Dipexium gets SME designation in Europe
Dipexium Pharmaceuticals (NASDAQ:DPRX) has been granted small and medium enterprise (SME) designation by the European Medicines Agency (EMA).
The company recently completed its pivotal Phase 3 clinical trials - OneStep-1 and OneStep-2 - with its topical antimicrobial peptide, Locilex, in mild infections of diabetic foot ulcers in the U.S. under a special protocol assessment agreement from FDA.
Dipexium expects to have top-line data from these trials available for release shortly as its scientific advisory team is finalizing the database, which currently remains blinded.
The SME designation was established by EMA to promote innovation and the development of new medicinal products by smaller companies. Companies with SME status are eligible to receive financial incentives as well as administrative and regulatory support through national and regional level programs.
"We are pleased to have SME designation, which allows us to benefit from financial incentives and support from the EMA as we aim to bring Locilex to the global pharmaceutical marketplace," David Luci, president and CEO, said in a statement.
"With prior guidance from the EMA, the results from our clinical trials conducted in the U.S. will form the basis for the planned marketing authorization application to be submitted shortly after filing our NDA amendment with the FDA," he added.