Out-licensing

Our proprietary formulation in tablets has the main following marketing claims compared to the main diclofenac based OTC competitor Voltadol marketed by Novartis Consumer Health:

- immediate release profile (Cmax. in 21 min. compared to 29 min.)

- regularity of absorption (reduced standard deviation)

- Cost competitive manufacturing process (dry mixing for direct compression)

The product is been recently approved in Germany (November 2006) and it is about to be launched in this country; APR is currently in the process of starting a MRP in order to extend the German approval in the other EU countries. An EU Standard CTD Dossier is also available for registration of the product in countries outside EU. Finally the product is under final registration in Switzerland.

The patent has been granted in the following countries: Europe, South Africa, New Zealand Australia and Poland.

The Patent is still pending in the following countries: Argentina, Canada, Switzerland, Taiwan and  USA.

Licensing agreements in available countries. In particular APR is interested to evaluate licensing opportunities in countries where the product is approved (Germany) or about to be approved (Switzerland) as well as in all the other countries in Europe (where a MRP is about to start) and outside.