by Apricus Bio, and in the
U.S. held by Warner Chilcott Company.
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 Rx Division product pipeline, including its first
product, Vitaros(r), approved in Canada for the treatment of erectile
dysfunction, 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
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 ability to further develop its and their
products such as Vitaros(r) for erectile dysfunction and other products and
product candidates, to have its products and product candidates approved by
relevant regulatory authorities, to successfully commercialize such products
and product candidates 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 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
30.11.2011 Dissemination of a Corporate News, transmitted by DGAP -
a company of EquityStory AG.
The issuer is solely responsible for the content of this announcement.
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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Apricus Biosciences, Inc.
30.11.2011 15:42
---------------------------------------------------------------------------
SAN DIEGO, 2011-11-30 15:42 CET (GLOBE NEWSWIRE) --
Apricus Biosciences, Inc. ('Apricus Bio' or the 'Company') (Nasdaq:APRI)
announced today the selection of an oral podium presentation on Vitaros(r)
entitled, 'Efficacy and Safety of Topical Aprostadil Cream (Vitaros(r)) in
Hypertensive, Diabetic and Cardiac Patients with Male Erectile Dysfunction,' at
the European Society of Sexual Medicine ('ESSM') conference, taking place in
Milan, Italy on December 1-4, 2011.
Dr. Jacques Buvat will give an oral presentation on Thursday December 1, 2011,
during the Male Sexual Health Session (PS-01-008), scheduled to take place from
2:00 pm to 3:30 pm CET in the Blue Room 2.
Dr. Buvat is the President of Societe Francophone de Medecine Sexuelle ('SFMS')
and the Chief Editor of the Bulletin of the SFMS and was a former President of
the International Society for Sexual Medicine ('ISSM') and former Chief Editor
of Bulletins for the International Society for Sexual and Impotence Research.
He has written more than 300 scientific papers or chapters in books on sexual
dysfunction and related matters and is a member of the Company's Sexual
Dysfunction Clinical Advisory Board.
The oral presentation will discuss the overall combined dataset from two
pivotal Phase III clinical trials in 1,732 patients suffering from erectile
dysfunction ('ED') with special focus on integrated sub-analyses of these
trials in patients with hypertension, cardiovascular disease and diabetes.
Apricus Bio received marketing approval for Vitaros(r) as a first-line treatment
for ED from Health Canada in November 2010 for sales of the product in that
country. In April 2011, the Company filed a marketing application in the
European Union, under the Decentralized Procedure ('DCP'), for Vitaros(r) for the
treatment of ED, with the Netherlands as its Reference Member State. Under the
DCP, approval in a Reference Member State means that a drug may be sold in all
of the European Union countries that were filed with the DCP as Concerned
Member States. In July 2011, Apricus Bio filed for regulatory approval with
Swissmedic, the Swiss Agency for Therapeutic Products for marketing of Vitaros(r)
in that country. Preparations for filing in certain Latin American countries
are ongoing.
About Vitaros(r) and the ED Market
The current leading drugs for erectile dysfunction are Viagra(r), Cialis(r) and
Levitra(r), which are taken in pill form and work by inhibiting an enzyme called
PDE5.
There is still a need for new, safe and effective treatments, however,
especially for those patients who cannot or do not respond well to oral
medication. Vitaros(r) differs from Viagra(r), Cialis(r) and Levitra(r) in two ways.
Instead of a pill, Vitaros(r) is applied directly to the penis as a cream. The
topical application helps to reduce side effects and offers men who do not do
well with the existing drugs a patient-friendly alternative.
Second, Vitaros(r) operates by a different biochemical mechanism than oral ED
medications. It contains a previously marketed ED drug known by the chemical
name of alprostadil. When absorbed through the skin, alprostadil directly
boosts blood flow, thereby causing an erection within minutes, which the
Company believes is much faster than the results from the currently marketed
oral treatments.
Alprostadil is currently marketed as an injectable drug or as a suppository
inserted into the urethra. The key innovation behind Vitaros(r) is combining
alprostadil with Apricus Bio's NexACT(r) delivery technology, which allows the
drug to pass through the skin and makes the treatment much easier to apply.
Viagra(r) is a registered trademark of Pfizer, Inc.; Cialis(r) is a registered
trademark of Lilly, USA; Levitra(r), is a registered trademark of Bayer A.G.; and
Vitaros(r) is a registered trademark in Canada held by Apricus Bio, and in the
U.S. held by Warner Chilcott Company.
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 Rx Division product pipeline, including its first
product, Vitaros(r), approved in Canada for the treatment of erectile
dysfunction, 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
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 ability to further develop its and their
products such as Vitaros(r) for erectile dysfunction and other products and
product candidates, to have its products and product candidates approved by
relevant regulatory authorities, to successfully commercialize such products
and product candidates 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 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
30.11.2011 Dissemination of a Corporate News, transmitted by DGAP -
a company of EquityStory AG.
The issuer is solely responsible for the content of this announcement.
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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