Germany's Federal Institute for Drugs and Medical Devices (BfArM) granted national phase approval to Apricus Biosciences, Inc.’s (APRI) 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 procedure.
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 above purpose.
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 Actelion Ltd. (ALIOF) with a Zacks Rank #1 (Strong Buy), and Cempra, Inc. (CEMP) and Alexion Pharmaceuticals, Inc. (ALXN) with a Zacks Rank #2 (Buy).Read the Full Research Report on APRI
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