Apricus Biosciences Announces Shareholder Update With New Focus as a Commercially-Driven Specialty Pharmaceutical Company
Apricus Biosciences, Inc.
16.02.2012 16:06
---------------------------------------------------------------------------
Company CEO Sets Goal to Grow Revenues in 2012 and Long-Term
SAN DIEGO, 2012-02-16 16:06 CET (GLOBE NEWSWIRE) --
Apricus Biosciences, Inc. ('Apricus Bio' or the 'Company') (Nasdaq:APRI)
announced today a corporate update to address Company activities and expected
near-term events.
Dr. Bassam Damaj, Chairman, President and Chief Executive Officer of Apricus
Bio, stated, 'We believe that 2012 will be the most important in Apricus Bio's
history so far.' Dr. Damaj informed shareholders, 'The Company is now shifting
from a development stage company with little institutional ownership to a
commercial revenue-generating global operation with hopefully long-term
institutional investment support. The Company also expects to book
approximately $4 million from Vitaros(r) collaborations signed so far this year.
We believe that signing two major collaborations in the first quarter of this
year is a good indication that the Company plans to have major revenues from
Vitaros(r) collaborations and the beginning of product sales this year.'
The addition of a commercial oncology sales force with three marketed drugs to
sell in the U.S. is a major step for the Company in its efforts to start
generating its own direct sales. 'It's an important shift for the Company to
begin selling our drug products ourselves in some territories as it can drive
more revenue growth and places many of our commercialization timelines under
our own control,' Dr. Damaj stated. 'Oncology supportive care is our first step
in the U.S. with a sales force. Our goal is to expand into other focused
disease areas moving forward.'
'Apricus Bio's recently announced, institutionally-focused financing, now
provides our specialty pharmaceutical company with the institutional investment
support necessary to grow to the next level,' Dr. Damaj continued. 'Apricus Bio
looks forward to much broader investment coverage by an expanded range of
financial analysts in 2012.'
Apricus Bio is expanding the ownership of its stock from a predominantly retail
base to becoming more institutionally held. 'Such financing has provided our
Company with the important funding resources to directly grow Apricus Bio's
value by filing for commercialization authorization for up to five drug
products in 2012 and 2013; to launch newly acquired products; and to continue
to acquire additional, revenue-producing drug products,' he explained.
NexACT(r) Platform Products:
Vitaros(r)
Vitaros(r) (alprostadil), Apricus Bio's treatment for erectile dysfunction, is
now partnered in the U.S., Canada, Germany, certain countries in the Middle
East, the Gulf countries, Israel and Italy. Most recently, the Company entered
into (1) an exclusive licensing agreement with Abbott Laboratories Limited
('Abbott') to market Vitaros(r) in Canada, who plan to launch the product in
Canada in 2012 and (2) Sandoz, a division of Novartis, for Germany. The
Company's recent deal with Sandoz-Novartis is an important partnership to
Apricus not just for its large size but also for us being able to bring back
Novartis as a partner which brings back the confidence in our NexACT(r)
technology and the drugs based on it.
Apricus Bio's near term focus for Vitaros(r) is to commence sales in Canada this
year though its commercial partner Abbott, continue to generate revenue from
partnerships for the product with major pharma, including some which the
Company intends to enter into and announce in the near term.
The Company may also market the drug itself in certain territories in Europe as
the company expands its sales force and presence.
Femprox(r)
Femprox(r), a topical cream for the treatment of female sexual arousal disorder
('FSAD'), has been the subject of nine clinical studies completed to date,
including the only successfully completed Phase III and most advanced product
in development for the indication.
The Company expects to have guidance from the health agencies in the U.S.,
Europe and Canada by the end of Q2 2012.
Despite several setbacks in a similar space by third parties on other drugs in
this space recently, we are still the most advanced and the only Company that
ran a successful 400 patient Phase III clinical trial in FSAD and achieved
statistical significance on the primary and secondary endpoints. The Company
believes Femprox(r) is unique not only because of its direct and local mechanism
of action and safety profile, but also because of its relatively high response
rate in its successful Phase III clinical trial.
Apricus Bio also feels that this is a potential blockbuster product, which some
have estimated to be a $4 billion dollar space with no approved products on the
market yet.
MycoVa(tm)
MycoVa(tm), a topical treatment for onychomycosis (nail fungal infection) is the
Company's second partnered pipeline product utilizing Apricus Bio's proprietary
NexACT(r) technology. In December 2011 and January 2012, the Company completed
two licensing agreements granting exclusive marketing rights for MycoVa(tm) with
Stellar Pharmaceuticals, Inc. in Canada and Elis Pharmaceuticals in certain
countries in the Middle East and the Gulf Countries (excluding Israel).
The Company's regulatory strategy in the U.S. is to use its human blood and
nail bioequivalency study against Lamisil(r) cream in conjunctions with the
secondary endpoints from our 3 Phase III trials and file for approval using the
505b2 path. In Europe, the company intends to file for approval using the
non-inferiority analysis achieved against Loceryl(r) in our European phase III
trial. Lamisil(r) is a registered trademark of Novartis and Loceryl(r) is a
registered trademark of Galderma.
The Company expects to have guidance from the health agencies in the U.S.,
Europe and Canada by the end of Q2 2012.
Apricus Bio's Commercial Sales Force: Oncology Supportive Care Marketed
Products.
The Company launched its commercialization arm beginning in oncology supportive
care in December 2011 with the acquisition of Topotarget USA, Inc. (since
renamed Apricus Pharmaceuticals USA, Inc.) , gaining a pre-existing sales
infrastructure, sales team, and a revenue-generating product with what the
Company believes to be a strong future growth potential and additional second
use label. The oncology supportive care product platform was expanded through
an agreement with PediatRx, Inc. in January, with co-promotion rights to two
additional products in this space, Granisol(tm) and Aquoral(tm).
Totect(r)
Totect(r) (dexrazoxane HCl) is for the treatment of anthracycline extravasation,
the leakage of chemotherapies from the vein into the surrounding healthy
tissue. Totect(r) is the only proven protection against the potentially
devastating effects of anthracycline extravasation. The Company also intends to
grow the market potential for this product by filing a supplemental NDA this
year for a second use of cardiac protection for Doxorubicin use based on the
trials the Company has already run. The Company intends to further monetize
Totect(r) by partnering the product throughout Canada and Latin America. There
are presently 3,500 cancer centers in the U.S., all of which should eventually
carry Totect. There are approximately 550,000 anthracycline infusions each year
in the U.S. with estimates of extravasations calculated as high, occurring 1%
of the time, and potential uses for the second label if granted by the FDA.
Granisol(tm)
Granisol(tm) (granisetron) is the only FDA-approved, oral, ready-to-use liquid
solution of granisetron oral solution for prevention of nausea and vomiting
associated with emetogenic cancer therapy and radiation. In addition to U.S.
co-promotion rights, Apricus Bio purchased non-U.S rights to Granisol(tm). The
present oral solution market for the anti-emetics is approximately $70 million
in the U.S. with the overall oral market for anti-emetics above $3 billion.
Aquoral(tm)
Aquoral is an FDA-cleared, prescription-only spray for the treatment of
Xerostomia (the medical term for dry mouth due to a lack of saliva). Xerostomia
is caused by oncology, central nervous system drugs. The Company intends to
detail the drug for the oncology use through its sales force and partner the
CNS use.
The advantage of an oncology support sales force is that the same salesperson
can help sell multiple products to the same end user which in our case is the
oncology supportive care nurse and the hospital pharmacist who stocks the
product. Chemotherapy and radiation therapy may result in side effects and
often the same patients can experience extravasation (therefore requiring
Totect(r)), nausea (therefore requiring Granisol(tm)) and Xerostomia (therefore
requiring Aquoral(tm)) in addition to pain, mucositis, dermatitis in addition to
other potential side effects.
The Company additionally has announced in January of this year that it is in
negotiations to acquire PediatRx and it currently expects to have approximately
25 supportive care sales force in addition to an additional 100 on-call nurses
and a pharmacist call-center.
The Company is also currently in negotiations to acquire additional products
for this sales force
Other Specialty Pharmaceutical Transactions.
NitroMist(tm):
Apricus Bio further expanded its commercial arm worldwide with the acquisition
of ex-U.S. rights to NitroMist(tm), an FDA-approved and marketed 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). In February 2012, NovaDel Pharma
Inc. sold Apricus Bio the rights to sell and license NitroMist(tm) in territories
outside of the United States, Canada and Mexico. NovaDel has estimated the
worldwide market for NitroMist(tm) to be more than $200 million. The Company
intends to file for marketing authorization in Europe and certain other
countries in the acquired territory in 2012 and has already initiated
commercial partnering discussions.
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
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 such as Vitaros(r),
Femprox(r) and MycoVa(tm) and product candidates approved by relevant regulatory
authorities, to successfully commercialize such NexACT(r) products and product
candidates, to achieve its development, commercialization and financial goals
such as the booking of $4 million for Vitaros(r) partnerships to date and the
further commercialization of Totect(r), Granisol(tm) and Aquoral(tm) and to achieve its
other regulatory, commercial and financial goals in the U.S. and in 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.
CONTACT: Apricus Bio Investor Relations:David PittsArgot
Partners212-600-1902david@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
---------------------------------------------------------------------------
Apricus Biosciences, Inc.
16.02.2012 16:06
---------------------------------------------------------------------------
Company CEO Sets Goal to Grow Revenues in 2012 and Long-Term
SAN DIEGO, 2012-02-16 16:06 CET (GLOBE NEWSWIRE) --
Apricus Biosciences, Inc. ('Apricus Bio' or the 'Company') (Nasdaq:APRI)
announced today a corporate update to address Company activities and expected
near-term events.
Dr. Bassam Damaj, Chairman, President and Chief Executive Officer of Apricus
Bio, stated, 'We believe that 2012 will be the most important in Apricus Bio's
history so far.' Dr. Damaj informed shareholders, 'The Company is now shifting
from a development stage company with little institutional ownership to a
commercial revenue-generating global operation with hopefully long-term
institutional investment support. The Company also expects to book
approximately $4 million from Vitaros(r) collaborations signed so far this year.
We believe that signing two major collaborations in the first quarter of this
year is a good indication that the Company plans to have major revenues from
Vitaros(r) collaborations and the beginning of product sales this year.'
The addition of a commercial oncology sales force with three marketed drugs to
sell in the U.S. is a major step for the Company in its efforts to start
generating its own direct sales. 'It's an important shift for the Company to
begin selling our drug products ourselves in some territories as it can drive
more revenue growth and places many of our commercialization timelines under
our own control,' Dr. Damaj stated. 'Oncology supportive care is our first step
in the U.S. with a sales force. Our goal is to expand into other focused
disease areas moving forward.'
'Apricus Bio's recently announced, institutionally-focused financing, now
provides our specialty pharmaceutical company with the institutional investment
support necessary to grow to the next level,' Dr. Damaj continued. 'Apricus Bio
looks forward to much broader investment coverage by an expanded range of
financial analysts in 2012.'
Apricus Bio is expanding the ownership of its stock from a predominantly retail
base to becoming more institutionally held. 'Such financing has provided our
Company with the important funding resources to directly grow Apricus Bio's
value by filing for commercialization authorization for up to five drug
products in 2012 and 2013; to launch newly acquired products; and to continue
to acquire additional, revenue-producing drug products,' he explained.
NexACT(r) Platform Products:
Vitaros(r)
Vitaros(r) (alprostadil), Apricus Bio's treatment for erectile dysfunction, is
now partnered in the U.S., Canada, Germany, certain countries in the Middle
East, the Gulf countries, Israel and Italy. Most recently, the Company entered
into (1) an exclusive licensing agreement with Abbott Laboratories Limited
('Abbott') to market Vitaros(r) in Canada, who plan to launch the product in
Canada in 2012 and (2) Sandoz, a division of Novartis, for Germany. The
Company's recent deal with Sandoz-Novartis is an important partnership to
Apricus not just for its large size but also for us being able to bring back
Novartis as a partner which brings back the confidence in our NexACT(r)
technology and the drugs based on it.
Apricus Bio's near term focus for Vitaros(r) is to commence sales in Canada this
year though its commercial partner Abbott, continue to generate revenue from
partnerships for the product with major pharma, including some which the
Company intends to enter into and announce in the near term.
The Company may also market the drug itself in certain territories in Europe as
the company expands its sales force and presence.
Femprox(r)
Femprox(r), a topical cream for the treatment of female sexual arousal disorder
('FSAD'), has been the subject of nine clinical studies completed to date,
including the only successfully completed Phase III and most advanced product
in development for the indication.
The Company expects to have guidance from the health agencies in the U.S.,
Europe and Canada by the end of Q2 2012.
Despite several setbacks in a similar space by third parties on other drugs in
this space recently, we are still the most advanced and the only Company that
ran a successful 400 patient Phase III clinical trial in FSAD and achieved
statistical significance on the primary and secondary endpoints. The Company
believes Femprox(r) is unique not only because of its direct and local mechanism
of action and safety profile, but also because of its relatively high response
rate in its successful Phase III clinical trial.
Apricus Bio also feels that this is a potential blockbuster product, which some
have estimated to be a $4 billion dollar space with no approved products on the
market yet.
MycoVa(tm)
MycoVa(tm), a topical treatment for onychomycosis (nail fungal infection) is the
Company's second partnered pipeline product utilizing Apricus Bio's proprietary
NexACT(r) technology. In December 2011 and January 2012, the Company completed
two licensing agreements granting exclusive marketing rights for MycoVa(tm) with
Stellar Pharmaceuticals, Inc. in Canada and Elis Pharmaceuticals in certain
countries in the Middle East and the Gulf Countries (excluding Israel).
The Company's regulatory strategy in the U.S. is to use its human blood and
nail bioequivalency study against Lamisil(r) cream in conjunctions with the
secondary endpoints from our 3 Phase III trials and file for approval using the
505b2 path. In Europe, the company intends to file for approval using the
non-inferiority analysis achieved against Loceryl(r) in our European phase III
trial. Lamisil(r) is a registered trademark of Novartis and Loceryl(r) is a
registered trademark of Galderma.
The Company expects to have guidance from the health agencies in the U.S.,
Europe and Canada by the end of Q2 2012.
Apricus Bio's Commercial Sales Force: Oncology Supportive Care Marketed
Products.
The Company launched its commercialization arm beginning in oncology supportive
care in December 2011 with the acquisition of Topotarget USA, Inc. (since
renamed Apricus Pharmaceuticals USA, Inc.) , gaining a pre-existing sales
infrastructure, sales team, and a revenue-generating product with what the
Company believes to be a strong future growth potential and additional second
use label. The oncology supportive care product platform was expanded through
an agreement with PediatRx, Inc. in January, with co-promotion rights to two
additional products in this space, Granisol(tm) and Aquoral(tm).
Totect(r)
Totect(r) (dexrazoxane HCl) is for the treatment of anthracycline extravasation,
the leakage of chemotherapies from the vein into the surrounding healthy
tissue. Totect(r) is the only proven protection against the potentially
devastating effects of anthracycline extravasation. The Company also intends to
grow the market potential for this product by filing a supplemental NDA this
year for a second use of cardiac protection for Doxorubicin use based on the
trials the Company has already run. The Company intends to further monetize
Totect(r) by partnering the product throughout Canada and Latin America. There
are presently 3,500 cancer centers in the U.S., all of which should eventually
carry Totect. There are approximately 550,000 anthracycline infusions each year
in the U.S. with estimates of extravasations calculated as high, occurring 1%
of the time, and potential uses for the second label if granted by the FDA.
Granisol(tm)
Granisol(tm) (granisetron) is the only FDA-approved, oral, ready-to-use liquid
solution of granisetron oral solution for prevention of nausea and vomiting
associated with emetogenic cancer therapy and radiation. In addition to U.S.
co-promotion rights, Apricus Bio purchased non-U.S rights to Granisol(tm). The
present oral solution market for the anti-emetics is approximately $70 million
in the U.S. with the overall oral market for anti-emetics above $3 billion.
Aquoral(tm)
Aquoral is an FDA-cleared, prescription-only spray for the treatment of
Xerostomia (the medical term for dry mouth due to a lack of saliva). Xerostomia
is caused by oncology, central nervous system drugs. The Company intends to
detail the drug for the oncology use through its sales force and partner the
CNS use.
The advantage of an oncology support sales force is that the same salesperson
can help sell multiple products to the same end user which in our case is the
oncology supportive care nurse and the hospital pharmacist who stocks the
product. Chemotherapy and radiation therapy may result in side effects and
often the same patients can experience extravasation (therefore requiring
Totect(r)), nausea (therefore requiring Granisol(tm)) and Xerostomia (therefore
requiring Aquoral(tm)) in addition to pain, mucositis, dermatitis in addition to
other potential side effects.
The Company additionally has announced in January of this year that it is in
negotiations to acquire PediatRx and it currently expects to have approximately
25 supportive care sales force in addition to an additional 100 on-call nurses
and a pharmacist call-center.
The Company is also currently in negotiations to acquire additional products
for this sales force
Other Specialty Pharmaceutical Transactions.
NitroMist(tm):
Apricus Bio further expanded its commercial arm worldwide with the acquisition
of ex-U.S. rights to NitroMist(tm), an FDA-approved and marketed 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). In February 2012, NovaDel Pharma
Inc. sold Apricus Bio the rights to sell and license NitroMist(tm) in territories
outside of the United States, Canada and Mexico. NovaDel has estimated the
worldwide market for NitroMist(tm) to be more than $200 million. The Company
intends to file for marketing authorization in Europe and certain other
countries in the acquired territory in 2012 and has already initiated
commercial partnering discussions.
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
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 such as Vitaros(r),
Femprox(r) and MycoVa(tm) and product candidates approved by relevant regulatory
authorities, to successfully commercialize such NexACT(r) products and product
candidates, to achieve its development, commercialization and financial goals
such as the booking of $4 million for Vitaros(r) partnerships to date and the
further commercialization of Totect(r), Granisol(tm) and Aquoral(tm) and to achieve its
other regulatory, commercial and financial goals in the U.S. and in 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.
CONTACT: Apricus Bio Investor Relations:David PittsArgot
Partners212-600-1902david@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
---------------------------------------------------------------------------