PSX1001/1050 is licensed to Mylan Inc., one of the world’s leading global pharmaceutical companies, for development and commercialisation in designated territories1, with Prosonix retaining rights in certain EU territories, China, South America, the Middle East and Africa.
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).
PSX1001, with the addition of a dose counter on the pMDI device, is under development for the US market as PSX1050.
Flixotide®/Flovent® pMDIs generated global sales of approximately $930 million in 2014.2 Because of the innate complex formulation challenges, this represents a major commercial opportunity for Prosonix.
1US, Canada, Australia, New Zealand, India, Japan, the EU, Iceland, Liechtenstein, Norway, Switzerland, Turkey, Russian Federation and the Commonwealth of Independent States
2Originator sales estimates based on GSK Annual Reports 2011 and 2014 and selected IMS data 2011 and 2012
Flixotide®/Flovent® are trademarks of the GlaxoSmithKline group of companies