Apricus Biosciences, Inc.
) recently received a negative opinion from Swissmedic, the
Agency for Therapeutic Products in Switzerland. Swissmedic is not
in favor of granting marketing approval to Vitaros, indicated for
erectile dysfunction, based on some quality related issues.
The pre-clinical and clinical data submitted earlier by
Apricus was satisfactory for the approval according to
Swissmedic. However, according to Swissmedic the data related to
the targeted shelf life of the product's cold chain formulation
presented by Apricus was not satisfactory for the approval at
present. Apricus plans to submit an appeal regarding this within
Vitaros is the only approved product of Apricus. Vitaros is
approved in Canada and Europe.
Recently, Apricus got national phase approvals for Vitaros in
Ireland, the Netherlands, the UK and Sweden.
The company's main area of focus this year is the launch of
Vitaros and the clinical development of Femprox (female sexual
dysfunction treatment). During the first half of 2013, Apricus
raised $17.1 million through common stock and warrants. It also
divested multiple non-core assets and has streamlined its global
operations. This should allow the company to focus on Vitaros and
We note that Apricus has several partnership agreements for
Vitaros in countries like the U.S., Canada, Germany, UK, Italy,
and certain other countries in the Middle East, the Gulf
countries, and Israel. The company's near-term focus is to direct
resources toward the commercialization of Vitaros in Europe and
Canada with the help of its existing partners in these
Furthermore, Apricus is looking to enter into partnerships in
the remaining countries in Europe and global markets. Apricus
expects to earn license fees through these partnerships.
Apricus carries a Zacks Rank #3 (Hold). Currently, companies
which look attractive include
Gilead Sciences Inc.
) with a Zacks Rank #1 (Strong Buy), and
) with a Zacks Rank #2 (Buy).
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