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.