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Apricus Biosciences, Inc. Message Board

  • tombauer65 tombauer65 Dec 22, 2010 2:14 PM Flag

    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(R), 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 EURO5.5 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(R), Cialis(R) and Levitra(R) 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(R) 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 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.

    Just on the wires...

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