Apricus Biosciences, Inc. (APRI) recently announced that its erectile dysfunction (ED) drug, Vitaros, has been approved under the European Decentralized Procedure (DCP).
Apricus, along with its commercialization partners, Sandoz, Takeda Pharmaceutical (TKPYY) and Bracco, will now look to obtain national phase approvals to make Vitaros available in all territories across Europe.
Results from a phase III study evaluating the safety and efficacy of Vitaros and its long-term use in men who did not respond to phosphodiesterase type 5 (PDE-5) inhibitors like Viagra (n=325) showed that multiple doses of Vitaros (200 mcg and 300 mcg) improved erections in patients.
Apricus’ marketing approval application for Vitaros designated 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) who participated in the procedure.
Although Apricus believes that Vitaros has the potential to capture a good share of the PDE-5 inhibitor market (worth approximately $1 billion) once launched, we note that the market currently has big companies like Eli Lilly and Company (LLY).
The company also mentioned that it will continue to seek additional partnership agreements for Vitaros in the rest of the European and global markets.
Apricus was recently engaged in a $17.1 million financing. It also divested multiple non-core assets and has also streamlined its global operations. This should allow the company to focus on its lead assets for male and female sexual health, namely, Vitaros and Femprox.
Apricus presently carries a Zacks Rank #4 (Sell). Currently, companies like Jazz Pharmaceuticals (JAZZ) look more attractive with a Zacks Rank #1 (Strong Buy).
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