Apricus Biosciences, Inc.
08.08.2011 16:03
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Potential Market Size for Vitaros(R) for Erectile Dysfunction in Brazil, Alone,
is Approximately $347 Million, Based on IMS Health Data (2010)
SAN DIEGO, 2011-08-08 16:03 CEST (GLOBE NEWSWIRE) --
Apricus Biosciences, Inc. ('Apricus Bio') (Nasdaq:APRI) announced today that it
will file for market authorization to sell its erectile dysfunction drug,
Vitaros(r), in Latin America. The Company also stated that it has engaged the
services of Quintiles Global Regulatory Affairs, a leading international
regulatory consultancy, to prepare its regulatory filings for Vitaros(r) for
marketing approval in the following Latin American countries: Mexico, Brazil,
Argentina, Colombia, Chile and Peru. 'By preparing to file in Latin America, we
are moving forward with our plan to make Vitaros(r) available worldwide,' noted
Dr. Bassam Damaj, Chairman, President and Chief Executive Officer of Apricus
Bio.
According to IMS Health Data (2010), the potential market size for Vitaros(r)
for
ED in Brazil, alone, is approximately $347 million.
Apricus Bio has already prepared the necessary regulatory document -- known as
the Electronic Common Technical Document ('ECTD') -- to file for approval of
Vitaros(r) for ED throughout Latin America. Quintiles, a fully integrated
biopharmaceutical company offering commercial, consulting and capital solutions
worldwide, including a network of 22,000 professionals in 60 countries, will
provide additional guidance and regulatory advice in order to facilitate the
filings in each country. Specifically, Apricus Bio will utilize the services of
Quintiles Global Regulatory Affairs, comprised of an experienced and dedicated
team of approximately 45 regulatory experts, with decades of experience working
with international regulatory agencies--especially those in Latin America.
Apricus Bio currently expects that its first regulatory filing in Latin America
will be made within eight to 10 weeks. A number of other filings will be
submitted on or abut the same time. Approval requirements and timelines differ
across the six countries.
'We believe that the opportunities to sell our product in this region are
great, and the potential market sizes are substantial,' Damaj said. 'The
Company is now in the process of negotiating with a number of international and
regional pharmaceutical companies with sales and marketing teams in such
countries for commercialization partnerships throughout Latin America.'
Apricus Bio received marketing approval for Vitaros(r) as a first-line treatment
for ED from Health Canada in November 2011 for sales of the product in that
country. In April 2011, the Company filed a marketing application in the
European Union, under the Decentralized Procedure ('DCP'), for Vitaros(r) for
the
treatment of ED. Under the DCP, approval in a Reference Member State means that
a drug may be sold in all of the European Union countries that were filed with
the DCP as Concerned Member States. In July 2011, Apricus Bio filed for
regulatory approval with Swissmedic, the Swiss Agency for Therapeutic Products
for marketing of Vitaros(r) in that country.
About Vitaros(r) and the ED Market
The current leading drugs for erectile dysfunction are Viagra(r), Cialis(r) and
Levitra(r), which are taken in pill form and work by inhibiting an enzyme called
PDE5.
There is still a need for new, safe and effective treatments, however,
especially for those patients who cannot or do not respond well to oral
medication. Vitaros(r) differs from Viagra(r), Cialis(r) and Levitra(r) in two
ways.
Instead of a pill, Vitaros(r) is applied directly to the penis as a cream. The
topical application helps to reduce side effects and offers men who do not do
well with the existing drugs a patient-friendly alternative.
Second, Vitaros(r) operates by a different biochemical mechanism than oral ED
medications. It contains a previously marketed ED drug known by the chemical
name of alprostadil. When absorbed through the skin, alprostadil directly
boosts blood flow, thereby causing an erection within minutes, which the
Company believes is much faster than the results from the currently marketed
oral treatments.
Alprostadil is currently marketed as an injectable drug or as a suppository
inserted into the urethra. The key innovation behind Vitaros(r) is combining
alprostadil with Apricus Bio's NexACT(r) delivery technology, which allows the
drug to pass through the skin and makes the treatment much easier to apply.
In clinical studies, Vitaros(r) worked in patients suffering from mild to severe
ED, including men who did not respond to Viagra(r). The side effects reported
were localized and transient. 'We believe that Vitaros(r) will be an attractive
alternative to the oral PDE5 inhibitors for many patients with erectile
dysfunction,' stated Damaj.
Viagra(r) is a registered trademark of Pfizer, Inc.; Cialis(r) is a registered
trademark of Lilly, USA; Levitra(r), is a registered trademark of Bayer A.G.;
and
Vitaros(r) is a registered trademark in Canada held by Apricus Bio, and in the
U.S. held by Warner Chilcott Company.
About Apricus Biosciences, Inc.
Apricus Bio, a San Diego-based, revenue-generating biopharmaceutical company,
has leveraged the flexibility of its clinically-validated NexACT(r) drug
delivery
technology to enable multi-route administration of new and improved compounds
across numerous therapeutic classes.
Revenues and growth are driven from out-licensing of this technology for the
development and commercialization of such compounds to pharmaceutical and
biotechnology companies worldwide. In addition, the Company is seeking to
monetize its existing product pipeline, including its first product, Vitaros(r),
approved in Canada for the treatment of erectile dysfunction, which is
currently expected to be available on the Canadian market in 2011, as well as
compounds in development from pre-clinical through Phase III, currently focused
on Sexual Dysfunction, Oncology, Dermatology, Autoimmune, Pain,
Anti-Infectives, Diabetes and Cosmeceuticals among others.
For further information on Apricus Bio, visit http://www.apricusbio.com and for
information on its subsidiaries please visit www.nexmedusa.com or
www.bio-quant.com. You can also receive information at
http://twitter.com/apricusbio and http://facebook.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 development products and
product candidates such as Vitaros(r), to have its products and product
candidates such as Vitaros(r) approved by relevant regulatory including those in
the following Latin American countries: Mexico, Brazil, Columbia, Argentina,
Peru and Chile, to successfully commercialize such 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.
Apricus Biosciences, Inc.
Edward Cox, V.P.
Investor Relations & Corporate Development, 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
News Source: NASDAQ OMX
08.08.2011 Dissemination of a Corporate News, transmitted by DGAP -
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Language: English
Company: Apricus Biosciences, Inc.
United States
Phone:
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ISIN: US9901429525
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DGAP-News: Apricus Biosciences to File for Market Authorization to Sell Vitaros(R) for Erectile Dysfunction in Latin America
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