Seelos Therapeutics Inc (SEEL)

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Apricus Biosciences' Marketing Application for Vitaros(R), for the Treatment of Erectile Dysfunction, is Accepted for Review in Europe

Date : 06/28/2011 @ 10:47AM
Source : GlobeNewswire Inc.
Stock : Apricus Biosciences, Inc. (APRI)

http://ih.advfn.com/p.php?pid=nmona&article=48233307&symbol=APRI

Apricus Biosciences, Inc. ("Apricus Bio") (Nasdaq:APRI) announced today that its marketing application for Vitaros®, indicated for the treatment of patients with erectile dysfunction ("ED"), has been accepted for review through the European Decentralized Procedure ("DCP").

In connection with the DCP, on April 28, 2011, the Company filed its application for marketing approval in multiple European countries, with the Netherlands serving as its Reference Member State ("RMS"). The RMS evaluated the application and has found it acceptable for review by the Company's chosen European Union countries for their individual consideration and approval. The DCP process takes approximately 240 days from the time of acceptance for review to final approval, and if approved, would give Apricus Bio the right to sell Vitaros® as a treatment for ED in multiple chosen countries within the European Union.

"We are very pleased that our marketing application for Vitaros® for ED has been accepted for review, as it speaks to the quality of the trials and clinical responses and is consistent with the guidance we received prior to filing," said Bassam Damaj, Ph.D., Chairman, President and Chief Executive Officer of Apricus. "We look forward to working with the European regulatory authorities in order to make Vitaros® available in Europe. In tandem, we are in the process of preparing a submission for Vitaros® for ED in Switzerland, in the near future. In addition, we are actively working with our current partner in Italy and with other potential European partners on the commercialization of the product in this region."

Vitaros® is approved in Canada for the treatment of ED. The Company's current plan is for commercial launch of the product in that country during the second half of 2011.

About Apricus Biosciences, Inc.

Apricus Bio, a San Diego based revenue-generating pharmaceutical company, has leveraged the flexibility of its clinically-validated NexACT® 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®, 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 and product candidates approved by relevant European and other regulatory authorities, to successfully commercialize such products and product candidates in Europe and other markets 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.
[phone]
[e-mail]

Apricus Bio Investor Relations
Paula Schwartz
Rx Communications Group, LLC
[phone]
[e-mail]

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http://www.finanznachrichten.de/nachrichten-2011-06/20645380-apricus-biosciences-marketing-application-for-vitaros-r-for-the-treatment-of-erectile-dysfunction-is-accepted-for-review-in-europe-016.htm