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
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...
know this...if the rest of the European deals are similar to the Italian deal, we should see over 80 million in royalty payments, besides of course the double digit ongoing royalty payments. Italy represents less than 10% of the European population:
Remember that the previous management gave away vitaros US for 2.5 million. In this deal our new mgmt team got 7.7 usd just for Italy! This sets up for many announcements of additional countries to follow. And remember this helps further validate Nextact technology which can be licenced to many other pharmas. Just the cash from this deal means no need to sell shares for another yr. Announce a few more, as is inevitable, and the co may never need to sell shares again unless there is a strategic use.
Exciting situation folks. $10 by End of Jan is not a pipe dream - post conferences and new investors. The market cap here is only 50 million or so!
5.5mio EUROS up-front and double-digit royalties... Not to bad for Italy alone i would say.
I expected a little bigger pop on this News, but it is what it is, it's just the beginning.
Nice X-Mas Gift anyway...
Molto bene molto bene folks.....and the good thing is that we are talking about euro so do your math:-).
Europe is a big market...hold this thing has big potential and for sure at this level is a buy...4 coming very soon,stay tuned.
Btw tale a look also at somx folks..i think these 2 stocks in 2011 will do very well!.
To tell you the truth I didt even get a chance to read the entire news just saw the "Apricus Bio is entitled to receive up to EURO5.5 million in up-front"
and jumped on it and bought more. I hope this will pan out for us longs!