PSX1001 is licensed to Mylan Inc., one of the world’s leading global pharmaceutical companies, for development and commercialisation in designated territories outside the USA.1
In September 2014, Prosonix announced that its Marketing Authorisation Application (MAA) for PSX1001 had been validated and was being assessed under the Decentralised Procedure (DCP), in which the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) is the Reference Member State. Prosonix is developing PSX1001 in the EU under regulatory guidelines that allow the approval of generic inhaled products by in vitro equivalence (IVE) alone (CPMP/EWP/4151/00 Rev. 1).
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 pMDI devices.
PSX1001, with the addition of a dose counter on the pMDI device, is under development for the US market as PSX1050 and is targeting Abbreviated New Drug Application (ANDA) submission.
Flixotide®/Flovent® generated global sales of nearly £800 million (more than $1.3 billion) in 2013.2 Because of the innate complex formulation challenges, this represents a major commercial opportunity for Prosonix.
1Canada, Australia, New Zealand, India, Japan, the EU, Iceland, Liechtenstein, Norway, Switzerland, Turkey, Russian Federation and the Commonwealth of Independent States
2GSK Annual Report 2013
Flixotide®/Flovent® are trademarks of the GlaxoSmithKline group of companies