Apricus Bio to Receive Up to EUR 5.5 Million, Plus Royalties
SAN DIEGO, Dec. 22, 2010 (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc. ("Apricus Bio") (Nasdaq:APRI), announced today that it has entered into a licensing agreement granting Bracco SpA ("Bracco") the exclusive rights to market Vitaros®, Apricus Bio's treatment for erectile dysfunction ("ED"), in Italy. On November 12, 2010, Apricus Bio announced that Health Canada had approved Vitaros for marketing as the first topical treatment for ED in that country. The application for approval to market Vitaros in Europe is scheduled to be filed in April 2011.
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.
Commenting on today's announcement, Dr. Bassam Damaj, President and Chief Executive Officer of Apricus Bio, stated, "We reached another major milestone in the history of this important product. This is the first in a series of commercialization agreements which we plan to execute for Vitaros. We look forward to working with Bracco and are confident in their ability to establish Vitaros as a major ED therapy. Given the company's proven success in building new markets, Bracco is a logical partner for launching this product in Italy."
About Vitaros and the ED Market
According to IMS Health data, the ED market in Italy was estimated at $192 million (for the 12 months ending October 31, 2010), which is the largest in Europe and dominated by oral PDE5 treatments. However, there is still a need for new, safe and effective treatments, especially for those patients who cannot or do not respond well to oral medication. Vitaros differs from oral PDE5 drugs like Viagra®, Cialis® and Levitra® in two ways. First, it is applied directly to the penis as a cream, instead of as a pill that is absorbed systemically. The topical application helps to reduce side effects and enables men who cannot take, or do not do well with the existing drugs, to have a patient-friendly alternative.
Second, Vitaros operates by a different biochemical mechanism than oral ED medications, and causes erections to occur in a more localized fashion and more quickly when compared to oral treatments. Vitaros contains a previously marketed ED drug, known by the chemical name of alprostadil. When absorbed through the skin, alprostadil, a vasodilator, directly boosts blood flow, thereby causing an erection. Clinical studies have shown that Vitaros works in a matter of minutes, compared to a reported onset time of 30 minutes or more for oral medications indicated for the treatment of ED. The side effects reported were localized and transient.
Alprostadil is currently marketed as an injectable drug or as a suppository inserted into the urethra. Apricus Bio incorporated alprostadil with its NexACT® delivery technology, resulting in a rapid and efficient topical delivery of the drug into the penis. In clinical studies, Vitaros worked in patients suffering from mild to severe ED, including men who did not respond to Viagra.
Viagra is a registered trademark of Pfizer, Inc.; Cialis is a registered trademark of Lilly, USA; Levitra, is a registered trademark of Bayer A.G.; Vitaros is a registered trademark in Canada held by Apricus Bio, and in the U.S. held by Warner Chilcott Company.
About the NexACT Drug Delivery Technology
Apricus Bio continues to add value to NexACT by expanding its potential applications from transdermal to subcutaneous, oral, buccal, rectal, nasal and ophthalmic. The Company recently announced confirmatory results qualifying NexACT as an anti-microbial preservative against a wide range of bacteria, fungus and mold. This could potentially unlock additional applications for the development of new pharmaceutical and cosmeceutical products.
About Bracco SpA
Bracco SpA is an international Group active in the healthcare sector through Bracco Imaging (diagnostic imaging), Pharma (prescription and over the counter drugs), Acist Medical Systems (medical devices and advanced imaging agents injection systems based in Minneapolis, USA), and the Centro Diagnostico Italiano (diagnostic clinic) in Milan. Bracco has more than 2,700 employees and annual total consolidated worldwide revenues of one billion Euros, of which approximately 65% is generated from international sales. In the Research and Development area, Bracco invests approximately 11% of reference turnover in the imaging diagnostics and medical devices sectors and has a portfolio comprising over 1,500 patents. For further information on Bracco and its subsidiaries, visit http://www.bracco.com.
About Apricus Biosciences
Backed by NexMed, USA and Bio-Quant, Inc., its revenue generating CRO business, Apricus Bio has leveraged the flexibility of its proven 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: 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, timing and success of the commercial launch of Vitaros in Italy and ability to execute additional commercialization agreements. 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 and subsequent quarterly reports filed on Form 10-Q. Copies of these reports are available from the SEC's website or without charge from the Company.
Ed Cox, V.P. Investor Relations & Corporate Development
Rx Communications Group, LLC
Apricus Bio Investor Relations:
Giuliano Faliva, Direttore Comunicazione e Immagine