DGAP-News: Apricus Biosciences Announces Intent to File NDS for MycoVa(TM) in Canada
(firmenpresse) - Apricus Biosciences, Inc.
01.10.2012 12:00
---------------------------------------------------------------------------
Health Canada Agrees to Review of Existing Phase 3 Clinical Data Package Based
on the Re-Analysis of the Secondary Endpoints
SAN DIEGO, 2012-10-01 12:00 CEST (GLOBE NEWSWIRE) --
Apricus Biosciences, Inc. ('Apricus Bio' or the 'Company') (Nasdaq:APRI)
(http://www.apricusbio.com) announced today its intent to file a New Drug
Submission ('NDS') in Canada for MycoVa(tm), the Company's topical treatment for
onychomycosis.
On July 18, 2012, Apricus Bio participated in a pre-NDS meeting with Health
Canada, the agency responsible for approving drugs in Canada. Based on the
agency's review of the submitted data package for MycoVa(tm), Health Canada
concurred that the re-analysis of existing Phase 3 development program data by
disease severity is acceptable to support an NDS filing and review in Canada.
In multiple Phase 3 clinical studies, the Company's MycoVa(tm) product
successfully demonstrated its ability to kill nail fungus and improve the
appearance of the nail, but it did not meet its primary endpoint: complete
cure. Given these results, Health Canada has agreed to review in the NDS the
use of these successful secondary endpoints re-analyzed by disease severity to
demonstrate the efficacy of MycoVa(tm). Apricus Bio expects to file the New Drug
Submission ('NDS') for MycoVa(tm) in the fourth quarter of 2013 once the
accelerated stability is completed at its new manufacturer.
'Our meeting with Health Canada confirms the value of this product and our
assessment of our MycoVa(tm) clinical dossier, based on the re-analysis we did on
the data from three Phase 3 clinical studies,' said Bassam Damaj, Ph.D.,
President and Chief Executive Officer of Apricus Bio. 'At the Pre-NDS meeting,
Health Canada supported the filing of a NDS seeking marketing approval in
Canada based on the existing clinical data. We will continue to move forward
with preparations for filing, approval, and commercialization of MycoVa(tm) in the
Canadian market. The agreement with Health Canada on filing the NDS relates to
the Company's second drug containing our proprietary NexACT(r) delivery
technology and if approved further validates not only the value of our platform
but its clinical effectiveness,' continued Dr. Damaj.
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. The Company is also currently seeking
guidance re MycoVa(tm) from the European Medicines Agency for eventual submissions
in that region.
MycoVa(tm) Clinical Development Program
In a 2009 Phase 3 clinical comparator study, MycoVa(tm) was found to be no less
effective than Loceryl(r) in curing nail fungus. Loceryl(r) is currently the
topical standard of care for onychomycosis in Europe. In this study, 1,029
patients with mild to moderate nail fungus were given either MycoVa(tm) (topical
10% terbinafine hydrochloride 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 by the Company 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 3
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).
More About MycoVa(tm)
MycoVa(tm) is a topically applied formulation of terbinafine hydrochloride, a
well-known medication for nail fungus, delivered with 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.
In the Company's view, MycoVa(tm) has distinct advantages over Loceryl(r) for nail
fungus sufferers. 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, accompanied 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.
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 (Nasdaq:APRI) is a pharmaceutical company that develops and markets
innovative treatments that help large patient populations across numerous,
high-demand therapeutic classes. The Company has four approved products and has
developed a strong pipeline of multiple late-stage product opportunities. With
commercial operations in both the U.S. and Europe (France), Apricus Bio
generates revenues and growth from sales of its commercial products and by
out-licensing, in certain territories, its pipeline products and NexACT(r)
technology.
Apricus Bio's growth strategy is to acquire, develop, and commercialize new
products through strategic partnerships. The Company currently has commercial
partnerships with multiple large pharmaceutical companies including Novartis,
Abbott Laboratories, Sandoz, Takeda, Warner Chilcott and Bracco, and
co-promotes multiple products in France.
Apricus Biosciences is headquartered in San Diego, CA and is publicly traded on
the NASDAQ under the ticker symbol APRI.
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 MycoVa(tm)
receive patent protection and be approved by relevant regulatory authorities,
to successfully commercialize such products 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.
Apricus Bio Investor Relations:
David Pitts
Argot Partners
212-600-1902
david(at)argotpartners.com
News Source: NASDAQ OMX
01.10.2012 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
---------------------------------------------------------------------------
Themen in dieser Pressemitteilung:
Unternehmensinformation / Kurzprofil:
Datum: 01.10.2012 - 12:00 Uhr
Sprache: Deutsch
News-ID 188053
Anzahl Zeichen: 12862
contact information:
Kategorie:
Business News
Diese Pressemitteilung wurde bisher 192 mal aufgerufen.
Die Pressemitteilung mit dem Titel:
"DGAP-News: Apricus Biosciences Announces Intent to File NDS for MycoVa(TM) in Canada"
steht unter der journalistisch-redaktionellen Verantwortung von
Apricus Biosciences, Inc. (Nachricht senden)
Beachten Sie bitte die weiteren Informationen zum Haftungsauschluß (gemäß TMG - TeleMedianGesetz) und dem Datenschutz (gemäß der DSGVO).
