DGAP-News: Apricus Biosciences Will Request Approval of Vitaros(R) as a Treatment for Erectile Dysfunction in Switzerland, Based on Guidance From Swiss Regulatory Authorities
ID: 409357
19.05.2011 14:45
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SAN DIEGO, 2011-05-19 14:45 CEST (GLOBE NEWSWIRE) --
Apricus Biosciences, Inc. ('Apricus Bio') (Nasdaq:APRI) announced today that it
will file a marketing application in Switzerland for Vitaros(r) as a treatment
for patients with erectile dysfunction ('ED'), based on a positive response it
has received from Swissmedic, the Swiss Agency for Therapeutic Products.
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. Switzerland, however, is not part
of the European Medicines Evaluation Agency ('EMEA'). Marketing drugs in that
country requires an independent application and approval from Swissmedic.
Apricus asked the Swiss agency for guidance on whether to file an application,
and received an affirmative response. The Company expects to file the
application in the next two to three months.
'A Swissmedic approval could support approvals for Vitaros(r) for the treatment
of ED in several other European countries, like Switzerland that are not
members of the European Union,' says Dr. Bassam Damaj, Chairman, Chief
Executive Officer and President of Apricus Bio. 'The filing in Switzerland is
another step for us to achieve our goal of making Vitaros(r) available in as many
countries as possible.'
The Company has previously 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 other regulatory news regarding another of Apricus Bio's products, the
Company has received a preliminary letter from the U.S. Food and Drug
Administration ('FDA') related to the orphan drug designation request filed for
Apricus Bio's RayVa? product for the treatment of Raynaud's phenomenon in
patients with systemic sclerosis. The FDA has requested additional information
on the number of patients, as well as a plan to limit the potential use of
RayVa? by other patients who do not suffer from this condition.
About Vitaros(r) for ED
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 pharmaceutical 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, to have its products such as Vitaros(r), RayVa? among others
and product candidates approved by relevant regulatory authorities, 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.
Corporate Development&Investor Relations, Apricus Biosciences, 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
19.05.2011 Dissemination of a Corporate News, transmitted by DGAP -
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The issuer is solely responsible for the content of this announcement.
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Language: English
Company: Apricus Biosciences, Inc.
United States
Phone:
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Internet:
ISIN: US9901429525
WKN:
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Datum: 19.05.2011 - 14:45 Uhr
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News-ID 409357
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