FDA grants ODD for the use of teicoplanin in Staphylococcus aureus infections in cystic fibrosis patients

RP announcement

Milan, July 10th 2018 Neupharma and Rare Partners announce that they received from FDA on May 24th the granting of Orphan Drug Designation for the use of teicoplanin in the treatment of Staphylococcus aureus infections in cystic fibrosis patients.

The designation obtained in USA follows an analogue decision taken by the European agengy EMA on August 23rd 2017.

The Italian biotech Neupharma and the non profit company Rare Partners, both active in the field of rare diseases, have developed an innovative inhalable formulation of teicoplanin that could start the first clinical trial before the end of 2018.

Fabio Borella, President and co- founder of Neupharma, said: “Pulmonary infections caused by resistant germs and in particular by Methicillin resistant Staphylococcus aureus (MRSA) are a relevant emergengy in patients affected by cystic fibrosis. The granting of orphan drug designation both in Europe and USA in this rare therapeutic indication confirms the great interest for an inhaled formulation of teicoplanin. Neupharma is leader in Italy in the field of inhalatory treatments, thanks to its partnership with major international players. This project will allow Neupharma to have its own product in the two major markets, EU and USA”.

Marco Prosdocimi, Managing Director of Rare Partners, said: "We are extremely satisfied with the collaboration established in recent years with Neupharma, a company that is a reference point in our country for doctors and at the forefront in the treatment of respiratory infections, cystic fibrosis in particular. The two designations obtained for inhaled teicoplanin in Europe and USA represent an important milestone that confirms the potential value of this innovative project”.

About Neupharma

Neupharma is a young and modern company focused on innovation aiming at rare diseases, particularly cystic fibrosis. Neupharma is market leader in Italy for the inhaled treatment of chronic Pseudomonas aeruginosa lung infections. Neupharma distributes in Italy  the most advanced medical devices for the inhalation therapy in cooperation with the world leader Pari GmbH.