Germany's Federal Institute for Drugs and Medical Devices
(BfArM) granted national phase approval to
Apricus Biosciences, Inc.
) Vitaros for the treatment of erectile dysfunction.
Vitaros is the only approved product at Apricus. In Jun 2013,
Apricus received approval for Vitaros under the European
Decentralized Procedure (DCP). Apricus' marketing approval
application for Vitaros designated the Netherlands as the
Reference Member State (RMS) on behalf of nine other European
Concerned Member States (France, Germany, Italy, UK, Ireland,
Spain, Sweden, Belgium and Luxembourg) that participated in the
Apart from Germany, Apricus now has national phase approvals
for Vitaros in Ireland, the Netherlands, Sweden and the UK.
We note that Apricus reported research and development
expenses of $1.5 million in the second quarter of 2013, up 49%
year-over-year. Expenses were driven by increased consulting
services and higher expenses associated with the manufacture and
regulatory filings for Vitaros.
The company currently focuses on the launch of Vitaros and the
development of Femprox (female sexual interest / arousal
disorder). The company divested multiple non-core assets and
streamlined its global operations to focus on the above areas.
Earlier in the year, Apricus raised $17.1 million through a
public offering of common stock and warrants primarily for the
We note that Apricus has several partnership agreements for
Vitaros in countries like the U.S., Canada, Germany, UK, Italy
and Israel. Furthermore, Apricus is looking to enter into
partnerships in the unpartnered markets.
Apricus carries a Zacks Rank #2 (Buy). Currently, companies
which look attractive include
) with a Zacks Rank #1 (Strong Buy), and
Alexion Pharmaceuticals, Inc.
) with a Zacks Rank #2 (Buy).
ACTELION LTD (ALIOF): Get Free Report
ALEXION PHARMA (ALXN): Free Stock Analysis
APPRICUS BIOSCI (APRI): Free Stock Analysis
CEMPRA INC (CEMP): Free Stock Analysis Report
To read this article on Zacks.com click here.