Out-licensing

Registered in one EU country and an updated CTD Dossier is available for application in other countries. The product has been already licensed out exclusively for Italy to a major undisclosed swiss based multinational company. This product has been developed using a sugar free, mint flavoured formulation and using a very low cost manufacturing process (dry mixing for direct filling and packaging) enabling licensees to have enough margin for a successful promotion.

This formulation has been developed for the OTC market. In fact, provided that:

a) Diclofenac Na is the only Diclofenac Salt that can be switched from the RX to the OTC because it is the only salt for which enough safety and pharmacovigilance data are available to justify the switch

b) 25mg Diclofenac Na tablet is already OTC in one EEC country (Italy) for more than 10 years The most promising marketing opportunity is: 1) RX to OTC switch strategy 2) Brand Strategy in the OTC field The requirements to be succesful in the OTC field are: 1. FAST ACTING PRODUCTS to claim real analgesic activity without major GI side effects 2. To have a line of products to build a BRAND STRATEGY 3. To have PATENTED PRODUCTS to avoid competitors APR's Diclofenac based formulations answer them all.

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.

License agreements in the remaining countries available.