Apricus Biosciences Provides Vitaros(R) Swissmedic Update
SAN DIEGO, Aug. 29, 2013 -- Apricus Biosciences, Inc.
("Apricus Bio" or the "Company") (Nasdaq:APRI) (www.apricusbio.com), today announced that Swissmedic, the Agency for Therapeutic Products in Switzerland, has recommended against approval of marketing authorization for Vitaros(R) for the treatment of erectile dysfunction ("ED") based on certain quality related issues. Vitaros(R) is currently approved in Europe through the European Decentralized Procedure ("DCP") and in Canada as a first line treatment for ED.
In rendering their decision, Swissmedic informed Apricus Bio that the previously submitted pre-clinical and clinical data were satisfactory and would likely support an approval. However, the Agency also noted that the data provided by the Company pertaining to the targeted shelf life of the product's cold chain formulation was insufficient to support the approvability of Vitaros(R) at this time. The Company
intends to submit an appeal regarding this decision within thirty days.
"While we remain pleased that the safety and efficacy assessment of our pre-clinical and clinical data package supports the approval of Vitaros(R), we believe that we have sufficient grounds for an appeal, which we intend to pursue," said Richard Pascoe, Chief Executive Officer of Apricus Bio. "Moreover, we will continue to concentrate our
efforts on obtaining additional DCP national phase approvals for Vitaros(R), supporting the product's launch in the major European markets, and securing additional partnerships in available territories. We look forward to working closely with Swissmedic toward the goal of making Vitaros(R) available to ED patients across all of Europe."
The Company recently announced that, subsequent to DCP approval, Vitaros(R) has now received national phase approvals in Ireland, the Netherlands, Sweden and the United Kingdom. The Company continues to work independently, as well as with its commercialization partners, to obtain country-by-country national phase approvals in the remaining CMS territories including France, Germany, Italy, Spain, Belgium and
Luxembourg. Once the national phase approvals are secured on a country-by-country basis, marketing of Vitaros(R) can then be initiated in each country by Apricus Bio's commercialization partners.
Vitaros(R) has been approved for the treatment of Erectile Dysfunction
("ED") by the European Health Authorities and by Health Canada.
Vitaros(R) is a topically-applied cream formulation of alprostadil, a
vasodilator, combined with our proprietary permeation enhancer
DDAIP.HCL, which directly increases blood flow to the penis, causing an
erection. Alprostadil is a widely accepted alternative to the PDE-5
inhibitors for difficult to treat patients, and Vitaros(R), which was
determined to be safe and effective by the European Health Authorities
and previously by Health Canada, offers greater market opportunity due
to its patient-friendly form versus other alprostadil dosage forms and
also relative to oral ED products. With nearly 150 million men
worldwide who suffer from erectile dysfunction and an ED market size of
approximately $1 billion in revenue in Europe alone, Vitaros(R)
represents a major market opportunity for Apricus Bio and its
commercial partners given its unique product profile and its potential
to treat a large underserved population.
About Apricus Biosciences, Inc.
Apricus Biosciences, Inc. (APRI) is a pharmaceutical company that develops innovative treatments that help large patient populations across numerous, large-market therapeutic classes including male and female sexual health. The Company has one approved product, Vitaros(R), for the treatment of erectile dysfunction, which is now approved in
Europe and Canada and will be commercialized by Apricus Bio's marketing
partners, which include Abbott Laboratories Limited, Takeda Pharmaceuticals International GmbH, Hexal AG (Sandoz), and Bracco SpA.
Femprox(R), the Company's product candidate for the treatment of female
sexual interest and arousal disorder, has successfully completed a
nearly 400-subject proof-of-concept study.
For further information on Apricus Bio, visit
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 product Vitaros(R) for
erectile dysfunction, and product candidate Femprox(R) for Female
Sexual Interest and Arousal Disorder among others; to have its product
and product candidates receive additional patent protection and be
approved by relevant regulatory authorities in Europe, the United
States, Canada, Switzerland and in other countries, such as additional
national phase approvals for Vitaros(R) in the remaining CMS
territories; to successfully commercialize such product and product
candidates and other NexACT(R) product candidates and drug delivery
technology; 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
CONTACT: Apricus Bio Investor Relations:
David Pitts or Lourdes Catala