SAN DIEGO, Aug. 4, 2011 (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc. ("Apricus Bio" or the "Company") (Nasdaq:APRI) (http://www.apricusbio.com) announced today a corporate mid-year update covering Company activities, expected near-term events and comments on recent market conditions, as follows:
Vitaros®
The key focus of the Company's management team has been, and continues to be, partnering Vitaros®, for the treatment of erectile dysfunction (ED), in Canada, Europe, and internationally; ramping up the manufacturing process for Vitaros® for erectile dysfunction (ED), and; ensuring that Vitaros® launches in the Canadian market by the end of this year.
Dr. Bassam Damaj, the Chairman, President and Chief Executive Officer of Apricus Bio, noted, "Our partnership negotiations for Vitaros® are proceeding on a timely basis and we are confident that we will complete and announce our partnership for Canada, and potentially for Europe, in the near future. As we have stated previously, we are in multiple, late-stage partnership negotiations with various pharmaceutical companies for a range of territories and combinations. Our goal is to negotiate the most advantageous deal in each territory, both in upfront financial terms and to ensure that each partner has the capability to launch the product and achieve the sales and market penetration that we believe is warranted. We believe that our shareholders will be pleased, both in terms of the economics of our partnerships and the caliber of our partners for these territories, once announced."
He continued, "We are also pushing, full-steam ahead with the scale up of Vitaros® manufacturing. We have already completed our engineering batches, and commercial batches are expected to be completed before the end of the year. In parallel, the Company continues with its development of the room-temperature formulation of Vitaros® for ED, as previously announced, and we have requested guidance from Health Canada on the regulatory path required for approval.
"As stated earlier, we currently anticipate that Vitaros® will be introduced in Canada by the end of this year, though we may make it available online prior to the launch, pending discussions with our partner. We believe that the market will be pleased, both in terms of the economics of our partnerships and the caliber of our partners for these territories, once announced."
Femprox® and MycoVa™
With regard to Femprox®, for the treatment of female sexual arousal disorder ("FASD"), and MycoVa™, a topically-applied treatment for onychomycosis, or nail fungus, Dr. Damaj noted that the Company is continuing to work with its Clinical Advisory Boards and health regulatory agencies with regard to guidance on if, and when, the Company can file for marketing approvals in various territories.
Specifically, the Company is currently moving forward with guidance from health agencies in Europe and Canada in order to file for market authorization for Femprox® in those markets. In the U.S., Apricus Bio intends to request a meeting with the U.S. Food & Drug Administration (FDA) in order to come to agreement on the second Phase III trial required before potential market authorization.
"As for MycoVa™," Dr. Damaj stated, "despite the fact that the drug did not show efficacy in a previously conducted Phase III trials in the general onychomycosis patients population, the successful and statistically significant reanalysis of our U.S. Phase III data has indicated that MycoVa™ is able, over an extended period of time, to kill the infecting fungus in 20% of patients with mild to moderate dermatophyte onychomycosis (excluding patients with Tinea Pedis, or athlete's foot) and is as effective as for the treatment of nail fungus as the current European standard of care, Loceryl® (an ointment made by Galderma) and Penlac® (an ointment made by Sanofi-aventis). As such, we plan to seek regulatory approval guidance in order to potentially market the product as a treatment for nail fungus in Europe and North America. If successful, this strategy may eliminate the time and costs to run an additional Phase III trial. Moreover, if approved, MycoVa™ has the potential to represent the first FDA-approved drug for which Apricus Bio would own the global rights."
Finally, commenting on the macro environment, Dr. Damaj stated, "The overall market, and in particular, the small cap biotech sector, have been down significantly. Despite this, we are proud of the progress that Apricus Bio has made so far this year."
Second Quarter 2011 Conference Call Information
The Company also announced today that it will be holding its second quarter 2011 teleconference call to discuss financial and operating results for the three months ended June 30, 2011, at 4:00 pm ET on Monday, August 15, 2011 and will provide further information closer to that date regarding dial-in information.
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 subsidiary, please visit www.nexmedusa.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 develop Vitaros®, Femprox® and MycoVa™ and other products and product candidates, to have its products and product candidates approved by relevant European, U.S. and other regulatory authorities, to successfully commercialize such products and product candidates in Europe, the U.S. 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.