Apricus Bioscience's Wholly-Owned Subsidiary NexMed (USA) Signs Exclusive German Collaboration for Vitaros(R) for Erectile Dysfunction
Apricus Biosciences, Inc.
16.02.2012 01:19
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SAN DIEGO, 2012-02-16 01:19 CET (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), Inc. has signed with Sandoz, a division of Novartis, an exclusive
collaboration for Germany to market Apricus Bio's Vitaros(r) drug for the
treatment of erectile dysfunction.
Pursuant to the collaboration, Sandoz will pay Apricus Bio up to [Eur]21 million -
divided into a fixed upfront payment and specific regulatory and commercial
milestones - as well as, double digit royalties on net sales. Total upfront and
milestone payments represent approximately $28 million based on today's
exchange rate.
Bassam Damaj, Chairman, President and Chief Executive Officer of Apricus Bio
commented, 'We are very excited about this major European collaboration with
such an important international pharmaceutical company as Sandoz. We are happy
to work again with Novartis through their division Sandoz and we look forward
to expanding the reach of our Vitaros(r) product for erectile dysfunction in
Germany. This is yet another important milestone in our strategy to make
Vitaros(r) available worldwide and the successful continuation of the execution
of our commercialization strategy of Vitaros(r).'
About Vitaros(r) and the ED Market in Europe
The ED market in Europe is presently dominated by oral PDE5 treatments.
However, there is still a need for new, safe and effective treatments,
especially for those patients who cannot or do not respond well to oral
medication. Vitaros(r) differs from oral PDE5 drugs like Viagra(r), Cialis(r) and
Levitra(r) in two ways. First, it is applied directly to the penis as a cream,
instead of as a pill that is absorbed systemically. The topical application
helps to reduce side effects and enables men who cannot take, or do not do well
with the existing drugs, to have a patient-friendly alternative.
Second, Vitaros(r) operates by a different biochemical mechanism than oral ED
medications, and causes erections to occur in a more localized fashion and more
quickly when compared to oral treatments. Vitaros(r) contains a previously known
compound, with the chemical name alprostadil. When absorbed through the skin,
alprostadil, a vasodilator, directly boosts blood flow, thereby causing an
erection. Clinical studies have shown that Vitaros(r) works on average in
approximately 15 minutes, compared to a reported onset time of 30 minutes or
more for oral medications indicated for the treatment of ED. The side effects
reported were localized and transient.
Alprostadil is currently marketed as an injectable drug. Apricus Bio
incorporated alprostadil with its NexACT(r) delivery technology, resulting in a
rapid and efficient topical delivery of the drug into the penis. In clinical
studies, Vitaros(r) worked in patients suffering from mild to severe ED,
including men who did not respond to Viagra(r). 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.; Vitaros(r) is a registered trademark in
Europe held by Apricus Bio through its subsidiary NexMed International Limited,
and in the U.S. held by Warner Chilcott Company.
About Apricus Biosciences, Inc.
Apricus Bio is a San Diego-based, revenue-generating, specialty 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 currently markets
Totect(r)(dexrazoxane HCl), the only drug approved in the US for the treatment of
anthracycline extravasation. Apricus Bio's current 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.
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 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 and product candidates, to have its products and product candidates
approved by relevant regulatory authorities, including Europe, to successfully
commercialize such NexACT(r) products as Vitaros(r) for erectile dysfunction and
product candidates and to achieve its development, commercialization and
financial goals with Sandoz in Germany and other countries. 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@argotpartners.com
News Source: NASDAQ OMX
16.02.2012 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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Apricus Biosciences, Inc.
16.02.2012 01:19
---------------------------------------------------------------------------
SAN DIEGO, 2012-02-16 01:19 CET (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), Inc. has signed with Sandoz, a division of Novartis, an exclusive
collaboration for Germany to market Apricus Bio's Vitaros(r) drug for the
treatment of erectile dysfunction.
Pursuant to the collaboration, Sandoz will pay Apricus Bio up to [Eur]21 million -
divided into a fixed upfront payment and specific regulatory and commercial
milestones - as well as, double digit royalties on net sales. Total upfront and
milestone payments represent approximately $28 million based on today's
exchange rate.
Bassam Damaj, Chairman, President and Chief Executive Officer of Apricus Bio
commented, 'We are very excited about this major European collaboration with
such an important international pharmaceutical company as Sandoz. We are happy
to work again with Novartis through their division Sandoz and we look forward
to expanding the reach of our Vitaros(r) product for erectile dysfunction in
Germany. This is yet another important milestone in our strategy to make
Vitaros(r) available worldwide and the successful continuation of the execution
of our commercialization strategy of Vitaros(r).'
About Vitaros(r) and the ED Market in Europe
The ED market in Europe is presently dominated by oral PDE5 treatments.
However, there is still a need for new, safe and effective treatments,
especially for those patients who cannot or do not respond well to oral
medication. Vitaros(r) differs from oral PDE5 drugs like Viagra(r), Cialis(r) and
Levitra(r) in two ways. First, it is applied directly to the penis as a cream,
instead of as a pill that is absorbed systemically. The topical application
helps to reduce side effects and enables men who cannot take, or do not do well
with the existing drugs, to have a patient-friendly alternative.
Second, Vitaros(r) operates by a different biochemical mechanism than oral ED
medications, and causes erections to occur in a more localized fashion and more
quickly when compared to oral treatments. Vitaros(r) contains a previously known
compound, with the chemical name alprostadil. When absorbed through the skin,
alprostadil, a vasodilator, directly boosts blood flow, thereby causing an
erection. Clinical studies have shown that Vitaros(r) works on average in
approximately 15 minutes, compared to a reported onset time of 30 minutes or
more for oral medications indicated for the treatment of ED. The side effects
reported were localized and transient.
Alprostadil is currently marketed as an injectable drug. Apricus Bio
incorporated alprostadil with its NexACT(r) delivery technology, resulting in a
rapid and efficient topical delivery of the drug into the penis. In clinical
studies, Vitaros(r) worked in patients suffering from mild to severe ED,
including men who did not respond to Viagra(r). 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.; Vitaros(r) is a registered trademark in
Europe held by Apricus Bio through its subsidiary NexMed International Limited,
and in the U.S. held by Warner Chilcott Company.
About Apricus Biosciences, Inc.
Apricus Bio is a San Diego-based, revenue-generating, specialty 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 currently markets
Totect(r)(dexrazoxane HCl), the only drug approved in the US for the treatment of
anthracycline extravasation. Apricus Bio's current 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.
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 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 and product candidates, to have its products and product candidates
approved by relevant regulatory authorities, including Europe, to successfully
commercialize such NexACT(r) products as Vitaros(r) for erectile dysfunction and
product candidates and to achieve its development, commercialization and
financial goals with Sandoz in Germany and other countries. 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@argotpartners.com
News Source: NASDAQ OMX
16.02.2012 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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