Management of Apricus Bio Highlights Corporate Development, Drug Registration and Out-Licensing Progress at Two Biotech Conferences
SAN FRANCISCO, Jan. 12, 2011 (GLOBE NEWSWIRE) -- Dr. Bassam Damaj, President and Chief Executive Officer of Apricus Biosciences, Inc. ("Apricus Bio") (Nasdaq:APRI),today presented at the Fourth Annual OneMed Forum and Biotech Showcase 2011 in San Francisco, providing an overall corporate update as well as reporting on on-going plans to out-license and commercialize the Company's Vitaros® topical cream, which was recently approved by Health Canada to treat erectile dysfunction ("ED"), and the research and development efforts relating to additional products that utilize NexACT®, the Company's proprietary multi-route drug delivery technology.
Dr. Damaj noted, "Our goal is to out-license our proprietary NexACT technology for the delivery of various medications to pharmaceutical and other biotech companies for use with their proprietary compounds. I believe we are making excellent progress in this area and we are currently talking to a number of companies about ways in which they can utilize the NexACT technology to improve the efficacy of select products. Our immediate goals also include initiating pre-filing guidance meetings with the respective health agencies to file for market authorization in Canada and Europe for additional NexACT products, such as MycoVaTM and Femprox®."
Dr. Damaj continued, "Health Canada granted marketing approval for Vitaros, our proprietary, topically-applied, on-demand treatment for ED which incorporates the Company's NexACT technology, as a first-line therapy for erectile dysfunction, in November 2010. Our intention is to move forward with production in parallel with ongoing partnering discussions, in order to accelerate the planned commercial launch of the drug."
In his presentations, Dr. Damaj also noted that, as previously announced, Apricus Bio has entered into a licensing agreement granting Bracco SpA the exclusive rights to market Vitaros in Italy. Under the terms of the licensing agreement, Bracco has been granted exclusive rights in Italy to commercialize and market Vitaros under the Bracco trademark, and Apricus Bio is entitled to receive up to €5.5 million in up-front, regulatory and sales milestone payments. Further, over the life of the agreement, Apricus Bio will receive tiered, double-digit royalties based on Bracco's sales of the product.
An application for approval to market Vitaros in Europe is currently scheduled to be filed in the second quarter of 2011. In addition, Apricus Bio recently announced an out-licensing agreement for Vitaros with Elis Pharma for the Gulf Countries and part of the Middle East. Specifically, under the terms of the agreement, Elis has exclusive rights in The Gulf Countries and part of the Middle East (including, Lebanon, Syria, Jordan, Iraq and Yemen) to commercialize and market Vitaros. Apricus Bio is entitled to receive up to $2.1 million in payments for signing, regulatory and sales milestones.
In his presentations, Dr. Damaj discussed Apricus Bio's efforts to partner Vitaros throughout other parts of Europe, Africa and South America. He also reviewed the continuing development of Apricus Bio's other advanced products in its pipeline that are in or are entering Phase II/III development, such as RayVaTM for Raynaud's syndrome and PrevOncoTM for liver cancer. Dr. Damaj reiterated that the Company filed the SPA for its proposed Phase III trials for PrevOnco with the FDA and expects a response the week of January 17, 2011. In addition, the Company is developing a NexACT proprietary Lansoprazole formulation to utilize in its proposed PrevOnco Phase III trial.
In addition to these products, Dr. Damaj discussed eight other products in the Company's pipeline which are now in development for various indications such as, dermatology, autoimmune/anti-inflammatory/pain, anti-infectives and cosmeceuticals, diabetes, sexual dysfunction, cancer and others.
A recorded video of Dr. Damaj giving the corporate update can be accessed via the following link: http://www.youtube.com/user/Apricusbio?feature=mhum#p/u/0/SjJmTubb_O0
About Apricus Biosciences, Inc.
Backed by NexMed, USA and Bio-Quant, Inc., its revenue generating CRO business, Apricus Bio 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. Future growth is expected to be driven primarily through out-licensing of this technology for the development and commercialization of such compounds to pharmaceutical and biotechnology companies, worldwide. Concurrently, the Company is seeking to monetize its existing product pipeline, including its approved drug erectile dysfunction treatment, Vitaros, as well as compounds in development from pre-clinical through Phase 3, currently focused on dermatology, sexual dysfunction and cancer. For further information on Apricus Bio and its subsidiaries, visit http://www.apricusbio.com.
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, timing for seeking foreign approvals for Vitaros, FDA approval for the PrevOnco trials, timing and success of the commercial launch of Vitaros in Italy and The Gulf Countries and part of the Middle East, the ability to develop and commercialize the Company's products on its own and with partners and the ability to meet its milestones. 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
(858) 848-4249
[email protected]
Apricus Bio Investor Relations
Paula Schwartz
Rx Communications Group, LLC
(917) 322-2216
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