Swiss regulator stalls approval of Apricus Biosciences' Vitaros

2 September 2013

USA-based Apricus Biosciences (Nasdaq: APRI) says that Swissmedic, the Agency for Therapeutic Products in Switzerland, has recommended against approval of marketing authorization for Vitaros (alprostadil) for the treatment of erectile dysfunction based on certain quality related issues.

Vitaros is currently approved in Europe through the European Decentralized Procedure (DPC), with Ireland and the Netherlands last month granting national phase approvals, adding to similar action in Sweden and the UK (August 15), and in Canada as a first line treatment for ED.

In rendering its decision, Swissmedic informed Apricus Bio that the previously submitted preclinical and clinical data were satisfactory and would likely support an approval. However, the Agency also noted that the data provided by the company relating to the targeted shelf life of the product's cold chain formulation was insufficient to support the approvability of Vitaros at this time. The company intends to submit an appeal regarding this decision within 30 days.

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