Apricus Biosciences and Stellar Pharmaceuticals Announce Exclusive License Agreement in Canada for the Commercialization of MycoVa(TM) for Onychomycosis
Apricus Biosciences, Inc.
03.01.2012 15:00
---------------------------------------------------------------------------
Apricus Bio Can Receive Up to Approximately $8 Million (Canadian) Plus Tiered
Double Digit Royalties Under Multi-year Agreement
Stellar Pharma Strengthens Its Dermatology Business in Canada With Its Second
Prescription Product, MycoVa(tm)
SAN DIEGO and MILTON, Ontario, Jan. 3, 2012 (GLOBE NEWSWIRE) -- Apricus
Biosciences, Inc. ('Apricus Bio') (Nasdaq:APRI) (http://www.apricusbio.com) and
Stellar Pharmaceuticals Inc. ('Stellar Pharma') (OTCQB:SLXCF) (OTCBB:SLXCF)
(Pink Sheets:SLXCF), a Canadian public company, announced today the signing of
an exclusive license agreement. Under the agreement, Stellar Pharma has the
exclusive right to sell Apricus Bio's MycoVa(tm) product for the treatment of
onychomycosis (nail fungus) in Canada, following receipt of Canadian regulatory
approval for such product. The exclusive license agreement provides for an
upfront payment, regulatory approval milestone, sales achievement milestones
and royalty payments during the term of the agreement.
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.
Dr. Bassam Damaj, Chairman, President and Chief Executive Officer of Apricus
Bio commented, 'We are very pleased with our exclusive license agreement with
Stellar Pharma and we look forward to the future commercialization in the
Canadian market of MycoVa(tm), our second major product utilizing our proprietary
NexACT(r) technology. We are very impressed with the experience of Rob Harris and
his team at Stellar Pharma, and we are very excited about this first potential
launch of this important drug in that market. We also hope that our partnership
with Stellar Pharma will produce additional collaborations among multiple
NexACT(r) products in the future.'
Rob Harris, President and Chief Executive Officer of Stellar Pharma stated, 'We
are excited about this opportunity and are very pleased to be able to
strengthen our dermatology portfolio in Canada. I would like to thank Bassam
and his excellent team at Apricus Bio for providing us with this opportunity to
launch MycoVa(tm) in the Canadian market. We will be assisting Apricus Bio in the
filing of a New Drug Submission for MycoVa(tm) for onychomycosis and look forward
to its commercial launch in Canada following Canadian regulatory approval.'
About MycoVa(tm)
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 Stellar Pharmaceuticals Inc.
Stellar Pharma and its subsidiary, Tribute Pharmaceuticals, is an emerging
Canadian specialty pharmaceutical company focused on the acquisition,
licensing, development and management of pharmaceutical and healthcare products
with its primary focus on the Canadian market. Stellar Pharma currently
competes in the dermatology market in Canada with its promotion of Soriatane(r)*
(acitretin).
Stellar Pharma also markets Bezalip(r)* SR (bezafibrate), NeoVisc(r) (1.0% sodium
hyaluronate solution) and Uracyst(r) (sodium chondroitin sulfate solution 2%) in
the Canadian market place and is awaiting regulatory approval for Cambia(r)**
(diclofenac potassium for oral solution) in Canada. Additionally, NeoVisc(r) and
Uracyst(r) are commercially available in 58 countries and are sold globally
through various international partnerships. Stellar Pharma is currently in
negotiations to license both NeoVisc(r) and Uracyst(r) in the US and other
international markets.
For further information on Stellar Pharma, visit http://www.stellarpharma.com,
and for information on its subsidiary please visit
http://www.tributepharma.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, 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.
Stellar Pharmaceuticals' Forward Looking Statement
This press release contains certain forward-looking statements about Stellar
Pharma as defined in the Private Securities Litigation Reform Act of 1995,
which statements can be identified by the use of forward-looking terminology,
such as 'may', 'will', 'expect', 'intend', 'anticipate', 'estimate', 'predict',
'plan' or 'continue' or the negative thereof or other variations thereon or
comparable terminology referring to future events or results. Forward-looking
statements, by their nature, are subject to risks and uncertainties, Stellar
Pharma's actual results could differ materially from those anticipated in these
forward-looking statements as a result of numerous factors, including general
economic conditions, the ability of Stellar Pharma to successfully integrate
operations, and the timing of expenditures and expansion opportunities, any of
which could cause actual results to vary materially from current results or
anticipated future results. See Stellar Pharma's reports filed with the
Canadian Securities Regulatory Authorities and the U.S. Securities and Exchange
Commission from time to time for cautionary statements identifying important
factors with respect to such forward-looking statements, including certain
risks and uncertainties, that could cause actual results to differ materially
from results referred to in forward-looking statements. Stellar Pharma assumes
no obligation to update the information contained in this press release to
update forward-looking statements to reflect changed assumptions, the
occurrence of anticipated events or changes in future operating results,
financial condition or business over time.
*Soriatane and Bezalip are registered trademarks and under license from Actavis
Group PTC ehf
**Cambia is a registered trademark and under license from Nautilus
Neurosciences, Inc.
CONTACT: Apricus Biosciences, Inc.
Edward Cox, V.P.
Corporate Development & Investor Relations, 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
Stellar Pharmaceuticals Inc.
Attention: Scott Langille
CFO
(519) 434-1540
scott.langille@stellarpharma.com
Attention: Arnold Tenney
Chairman
705-445-9505
News Source: NASDAQ OMX
03.01.2012 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
---------------------------------------------------------------------------
Apricus Biosciences, Inc.
03.01.2012 15:00
---------------------------------------------------------------------------
Apricus Bio Can Receive Up to Approximately $8 Million (Canadian) Plus Tiered
Double Digit Royalties Under Multi-year Agreement
Stellar Pharma Strengthens Its Dermatology Business in Canada With Its Second
Prescription Product, MycoVa(tm)
SAN DIEGO and MILTON, Ontario, Jan. 3, 2012 (GLOBE NEWSWIRE) -- Apricus
Biosciences, Inc. ('Apricus Bio') (Nasdaq:APRI) (http://www.apricusbio.com) and
Stellar Pharmaceuticals Inc. ('Stellar Pharma') (OTCQB:SLXCF) (OTCBB:SLXCF)
(Pink Sheets:SLXCF), a Canadian public company, announced today the signing of
an exclusive license agreement. Under the agreement, Stellar Pharma has the
exclusive right to sell Apricus Bio's MycoVa(tm) product for the treatment of
onychomycosis (nail fungus) in Canada, following receipt of Canadian regulatory
approval for such product. The exclusive license agreement provides for an
upfront payment, regulatory approval milestone, sales achievement milestones
and royalty payments during the term of the agreement.
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.
Dr. Bassam Damaj, Chairman, President and Chief Executive Officer of Apricus
Bio commented, 'We are very pleased with our exclusive license agreement with
Stellar Pharma and we look forward to the future commercialization in the
Canadian market of MycoVa(tm), our second major product utilizing our proprietary
NexACT(r) technology. We are very impressed with the experience of Rob Harris and
his team at Stellar Pharma, and we are very excited about this first potential
launch of this important drug in that market. We also hope that our partnership
with Stellar Pharma will produce additional collaborations among multiple
NexACT(r) products in the future.'
Rob Harris, President and Chief Executive Officer of Stellar Pharma stated, 'We
are excited about this opportunity and are very pleased to be able to
strengthen our dermatology portfolio in Canada. I would like to thank Bassam
and his excellent team at Apricus Bio for providing us with this opportunity to
launch MycoVa(tm) in the Canadian market. We will be assisting Apricus Bio in the
filing of a New Drug Submission for MycoVa(tm) for onychomycosis and look forward
to its commercial launch in Canada following Canadian regulatory approval.'
About MycoVa(tm)
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 Stellar Pharmaceuticals Inc.
Stellar Pharma and its subsidiary, Tribute Pharmaceuticals, is an emerging
Canadian specialty pharmaceutical company focused on the acquisition,
licensing, development and management of pharmaceutical and healthcare products
with its primary focus on the Canadian market. Stellar Pharma currently
competes in the dermatology market in Canada with its promotion of Soriatane(r)*
(acitretin).
Stellar Pharma also markets Bezalip(r)* SR (bezafibrate), NeoVisc(r) (1.0% sodium
hyaluronate solution) and Uracyst(r) (sodium chondroitin sulfate solution 2%) in
the Canadian market place and is awaiting regulatory approval for Cambia(r)**
(diclofenac potassium for oral solution) in Canada. Additionally, NeoVisc(r) and
Uracyst(r) are commercially available in 58 countries and are sold globally
through various international partnerships. Stellar Pharma is currently in
negotiations to license both NeoVisc(r) and Uracyst(r) in the US and other
international markets.
For further information on Stellar Pharma, visit http://www.stellarpharma.com,
and for information on its subsidiary please visit
http://www.tributepharma.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, 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.
Stellar Pharmaceuticals' Forward Looking Statement
This press release contains certain forward-looking statements about Stellar
Pharma as defined in the Private Securities Litigation Reform Act of 1995,
which statements can be identified by the use of forward-looking terminology,
such as 'may', 'will', 'expect', 'intend', 'anticipate', 'estimate', 'predict',
'plan' or 'continue' or the negative thereof or other variations thereon or
comparable terminology referring to future events or results. Forward-looking
statements, by their nature, are subject to risks and uncertainties, Stellar
Pharma's actual results could differ materially from those anticipated in these
forward-looking statements as a result of numerous factors, including general
economic conditions, the ability of Stellar Pharma to successfully integrate
operations, and the timing of expenditures and expansion opportunities, any of
which could cause actual results to vary materially from current results or
anticipated future results. See Stellar Pharma's reports filed with the
Canadian Securities Regulatory Authorities and the U.S. Securities and Exchange
Commission from time to time for cautionary statements identifying important
factors with respect to such forward-looking statements, including certain
risks and uncertainties, that could cause actual results to differ materially
from results referred to in forward-looking statements. Stellar Pharma assumes
no obligation to update the information contained in this press release to
update forward-looking statements to reflect changed assumptions, the
occurrence of anticipated events or changes in future operating results,
financial condition or business over time.
*Soriatane and Bezalip are registered trademarks and under license from Actavis
Group PTC ehf
**Cambia is a registered trademark and under license from Nautilus
Neurosciences, Inc.
CONTACT: Apricus Biosciences, Inc.
Edward Cox, V.P.
Corporate Development & Investor Relations, 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
Stellar Pharmaceuticals Inc.
Attention: Scott Langille
CFO
(519) 434-1540
scott.langille@stellarpharma.com
Attention: Arnold Tenney
Chairman
705-445-9505
News Source: NASDAQ OMX
03.01.2012 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
---------------------------------------------------------------------------