Prosonix is developing PSX1001 in the EU under regulatory guidelines that allow the approval of generic inhaled products by in vitro equivalence (IVE) alone and is targeting its first submission for marketing approval in 2014.
Prosonix has undertaken an extensive programme of API and formulation development for PSX1001. Production has been tested at commercial scale, with PSX1001 demonstrating in vitro equivalence to the currently marketed material in both pMDI and DPI formulations delivered through existing simple, cost-effective devices.
PSX1001, with the addition of a dose counter on the pMDI device, is under development for the US market as PSX1050. Prosonix is in discussions with the FDA over the optimal development strategy for PSX1050, which is expected to be via the Abbreviated New Drug Application (ANDA) route.
FP monotherapies are the world’s most prescribed ICS for asthma and accounted for more than 40% of the >$2 billion ICS sales in 2012. According to Datamonitor*, ICS sales will stay at this level through 2021 in the seven major markets (USA, UK, Germany, France, Italy, Spain and Japan).
No directly substitutable generic drug product is yet sold in the major markets despite the expiry or imminent expiry of the key patents, because of the innate complex formulation challenges, and this therefore represents a major commercial opportunity for Prosonix.
*Datamonitor Reference Code: HC00219-004 Publication Date: September 2012