Good news flowed in at Apricus Biosciences, Inc. (APRI) when the Italian Medicines Agency (:AIFA) gave national phase approval to the company’s sole approved product, Vitaros for the treatment of patients with erectile dysfunction (ED).
We note that in Jun 2013, Apricus received approval for Vitaros under the European Decentralized Procedure (:DCP). Following the Italian national phase approval, the drug has received six national phase approvals in Europe including Germany, Ireland, the Netherlands, Sweden, Italy and the U.K.
Gaining country by country national phase approval in the remaining territories (France, Spain, Belgium and Luxembourg). It is expected to gain those approvals by the first quarter of 2014. The existing partners in Europe are preparing for the commercial launch of the drug in their respective territories. The launch is expected in 2014.
Apricus has entered into partnerships with various companies to market Vitaros. Earlier this month, Apricus entered into a partnership with Laboratoires Majorelle in France, Monaco and Africa. Apricus expects to announce one or more Vitaros related partnerships by year end and expects the rollout of multiple Vitaros launches across Europe in 2014.
As per the information provided by Apricus nearly 150 million patients suffer from ED globally. The ED market, which offers significant commercial potential, currently includes drugs like Viagra, Clialis and Levitra. The incidence of the disease is on the rise. Consequently, successful European launch of Vitaros would boost Apricus’ top line significantly.
Apricus carries a Zacks Rank #2 (Hold). Some better-ranked stocks include Enanta Pharmaceuticals, Inc. (ENTA), Jazz Pharmaceuticals Plc (JAZZ) and Lannett Company, Inc. (LCI). All these stocks carry a Zacks Rank #1 (Strong Buy).