Apricus Biosciences, Inc.
05.04.2011 18:36
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SAN DIEGO, 2011-04-05 18:36 CEST (GLOBE NEWSWIRE) —
Apricus Biosciences, Inc. (–Apricus Bio–) (Nasdaq:APRI)
(http://www.apricusbio.com) announced today that Chairman, President and Chief
Executive Officer, Dr. Bassam Damaj, was recently interviewed by
WallStreetCorner.com, a New York-based financial publication. The interview is
available at http://wallstreetcorner.com/daily.html.
In the interview, Dr. Damaj provided an update on Apricus Bio–s recent
developments and plans. He noted that, based in San Diego, Apricus Bio is a
revenue-generating pharmaceutical company. Its clinically-validated NexACT(r)
drug delivery technology enables multi-route administration of new and improved
compounds across numerous therapeutic classes. Revenues and growth are driven
from out-licensing of its technology for the development and commercialization
of those compounds to pharmaceutical and biotechnology companies worldwide.
Apricus is also monetizing its existing product pipeline, including its lead
product, Vitaros(r), approved in Canada in November 2010 for the topical
treatment of erectile dysfunction, and which is expected to be available on the
Canadian market later this year. The company–s pipeline also includes compounds
in development from the pre-clinical stage through Phase III. These drugs are
focused on sexual dysfunction, oncology, dermatology, autoimmune, pain,
anti-infectives, diabetes, cosmaceuticals, and others.
Dr. Damaj noted that the company is in late-stage discussions with several
major pharmaceutical companies in Canada to commercialize its lead product,
Vitaros(r), in that market, and currently expects to sign a commercial
partnership for Canada in Q2 2011. Apricus Bio expects to sign additional
commercialization partnership deals in the second half of 2011 and anticipates
receiving royalty revenues from sales of the product possibly during the second
half of 2011 or the first half of 2012, Dr. Damaj said.
–We also plan to file for approval for Vitaros(r) in Europe in the first half of
2011,– said Dr. Damaj. –Further, our expectation is to sign a commercialization
partnership similar to Canada for a number of the major European countries in
2011. We have already signed a partnership in Italy with Bracco, whereby we
expect to receive [Eur]750,000 before the end of Q2 2011. We believe that if
Vitaros(r) is approved in Europe in late 2012, we will begin to receive royalty
revenues beginning in 2013 for the major markets described above,– he added.
In the interview, Dr. Damaj pointed out that Apricus Bio also holds the
worldwide rights to Femprox(r), a topical treatment for female sexual
dysfunction. Like Vitaros(r), it contains a previously approved sexual
dysfunction drug, alprostadil. Apicus Bio–s proprietary NexACT(r) technology
allows medication to be delivered topically, through the skin, for fast
efficacy and fewer side effects than oral medications.
Regarding Femprox(r), Dr. Damaj said, –We have already completed one Phase II
trial in the U.S. and one Phase III study in close to 400 women in outside the
U.S., which achieved a 44% positive response rate as compared to a placebo. We
plan to meet with the U.S. Food&Drug Administration in order to agree on the
planned Phase III clinical program required for marketing approval in the U.S.
We are also planning to meet with Canadian agency officials to seek guidance as
to whether the current Phase III trial will be sufficient for filing a New Drug
Submission (–NDS–) in Canada.–
As for the size of the market for Femprox(r), Dr. Damaj stated, –To our
knowledge, there aren–t any approved products in any major market to treat
female sexual arousal disorder, a persistent or recurring inability to attain,
or maintain adequate sexual excitement, causing personal distress. It is
estimated that there are approximately 50 million potential sufferers in the
U.S. alone, according to Fitzheny and Sandberg in 2005. The market value in the
U.S. could exceed $4 billion, with only 15% of patients captured on therapy.–
Asked to provide an overview of Apricus Bio, Dr. Damaj said, –We currently
focus our efforts on new and patented pharmaceutical products. They are mostly
based on our patented drug delivery technology known as NexACT(r). We leverage
the know-how of our CRO (Clinical Research Organization) business to assist in
our product and NexACT(r) technology development. In 2010, through the
acquisition of Bio-Quant, we expanded our R&D capabilities with NexACT(r) into
the areas of oncology, inflammation, immunology, and metabolic diseases.–
In addition, Dr. Damaj said, –We intend to continue our efforts developing
topical treatments based on the application of the NexACT(r) technology to drugs:
(1) previously approved by the U.S. Food and Drug Administration; (2) with
proven efficacy and safety profiles; (3) with patents expiring in the near
term, or expired; and, (4) with proven market track records and potential.–
–Other products in the Apricus Bio pipeline include PrevOnco?, for liver cancer
and MycoVa? for the treatment of fungal nail infection (onychomycosis),– Dr.
Damaj noted.
In addition, Dr. Damaj said that Apricus Bio has recently appointed a Sexual
Dysfunction Clinical Advisory Board. –It consists of such key opinion leaders
as Irwin Goldstein, M.D., Jed Kaminetsky, M.D., and Ajay Nehra, M.D. We are
pleased that Drs. Goldstein, Kaminetsky and Nehra have agreed to serve on this
new Board. Their expertise will be key to helping us move forward with our
Femprox(r) program as well as in the development of other products in the male
and female sexual dysfunction field,– Dr. Damaj added.
Apricus Bio–s Forward-Looking Statement Safe Harbor
Statements under the Private Securities Litigation Reform Act, as amended: 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, its ability to obtain and/or develop products
from its patented technology and to successfully enter into partnership,
licensing or commercialization agreements for its Vitaros(r) product for erectile
dysfunction and its NexACT? platform technology. 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, subsequent quarterly reports filed on Form
10-Q and other filings made with the SEC. Copies of these reports are available
from the SEC–s website or without charge from the Company.
Apricus Biosciences, Inc.
Edward Cox, V.P.
Investor Relations&Corporate Development, Apricus Bio, Inc.
(858) 848-4249
ecox@apricusbio.com
Apricus Bio Investor Relations
Paula Schwartz
Rx Communications Group, LLC
(917) 322-2216
pschwartz@rxir.com
News Source: NASDAQ OMX
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Language: English
Company: Apricus Biosciences, Inc.
United States
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ISIN: US9901429525
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