Prosonix has submitted an MAA for its PSX1001 fluticasone propionate MDI for the treatment of asthma, triggering a milestone payment from Mylan, the company has announced. In April 2014, Mylan acquired marketing rights for PSX1001 and another FP inhaler, PSX1050, in most of Europe, North America, Japan, Australia, India, and a number of other countries.
PSX1050 includes the same particle engineered formulation of FP as PSX1001 but has a dose counter. The two products are generic equivalents of GSK’s Flovent and Flixotide.
Prosonix CEO and Co-Founder David Hipkiss commented, “The achievement of this key milestone is a landmark event for Prosonix. Our MAA for PSX1001 is the first of our product pipeline to be reviewed under the EU regulatory guidelines that allow the potential approval of generic inhaled products based on in vitro data alone. We are excited to be able to use this regulatory approach to deliver our strategy, consistent with the new Global Initiative for Asthma (GINA) management and prescribing guidelines which we believe are set to dominate the reimbursement and payer agenda for the foreseeable future.”
Read the Prosonix press release.
