Out-licensing

The application of APR patented Immediate Release Technology to a formulation in granular powder of Potassium Diclofenac 50mg. resulted in a product with unique properties in the therapy of Migraine, demonstrated by specific Phase III Clinical trials, absolutely outstanding compared to other NSAID’s product for Migraine and equivalent to oral Triptan products. 

APR Fastest for Migraine may be considered the election 1^st line therapy in migraine attacks (also Severe) since:

• Is as effective but faster than Triptans
• Is as safe but faster and more effective than NSAIDs
• Shows a lower pain recurrency than triptans
• Allows a sustained pain free
• Is cheaper than triptans

While specific clinical studies demonstrated, already in 1999, the substantial equivalence of 50mg Potassium Diclofenac and 100mg Sumatriptan in Migraine treatments (cfr Drugs 1999 Jun; 57(6):991-1003 McNeely W, Goa KL), recent Phase III clinical studies made on APR fastest for Migraine demonstrated the greater superiority of this IRT based formulation towards other Potassium Diclofenac in the treatment of Migraine.A summary of these results:

• APR Fastest for Migraine was superior to diclofenac-K tablets in % of patients pain-free at 2 hours post-dose
• APR Fastest for Migraine showed a faster onset of pain relief than diclofenac-K tablets (15 min vs. 60 min)
• APR Fastest for Migraine were superior to diclofenac-K tablets in pain relief up to 2 hours post-dose and similarly effective throughout the 8 hour observation period
• APR Fastest for Migraine and tablets were more effective than placebo in reducing accompanying symptoms
• APR Fastest for Migraine were more effective than tablets in reducing nausea and photophobia in the first 2 hours
• Both APR Fastest for Migraine and tablets were well-tolerated. There were no SAEs reported.

The patent has been granted in the following countries: Europe, USA, Switzerland, Taiwan, South Africa, New Zealand, Australia and Poland. The Patent is still pending in the following countries: Argentina, Canada

In February 2003 APR entered an exclusive license agreement with Novartis Pharma AG in Basel for several countries: 

APR Fastest for Migraine is already registered and ready for launch in: Germany, Sweden, Denmark, Norway, Finland, Ireland, Portugal, Ukraine, Brasil  and certain other non European countries

 APR Fastest for Migraine is available for registration and licensing in several other EU and non EU countries including:United Kingdom, France, Austria