SAN DIEGO--(BUSINESS WIRE)-- Apricus Biosciences, Inc. (“Apricus Bio”) (NASDAQ: APRI), announced today that it has appointed a manufacturer for Vitaros®, its new treatment for erectile dysfunction (ED), which was approved for marketing by Health Canada on November 12, 2010. Specifically, the Therapex Division (http://www.therapex.com/corporate.html) of E-Z-EM Canada, Inc., a wholly-owned subsidiary of Bracco Pharma in Italy, will manufacture the product for Apricus Bio. Therapex will also be the designated manufacturer when Apricus Bio files for marketing approval in Europe for Vitaros, which is expected in the first half of 2011. The Company intends to move forward with production of Vitaros in parallel to ongoing partnering discussions, in order to accelerate the planned commercial launch of the drug.
Vitaros differs from other existing ED 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. “Its 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. Vitaros is the first topical ED treatment that clinically works with an excellent side effect profile,” said Dr. Bassam Damaj, Apricus Biosciences’ President and Chief Executive Officer.
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.
Alprostadil is a well recognized drug for treating ED, and 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®.
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.
Viagra® is a registered trademark of Pfizer, Inc, Cialis® is a registered trademark of Lilly, USA and Levitra® is a registered trademark of Bayer A.G. Vitaros® is a registered trademark in Canada held by Apricus Bio; Vitaros® is a registered trademark in the U.S., held by Warner Chilcott Company.
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 and the timing and success of the commercial launch of Vitaros in Canada. 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, 858-848-4249
V.P. Investor Relations &
Rx Communications Group, LLC
Paula Schwartz, 917-322-2216
KEYWORDS: United States North America Canada California
INDUSTRY KEYWORDS: Health Biotechnology Pharmaceutical