Apricus Biosciences, Inc.
19.07.2011 15:57
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SAN DIEGO, 2011-07-19 15:57 CEST (GLOBE NEWSWIRE) --
Apricus Biosciences, Inc. ('Apricus Bio') (Nasdaq:APRI) announced today its
filing of a marketing application for Vitaros(r) as a treatment for patients
with
erectile dysfunction ('ED') in Switzerland, with Swissmedic, the Swiss Agency
for Therapeutic Products. 'We are excited about making our third major filing
for our flagship product, Vitaros(r) for the treatment of ED,' said Dr. Bassam
Damaj, Chairman, Chief Executive Officer and President of Apricus Bio.
According to IMS Health data, the annual ED market in Switzerland in 2010 was
estimated at [Eur]27 million. The potential market for a drug approved in
Switzerland, however, is much larger than just the Swiss market. Swissmedic
approval is relied upon by the regulatory authorities in numerous European
countries that are not members of the European Union, as well as by many other
countries worldwide. The approval time for Swissmedic is currently
approximately 15 months from the time of submission.
The Company received marketing approval for Vitaros(r) as a first-line treatment
for ED from Health Canada in November 2010, for sales of the product in that
country. In April 2011, Apricus Bio 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.
Switzerland, however, is not part of the European Medicines Agency ('EMA').
Marketing drugs in Switzerland requires an independent application and approval
from Swissmedic. 'Swissmedic is considered one of the most well-respected drug
regulatory authorities that is relied on by many countries throughout the
world,' said Damaj. 'As we have stated previously, we look forward to applying
for approval for this product and for the ED indication in other important
international markets in the future.'
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 being 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 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 authorities
including Swissmedic, 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.
CONTACT: 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
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Language: English
Company: Apricus Biosciences, Inc.
United States
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ISIN: US9901429525
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DGAP-News: Apricus Biosciences Files Marketing Application for Vitaros(R) as a Treatment for Erectile Dysfunction in Switzerland
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