Locally applied and locally acting NSAID Matrix Patch containing 140 mg Diclofenac Sodium

Transdermal system: active ingredient in the patch penetrates through the skin reaching the site of action.

The Swiss R&D company APR Applied Pharma Research s.a. ("APR") and the Italian pharmaceutical company Fidia Farmaceutici S.p.A. ("Fidia") partnered develop and out-license  the Diclofenac Sodium Patch to pharmaceutical companies interested to market this product under their own brand name. APR owns a 50% stake in the project and Fida  owns the remaining 50%.

Diclofeanc Sodium Patch is a matrix patch consisting of 3 distinct layers: the first layer is a transpirant woven  polyester material longwise and crosswise elastic assuring perfect adhesion also when applied on joints like knee or elbow; the second layer is the adhesive layer containing and delivering the active ingredient through the skin and the third layer is the protective release liner to be removed prior application.

The Diclofenac Sodium Patch has the following advantages compared with the existing topical medicated plasters:

a) Very good adhesive properties

b) Longer and more constant drug flux through the skin

c) No clothes contamination during treatment

d) Fixed dressing especially for joints

The product has been developed according to the "Note for Guidance on the Clinical requirements for locally applied, locally acting products containing known ingredients" (CPMP/EWP/293/95 dated June 96).

Preclinical studies have been all successfully completed to assess safety and tolerability of the product. 

PK studies comparing our Diclofenac Matrix Patch vs. marketed diclofenac plasters are successfully completed.

The Product is registered and marketed in Italy since early 2005.

Europe

Three pivotal Phase III clinical trials ready to start in Europe; after the completion of these studies, The filing for Marketing Application in Europe is expected by 2Q 2010 and will most probably, be a Decentralized Procedure starting from France as RMS;

 

US

Opened an IND in US to start with the completion of the development with the clinical part in order to submit a 505(b)(2) application. The dossier for the 505(b)(2) application is expected to become available by 2Q 2010.

 

Registered

Patent on product and process pending and under PCT procedure.

As of January 2009, 140mg Diclofenac Na matrix patch is available/not available for licensing in the following countries:

 

Region	Comment
Europe	Already Licensed in France, Italy, Belgium, Luxembourg Greece and Switzerland, available in the other countries
US & Canada	Available
Russia and former CIS countries	Already Licensed in Russia, available in former CIS countries
Central America	Avaliable
South America	Available
MEA	Available only for Non Exclusive Licenses in Algeria, Tunisia, Morocco, Benin, Burkina Faso, Niger, Togo, Congo, Gabon, Cameroon, Mauritania, Ivory Coast, Mali, Guinea, Senegal, Chad, RCA, Madagascar, Djibouti, Nigeria, Ghana, Zaire. available in other countries
Asia	Available
Oceania	Available