Health Canada Grants Apricus Biosciences Pre-NDS Meeting for MycoVa(TM) for the Treatment of Onychomycosis
Apricus Biosciences, Inc.
11.05.2012 15:55
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SAN DIEGO, 2012-05-11 15:55 CEST (GLOBE NEWSWIRE) --
Apricus Biosciences, Inc. ('Apricus Bio' or the 'Company') (Nasdaq:APRI)
(http://www.apricusbio.com) announced today that Health Canada has granted the
Company's request for a Pre-New Drug Submission ('Pre-NDS') meeting to obtain
regulatory guidance from the agency for MycoVa(tm), the Company's topical
treatment for onychomycosis, or nail fungus. The meeting is scheduled to take
place July 18, 2012. Apricus Bio expects to obtain feedback from Health Canada
regarding the suitability of its Phase 3 development program to support a New
Drug Submission ('NDS') in Canada. In addition, the Company is seeking guidance
from the US Food and Drug Administration and will be filing for guidance from
the European Health Agency.
MycoVa(tm) is a topically applied formulation of terbinafine hydrochloride, a
well-known medication for nail fungus, delivered with Dodecyl dodecyl 2-(N, N
dimethylamino)-propionate hydrochloride ('DDAIP.HCl'), Apricus Bio's
proprietary NexACT(r) delivery technology, which enhances absorption of drugs
through the skin and other barriers including the nail plate and nail bed. The
Company believes MycoVa(tm) clinical trials have exhibited a significant
mycological effect to eradicate the fungus and also has successfully
demonstrated non-inferiority compared to Loceryl(r), the current topical standard
of care for onychomycosis in Europe. In addition, Apricus Bio believes the
safety profile of topical terbinafine is significantly improved and much better
tolerated than oral terbinafine, which is limited in use to some patients due
to its potential for liver toxicity.
'We are convinced MycoVa(tm) has the potential to be an effective treatment option
for patients with mild to moderate onychomycosis,' said Bassam Damaj, PhD,
President and Chief Executive Officer of Apricus Bio. 'We expect this upcoming
meeting to provide valuable regulatory guidance from Health Canada and will
enable us to determine the next steps toward our goal of approval and
commercialization of MycoVa(tm) in the Canadian market.'
Apricus Bio is currently partnered with Stellar Pharmaceuticals Inc. for the
commercialization and marketing of MycoVa(tm) in Canada following receipt of
regulatory approval by Health Canada.
More About MycoVa(tm)
In a 2009 Phase III clinical comparator study, MycoVa(tm) was determined to be no
less effective than Loceryl(r) in curing nail fungus. In this study, 1,029
patients with mild to moderate nail fungus were given either MycoVa(tm) (topical
10% terbinafine hydrogen chloride formulation) or Loceryl(r) (5% amorolfine nail
laquer) for 48 weeks. The primary endpoint was a complete cure, and the
secondary endpoints were killing the fungus and improving the appearance of the
nail. A formal reanalysis of initial study results showed no significant
difference in either primary or secondary endpoints between MycoVa(tm) and
Loceryl(r). Loceryl(r) is a registered trademark of Galderma.
MycoVa(tm) was also the subject of two Phase 3, randomized, double-blind, vehicle
controlled, multicenter, parallel group studies to assess the efficacy, safety,
and tolerability of MycoVa(tm). A combined, post-hoc analysis of these two Phase
III clinical studies, completed by Apricus Bio in 2011, demonstrated
statistically significant results in mycological cure, resulting in the
eradication of nail fungus in favor of MycoVa(tm) treatment in patients that did
not present with comorbid tinea pedis (athlete's foot).
In the Company's view, MycoVa(tm) has distinct advantages over Loceryl(r) for nail
fungus suffers. MycoVa(tm) is simple and easy to apply, which could greatly
improve patient compliance. The product is applied directly to the infected
nails, typically at bedtime, accompanies by a simple washing with soap and
water. The formulation allows significant amounts of the active ingredient to
penetrate through the nail plate to the nail bed and surrounding area where
fungus is located without significant systemic exposure. By contrast, Loceryl(r)
requires more patient care before applying the lacquer, including filing the
affected areas of nail, including the nail surfaces, as thoroughly as possible.
The surface of the nail should then be cleansed using disposable swabs. The
nail lacquer is then applied onto the entire surface of the infected nail(s)
using reusable applicators. Before repeat application of Loceryl(r), the affected
nails should be filed down again and wiped with a cleansing pad to remove any
residual lacquer.
About Onychomycosis
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.
About Apricus Biosciences, Inc.
Apricus Bio is a San Diego-based revenue-generating 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 NexACT(r) 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.
Apricus Bio currently markets Totect(r) (dexrazoxane HCl), the only drug approved
in the US for the treatment of anthracycline extravasation. The Company also
plans to market in the U.S. or certain other countries the following products:
(a) Granisol(r) (granisetron HCI) oral solution, the only FDA-approved, oral,
ready-to-use liquid solution of granisetron, (b) Aquoral(tm), an FDA-cleared,
prescription-only spray for the treatment of Xerostomia (the medical term for
dry mouth due to a lack of saliva) and (c) NitroMist(tm) (nitroglycerin sublingual
spray), an FDA-approved 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).
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 products and
product candidates, to have its products and product candidates such as
Femprox(r) and MycoVa(tm) receive patent protection and be approved by relevant
regulatory authorities, to successfully commercialize such products as Totect(r)
, Granisol(r) , Aquoral(tm) and NitroMist(tm) and Vitaros(r) for erectile dysfunction and
NexACT(r) product candidates and drug delivery technology 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.
CONTACT: Apricus Bio Investor Relations:
David Pitts
Argot Partners
212-600-1902
david@argotpartners.com
News Source: NASDAQ OMX
11.05.2012 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.
11.05.2012 15:55
---------------------------------------------------------------------------
SAN DIEGO, 2012-05-11 15:55 CEST (GLOBE NEWSWIRE) --
Apricus Biosciences, Inc. ('Apricus Bio' or the 'Company') (Nasdaq:APRI)
(http://www.apricusbio.com) announced today that Health Canada has granted the
Company's request for a Pre-New Drug Submission ('Pre-NDS') meeting to obtain
regulatory guidance from the agency for MycoVa(tm), the Company's topical
treatment for onychomycosis, or nail fungus. The meeting is scheduled to take
place July 18, 2012. Apricus Bio expects to obtain feedback from Health Canada
regarding the suitability of its Phase 3 development program to support a New
Drug Submission ('NDS') in Canada. In addition, the Company is seeking guidance
from the US Food and Drug Administration and will be filing for guidance from
the European Health Agency.
MycoVa(tm) is a topically applied formulation of terbinafine hydrochloride, a
well-known medication for nail fungus, delivered with Dodecyl dodecyl 2-(N, N
dimethylamino)-propionate hydrochloride ('DDAIP.HCl'), Apricus Bio's
proprietary NexACT(r) delivery technology, which enhances absorption of drugs
through the skin and other barriers including the nail plate and nail bed. The
Company believes MycoVa(tm) clinical trials have exhibited a significant
mycological effect to eradicate the fungus and also has successfully
demonstrated non-inferiority compared to Loceryl(r), the current topical standard
of care for onychomycosis in Europe. In addition, Apricus Bio believes the
safety profile of topical terbinafine is significantly improved and much better
tolerated than oral terbinafine, which is limited in use to some patients due
to its potential for liver toxicity.
'We are convinced MycoVa(tm) has the potential to be an effective treatment option
for patients with mild to moderate onychomycosis,' said Bassam Damaj, PhD,
President and Chief Executive Officer of Apricus Bio. 'We expect this upcoming
meeting to provide valuable regulatory guidance from Health Canada and will
enable us to determine the next steps toward our goal of approval and
commercialization of MycoVa(tm) in the Canadian market.'
Apricus Bio is currently partnered with Stellar Pharmaceuticals Inc. for the
commercialization and marketing of MycoVa(tm) in Canada following receipt of
regulatory approval by Health Canada.
More About MycoVa(tm)
In a 2009 Phase III clinical comparator study, MycoVa(tm) was determined to be no
less effective than Loceryl(r) in curing nail fungus. In this study, 1,029
patients with mild to moderate nail fungus were given either MycoVa(tm) (topical
10% terbinafine hydrogen chloride formulation) or Loceryl(r) (5% amorolfine nail
laquer) for 48 weeks. The primary endpoint was a complete cure, and the
secondary endpoints were killing the fungus and improving the appearance of the
nail. A formal reanalysis of initial study results showed no significant
difference in either primary or secondary endpoints between MycoVa(tm) and
Loceryl(r). Loceryl(r) is a registered trademark of Galderma.
MycoVa(tm) was also the subject of two Phase 3, randomized, double-blind, vehicle
controlled, multicenter, parallel group studies to assess the efficacy, safety,
and tolerability of MycoVa(tm). A combined, post-hoc analysis of these two Phase
III clinical studies, completed by Apricus Bio in 2011, demonstrated
statistically significant results in mycological cure, resulting in the
eradication of nail fungus in favor of MycoVa(tm) treatment in patients that did
not present with comorbid tinea pedis (athlete's foot).
In the Company's view, MycoVa(tm) has distinct advantages over Loceryl(r) for nail
fungus suffers. MycoVa(tm) is simple and easy to apply, which could greatly
improve patient compliance. The product is applied directly to the infected
nails, typically at bedtime, accompanies by a simple washing with soap and
water. The formulation allows significant amounts of the active ingredient to
penetrate through the nail plate to the nail bed and surrounding area where
fungus is located without significant systemic exposure. By contrast, Loceryl(r)
requires more patient care before applying the lacquer, including filing the
affected areas of nail, including the nail surfaces, as thoroughly as possible.
The surface of the nail should then be cleansed using disposable swabs. The
nail lacquer is then applied onto the entire surface of the infected nail(s)
using reusable applicators. Before repeat application of Loceryl(r), the affected
nails should be filed down again and wiped with a cleansing pad to remove any
residual lacquer.
About Onychomycosis
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.
About Apricus Biosciences, Inc.
Apricus Bio is a San Diego-based revenue-generating 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 NexACT(r) 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.
Apricus Bio currently markets Totect(r) (dexrazoxane HCl), the only drug approved
in the US for the treatment of anthracycline extravasation. The Company also
plans to market in the U.S. or certain other countries the following products:
(a) Granisol(r) (granisetron HCI) oral solution, the only FDA-approved, oral,
ready-to-use liquid solution of granisetron, (b) Aquoral(tm), an FDA-cleared,
prescription-only spray for the treatment of Xerostomia (the medical term for
dry mouth due to a lack of saliva) and (c) NitroMist(tm) (nitroglycerin sublingual
spray), an FDA-approved 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).
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 products and
product candidates, to have its products and product candidates such as
Femprox(r) and MycoVa(tm) receive patent protection and be approved by relevant
regulatory authorities, to successfully commercialize such products as Totect(r)
, Granisol(r) , Aquoral(tm) and NitroMist(tm) and Vitaros(r) for erectile dysfunction and
NexACT(r) product candidates and drug delivery technology 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.
CONTACT: Apricus Bio Investor Relations:
David Pitts
Argot Partners
212-600-1902
david@argotpartners.com
News Source: NASDAQ OMX
11.05.2012 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
---------------------------------------------------------------------------