Apricus Biosciences and Elis Pharma Sign License Agreement for MycoVa(TM) in the Middle East and the Gulf
Apricus Biosciences, Inc.
10.01.2012 15:51
---------------------------------------------------------------------------
Apricus Bio to Receive up to $2.1 Million, Plus Royalties
SAN DIEGO and DUBAI, United Arab Emirates, 2012-01-10 15:51 CET (GLOBE
NEWSWIRE) --
Apricus Biosciences, Inc. ('Apricus Bio') (www.apricusbio.com) (Nasdaq:APRI)
and Elis Pharmaceuticals ('Elis') (www.elispharmaceuticals.com), announced
today that the two companies have entered into a licensing agreement granting
Elis the exclusive rights to market MycoVa(tm), Apricus Bio's drug for
onychomycosis (nail fungal infection), in the Middle East and the Gulf
Countries, excluding Israel. The license agreement with Elis follows the recent
announcement by the Company of a similar license agreement granting Stellar
Pharmaceuticals, Inc. the exclusive right to market MycoVa(tm) in Canada
(http://www.apricusbio.com/press_01032012.html).
Under the terms of the agreement, Elis has exclusive rights in part of the
Middle East, including Saudi Arabia, Kuwait, Lebanon, Syria, Jordan, Iraq and
Yemen, and in the Gulf Countries (United Arab Emirates, Oman, Bahrain, Qatar),
excluding Israel, to commercialize and market MycoVa (tm). Apricus Bio is entitled
to receive up to $2.1 million in payments for signing, regulatory and sales
milestones. Further, Apricus Bio will receive tiered double digit royalties
based on Elis' sales of the product.
'We believe that MycoVa(tm) is following Vitaros(r) in its development,
commercialization and marketing phase. We are very happy to have entered into
our second licensing agreement for MycoVa(tm) as we execute on our announced
partnering plan for this product,' said Dr. Bassam Damaj, Chairman, President
and Chief Executive Officer of Apricus Bio. 'This is an important milestone for
us as we have moved a second product in our pipeline to the partnered phase.
We are looking forward to working further with Elis on launching MycoVa(tm) in the
Middle East and the Gulf Countries.'
Rashed Assouma, Chief Executive Officer of Elis, commented, 'In addition to our
agreement relating to Vitaros(r) for the treatment of erectile dysfunction, we
are excited to enter into a second license agreement with Apricus Bio for
MycoVa(tm) for the treatment of onychomycosis. This additional collaboration with
Apricus Bio will permit us to utilize our sales and marketing expertise in the
Middle East to bring these two products to the market once we have received the
applicable regulatory approval for each product.'
About Onychomycosis and MycoVa(tm)
Onychomycosis is a chronic persistent fungal infection of the nail bed
resulting in thickening and discoloration of the nail, which sometimes can be
accompanied by serious pain and disability. According to the Merck Manual, the
worldwide incidence rate of onychomycosis is approximately 10%. As described by
Iorizzo and Piraccini (2007), the incidence has been increasing due to
diabetes, immunosuppression and an aging population. While occurring in
approximately 2.6% of children younger than 18 years, it occurs in as much as
90% of the elderly population (eMedicine.medscape.com). As of 2008, Thomson
Reuters Pharma had stated that the worldwide market was approximately $2.8
billion in size and is expected to grow to approximately $2.9 billion by 2014.
The advantage of Apricus Bio's MycoVa(tm) product is that it is easy to apply, and
is therefore believed to improve patient compliance. MycoVa(tm) is applied to the
infected nails, typically at bedtime, with minimal preparation, such as simply
washing with soap and water. The formulation allows significant amounts of the
drug to penetrate through the nail plate to the nail bed and surrounding area
where fungus is located without significant systemic exposure.
MycoVa(tm) combines an existing, approved drug for nail fungus, terbinafine, with
the NexACT(r) technology that enhances the absorption of the drug through the
skin. In January 2011, the Company announced that an additional analysis showed
that MycoVa(tm) is as effective for the treatment of nail fungus as the current
European standard of care for topical therapy, Loceryl(r) (an ointment made by
Galderma).
In June 2011, the Company announced that based on a reanalysis of its Phase III
trials for its MycoVa(tm) product for treating onychomycosis (nail fungus), it is
revisiting its regulatory strategy for the drug and will seek guidance from
regulatory authorities in the U.S., Canada and Europe. A combined post-hoc
analysis of two randomized, double-blind, vehicle controlled, multicenter,
parallel group Phase III studies to assess the efficacy, safety and
tolerability of MycoVa(tm) demonstrated statistically significant results in
primary and secondary efficacy endpoints in favor of active treatment in
patients who did not present with comorbid tinea pedis (athlete's foot), as
these patients are considered at higher risk of reinfection.
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's current pipeline includes
Vitaros(r), approved in Canada for the treatment of erectile dysfunction, Totect(r)
the only drug approved in the US for the treatment of anthracycline
extravasation, 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.
About Elis Pharmaceuticals Limited
Established in the UAE, Elis Pharmaceuticals is one of the region's leading
companies dedicated to developing, manufacturing and marketing prescription and
generic, pharmaceuticals. The Company markets and distributes products in three
main categories: prescription medications, OTC and generics. With over 1000
pharmaceutical products in its portfolio, Elis Pharma is uniquely poised to
maximize the market potential of emerging products and is the likely choice for
commercializing and marketing any new pharmaceutical products in its territory.
The company serves drug wholesalers, distributors of pharmaceuticals,
ministries and departments of health; public, private, industry and military
hospitals, clinics and healthcare systems and affiliated organizations
worldwide. For further information on Elis Pharma and its subsidiaries, visit
http://www.elispharmaceuticals.com.
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 receive issued patents on its
NexACT(r) technology and products, develop such patented technology into product
candidates, have its Rx Division products and product candidates such as
Vitaros(r) and MycoVa(tm) approved by relevant regulatory authorities and its
Consumer Healthcare Division products either approved or cleared by relevant
regulatory authorities or be in compliance with appropriate regulatory
requirements, to successfully manufacture and commercialize such Rx Division
products as Totect(r) for the treatment of anthracycline extravasation, Vitaros(r)
for erectile dysfunction and MycoVa(tm) for onychomycosis in the U.S., Canada, the
Gulf countries and in parts of the Middle East and in other countries along
with its Consumer Healthcare Division products and product candidates and to
achieve its other 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 Contacts:
Ed Cox, V.P. Investor Relations &
Corporate Development
Apricus Biosciences
(858) 848-4249
ecox@apricusbio.com
Apricus Bio Investor Relations:
Paula Schwartz
Investor Relations
Rx Communications Group, LLC
(917) 322-2216
pschwartz@rxir.com
Elis Pharmaceuticals Contact:
Abdul-Khaleq Osman
Public Relations
Elis Pharmaceuticals
Tel +9714 2653 844
Pr@elispharmaceuticals.com
News Source: NASDAQ OMX
10.01.2012 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.
10.01.2012 15:51
---------------------------------------------------------------------------
Apricus Bio to Receive up to $2.1 Million, Plus Royalties
SAN DIEGO and DUBAI, United Arab Emirates, 2012-01-10 15:51 CET (GLOBE
NEWSWIRE) --
Apricus Biosciences, Inc. ('Apricus Bio') (www.apricusbio.com) (Nasdaq:APRI)
and Elis Pharmaceuticals ('Elis') (www.elispharmaceuticals.com), announced
today that the two companies have entered into a licensing agreement granting
Elis the exclusive rights to market MycoVa(tm), Apricus Bio's drug for
onychomycosis (nail fungal infection), in the Middle East and the Gulf
Countries, excluding Israel. The license agreement with Elis follows the recent
announcement by the Company of a similar license agreement granting Stellar
Pharmaceuticals, Inc. the exclusive right to market MycoVa(tm) in Canada
(http://www.apricusbio.com/press_01032012.html).
Under the terms of the agreement, Elis has exclusive rights in part of the
Middle East, including Saudi Arabia, Kuwait, Lebanon, Syria, Jordan, Iraq and
Yemen, and in the Gulf Countries (United Arab Emirates, Oman, Bahrain, Qatar),
excluding Israel, to commercialize and market MycoVa (tm). Apricus Bio is entitled
to receive up to $2.1 million in payments for signing, regulatory and sales
milestones. Further, Apricus Bio will receive tiered double digit royalties
based on Elis' sales of the product.
'We believe that MycoVa(tm) is following Vitaros(r) in its development,
commercialization and marketing phase. We are very happy to have entered into
our second licensing agreement for MycoVa(tm) as we execute on our announced
partnering plan for this product,' said Dr. Bassam Damaj, Chairman, President
and Chief Executive Officer of Apricus Bio. 'This is an important milestone for
us as we have moved a second product in our pipeline to the partnered phase.
We are looking forward to working further with Elis on launching MycoVa(tm) in the
Middle East and the Gulf Countries.'
Rashed Assouma, Chief Executive Officer of Elis, commented, 'In addition to our
agreement relating to Vitaros(r) for the treatment of erectile dysfunction, we
are excited to enter into a second license agreement with Apricus Bio for
MycoVa(tm) for the treatment of onychomycosis. This additional collaboration with
Apricus Bio will permit us to utilize our sales and marketing expertise in the
Middle East to bring these two products to the market once we have received the
applicable regulatory approval for each product.'
About Onychomycosis and MycoVa(tm)
Onychomycosis is a chronic persistent fungal infection of the nail bed
resulting in thickening and discoloration of the nail, which sometimes can be
accompanied by serious pain and disability. According to the Merck Manual, the
worldwide incidence rate of onychomycosis is approximately 10%. As described by
Iorizzo and Piraccini (2007), the incidence has been increasing due to
diabetes, immunosuppression and an aging population. While occurring in
approximately 2.6% of children younger than 18 years, it occurs in as much as
90% of the elderly population (eMedicine.medscape.com). As of 2008, Thomson
Reuters Pharma had stated that the worldwide market was approximately $2.8
billion in size and is expected to grow to approximately $2.9 billion by 2014.
The advantage of Apricus Bio's MycoVa(tm) product is that it is easy to apply, and
is therefore believed to improve patient compliance. MycoVa(tm) is applied to the
infected nails, typically at bedtime, with minimal preparation, such as simply
washing with soap and water. The formulation allows significant amounts of the
drug to penetrate through the nail plate to the nail bed and surrounding area
where fungus is located without significant systemic exposure.
MycoVa(tm) combines an existing, approved drug for nail fungus, terbinafine, with
the NexACT(r) technology that enhances the absorption of the drug through the
skin. In January 2011, the Company announced that an additional analysis showed
that MycoVa(tm) is as effective for the treatment of nail fungus as the current
European standard of care for topical therapy, Loceryl(r) (an ointment made by
Galderma).
In June 2011, the Company announced that based on a reanalysis of its Phase III
trials for its MycoVa(tm) product for treating onychomycosis (nail fungus), it is
revisiting its regulatory strategy for the drug and will seek guidance from
regulatory authorities in the U.S., Canada and Europe. A combined post-hoc
analysis of two randomized, double-blind, vehicle controlled, multicenter,
parallel group Phase III studies to assess the efficacy, safety and
tolerability of MycoVa(tm) demonstrated statistically significant results in
primary and secondary efficacy endpoints in favor of active treatment in
patients who did not present with comorbid tinea pedis (athlete's foot), as
these patients are considered at higher risk of reinfection.
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's current pipeline includes
Vitaros(r), approved in Canada for the treatment of erectile dysfunction, Totect(r)
the only drug approved in the US for the treatment of anthracycline
extravasation, 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.
About Elis Pharmaceuticals Limited
Established in the UAE, Elis Pharmaceuticals is one of the region's leading
companies dedicated to developing, manufacturing and marketing prescription and
generic, pharmaceuticals. The Company markets and distributes products in three
main categories: prescription medications, OTC and generics. With over 1000
pharmaceutical products in its portfolio, Elis Pharma is uniquely poised to
maximize the market potential of emerging products and is the likely choice for
commercializing and marketing any new pharmaceutical products in its territory.
The company serves drug wholesalers, distributors of pharmaceuticals,
ministries and departments of health; public, private, industry and military
hospitals, clinics and healthcare systems and affiliated organizations
worldwide. For further information on Elis Pharma and its subsidiaries, visit
http://www.elispharmaceuticals.com.
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 receive issued patents on its
NexACT(r) technology and products, develop such patented technology into product
candidates, have its Rx Division products and product candidates such as
Vitaros(r) and MycoVa(tm) approved by relevant regulatory authorities and its
Consumer Healthcare Division products either approved or cleared by relevant
regulatory authorities or be in compliance with appropriate regulatory
requirements, to successfully manufacture and commercialize such Rx Division
products as Totect(r) for the treatment of anthracycline extravasation, Vitaros(r)
for erectile dysfunction and MycoVa(tm) for onychomycosis in the U.S., Canada, the
Gulf countries and in parts of the Middle East and in other countries along
with its Consumer Healthcare Division products and product candidates and to
achieve its other 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 Contacts:
Ed Cox, V.P. Investor Relations &
Corporate Development
Apricus Biosciences
(858) 848-4249
ecox@apricusbio.com
Apricus Bio Investor Relations:
Paula Schwartz
Investor Relations
Rx Communications Group, LLC
(917) 322-2216
pschwartz@rxir.com
Elis Pharmaceuticals Contact:
Abdul-Khaleq Osman
Public Relations
Elis Pharmaceuticals
Tel +9714 2653 844
Pr@elispharmaceuticals.com
News Source: NASDAQ OMX
10.01.2012 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
---------------------------------------------------------------------------