Friday, August 12, 2011 9:26:36 AM
Date : 08/11/2011 @ 11:33AM
Source : GlobeNewswire Inc.
Stock : Apricus Biosciences, Inc. (APRI)
http://ih.advfn.com/p.php?pid=nmona&article=48797110
Apricus Biosciences, Inc. ("Apricus Bio" or the "Company") (Nasdaq:APRI) (http://www.apricusbio.com) announced today that Chairman, President and Chief Executive Officer, Dr. Bassam Damaj, was interviewed recently by the CEOLIVE financial network (http://ceolive.tv/). The interview is available at the following link: http://www.youtube.com/user/Apricusbio#p/u/19/xD0UCcm2swo.
During the interview, Dr. Damaj reported on plans for the Company's pipeline, including the proposed commercialization in Canada and Europe of Vitaros®, a topical treatment for erectile dysfunction.
Dr. Damaj stated that, while Apricus Bio is negotiating both individual and bundled partnership agreements relating to Canada and Europe, the Company is also proceeding with manufacturing, scale-up and commercial batches of the drug for Canada, where the drug has already been approved. As previously stated, the Company expects Vitaros® to be available to patients in Canada later this year. Commenting on the option of bundling Canada and Europe into a single partnership deal, Dr. Damaj noted that the market sizes for erectile dysfunction are currently estimated to be approximately $180 million in Canada, and more than $1 billion in Europe. The potential to sign a deal that would cover both Europe and Canada has attracted a greater amount of competition for the product and may allow a European partnership to be finalized earlier than originally expected.
As with other drugs in Apricus Bio's pipeline, Vitaros®, which incorporates the active ingredient, alprostadil, utilizes the Company's patented NexACT® drug delivery technology to enhance the systemic absorption of a drug through the skin barrier.
During the CEOLIVE interview, Dr. Damaj also reviewed the Company's progress with respect to Femprox® (containing a combination of alprostadil and DDAIP ), for the treatment of female sexual arousal disorder ("FSAD"). Specifically, Dr. Damaj noted that Apricus Bio is currently seeking guidance from regulatory authorities in Europe, Canada and the U.S., with the goal of potentially filing for approval in those countries and regions. To date, Apricus Bio has completed one Phase III study in close to 400 women in China, which achieved a statistically significant response rate for all primary and secondary endpoints.
To the Company's knowledge, there are currently no products approved for FSAD in the U.S., and by some projections, the annual market there may be as large as $4 billion, annually.
Dr. Damaj also provided an update on MycoVa™, for which the Company owns global rights. MycoVa™ combines terbinafine, an existing, approved drug for onychomycosis (nail fungus), with the Company's NexACT® technology, in order to enhance the absorption of the drug through the nail bed. Apricus Bio has previously stated that, based on a reanalysis of prior data, it plans to seek regulatory approval guidance in order to potentially market the product as a treatment for nail fungus, excluding patients with Tinea Pedis (athlete's foot), in Europe and North America. In particular, Apricus Bio has produced a statistically significant reanalysis of its U.S. Phase III data which indicated that MycoVa™ is able, over an extended period of time, to kill the infecting fungus in patients with mild to moderate dermatophyte onychomycosis (excluding patients with Tinea Pedis) at the same level of effectiveness as the current European standard of care and at similar levels to U.S. topical treatments.
About Apricus Biosciences, Inc.
Apricus Bio, a San Diego-based, revenue-generating, biopharmaceutical 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 products and product candidates such as Vitaros®, to have its products and product candidates such as Vitaros® 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 Bio, Inc.
(858) 848-4249
ecox@apricusbio.com
Apricus Bio Investor Relations
Paula Schwartz
Rx Communications Group, LLC
(917) 322-2216
pschwartz@rxir.com
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