SAN DIEGO, May 10, 2013 (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc. ("Apricus Bio" or the "Company") (Nasdaq:APRI) (http://www.apricusbio.com), today provided an update regarding ongoing corporate activities and announced that it expects to file its Quarterly Report on Form 10-Q for the quarter ended March 31, 2013 with the Securities and Exchange Commission on Friday, May 10, 2013. As previously announced, the Company will host its first quarter 2013 financial results conference call today, May 10, 2013 at 9:00 a.m. ET.
"Apricus Bio began 2013 with a newly focused corporate strategy aimed at the commercialization, through partnerships, of its lead product Vitaros® for erectile dysfunction ("ED") and the development of its lead product candidate Femprox® for female sexual arousal disorder ("FSAD")," said Richard Pascoe, Chief Executive Officer of Apricus Bio. "Since the beginning of the year, we have made important progress in support of that goal, including the successful divestiture of multiple non-core assets, streamlining of our operations to better align them with our objectives, and advancement of our regulatory and commercial strategy for Vitaros® and Femprox®. We continue to believe that the greatest opportunity for shareholder value creation remains in the global development and commercialization, through strategic partnerships, of these lead assets."
Recent Corporate Developments
- European approval decision for Vitaros® in Europe via the Decentralized Procedure ("DCP"). We are currently awaiting a decision regarding the approval of Vitaros® in Europe via the DCP with The Netherlands serving as the Reference Member State ("RMS"). In April of 2013, Apricus Bio, in consultation with our European commercialization partners, submitted to the RMS our response to the Day 120 List of Questions ("LOQ"). This week, which marked Day 180 of the regulatory approval process, the RMS confirmed that the major nonclinical, clinical and clinical safety issues outlined in the Day 120 LOQ have been resolved. While the regulatory review process is ongoing, and we remain in active dialogue with the RMS on certain remaining matters included in the Day 180 response, we believe that the marketing approval process for Vitaros® in Europe remains on track for an approval decision on Day 210 of the process assuming there are no other interruptions in the review process. If Vitaros® is approved by the RMS, our commercialization partners will commence with the National Phase approvals in their respective territories. Once those approvals are secured on a country-by-country basis, marketing of Vitaros® can then be initiated in each country by our commercialization partners. In Europe, existing ED products generated over $1 billion in sales in 2012 and Apricus Bio believes that a significant portion of the market remains untreated or undertreated, which represents a significant commercial opportunity for Vitaros®.
- Commercial Launch of Vitaros® in Canada. Vitaros® is approved in Canada, and Apricus Bio licensed Vitaros® to Abbott Canada for commercialization of the product in that territory. Abbott remains fully committed to a successful launch of the cold-chain version of Vitaros® in Canada in the shortest timeframe possible. Abbott is working with their contract manufacturer to optimize the product's shelf-life period, which is driven by specifications that are applicable only to the product that will be sold in Canada, prior to launching the product in that market. As a result of these ongoing developments, Abbott has confirmed that a Vitaros® launch in Canada in the first half of 2013 will not occur.
- Femprox® Development Program: Femprox® is our lead product candidate for the treatment of female sexual arousal disorder, or FSAD. To date, we have completed seven clinical studies with Femprox® including a 100 patient Phase 2 study in the U.S. and a 400 patient Phase 3 study in China. The data generated from these studies strongly suggests that Femprox® has the potential to effectively treat FSAD in a female patient population where there are currently no available FDA approved treatment options. Moreover, we believe that Femprox® could be the first and only on-demand treatment approved for FSAD, where estimates of the market size are on par with that found in the erectile dysfunction market. The Company continues to advance the Femprox® development program in close consultation with our clinical and regulatory advisors. Our near-term goal is to seek confirmatory regulatory guidance from the U.S. FDA in the form of an End-of-Phase 2 meeting.
- Divestiture of Non-Core Assets: The Company sold its product, Totect® (dexrazoxane HCl), a marketed, injectable treatment for anthracycline extravasation, to Biocodex USA ("Biocodex") in March 2013, in line with its recently updated corporate strategy. Under terms of the arrangement, Apricus Bio received an upfront payment at closing and is eligible to receive royalties on net sales of Totect® by Biocodex through 2016, in exchange for Apricus Bio's sale of its commercialization rights to Totect® in North America and South America.
Conference Call Information
The call can be accessed in the U.S. by dialing 877-407-9210 and outside of the U.S. by dialing 201-689-8049 and asking the conference operator for the Apricus Bio Conference Call. The conference call will also be webcast live at http://www.investorcalendar.com/IC/CEPage.asp?ID=17095. The teleconference replay will be available for one week by dialing in the U.S. 877-660-6853 and outside of the U.S. by dialing 201-612-7415. Replay Passcode 413843 is required for playback. The webcast replay will be available for three months.
Vitaros®, Apricus Bio's lead product candidate for the treatment of ED, is a topically-applied cream formulation of alprostadil, a vasodilator, which directly increases blood flow to the penis, causing an erection. Alprostadil is a widely accepted alternative to the PDE5 inhibitors for difficult to treat patients, and Vitaros® is relatively safe and effective, and offers greater market opportunity due to its patient-friendly form versus both other alprostadil dosage forms and also relative to oral ED products. With a market affecting nearly 150 million men worldwide and representing approximately $2.6 billion in revenue – excluding the U.S. – Vitaros® represents a major market opportunity, particularly as a distinct product that addresses a significant underserved population.
Femprox® is a product candidate for the treatment of female sexual arousal disorder (FSAD). Seven clinical studies have been successfully completed to date, including one, 98-subject Phase 2 study in the US and a nearly 400-subject Phase 3 study in China. To date, no product has been approved in the U.S. to treat FSAD, a persistent or recurring inability to attain or maintain adequate sexual excitement, causing personal distress. Estimates of the FSAD market size put it on par with erectile dysfunction in males, and possibly larger.
About Apricus Biosciences, Inc.
Apricus Biosciences, Inc. (APRI) is a pharmaceutical company that develops and markets 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®, for the treatment of erectile dysfunction, which will be marketed in Canada by Abbott Laboratories, and Femprox®, a product candidate, for the treatment of female sexual arousal disorder.
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® for erectile dysfunction , and product candidates Femprox® for Female Sexual 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 and Canada and in other countries; to successfully commercialize such product and product candidates and other NexACT® product candidates and drug delivery technology through Abbott and its other licensees; to sell its oncology supportive care business or assets to a third party or parties; to cease funding to its French subsidiaries and to have such subsidiaries reorganize or liquidate successfully; 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.
Source:Apricus Biosciences, Inc.