Mylan gains U.S., Canada rights to proposed generic equivalents of Flixotide and Flovent

OXFORD, England  — Prosonix, a speciality pharmaceutical company developing a portfolio of inhaled respiratory medicines by Design, on Tuesday announced that it has entered into a global licensing agreement with Mylan for its leading inhaled respiratory products, PSX1001 and PSX1050.

PSX1001 and PSX1050, which are the first products to emerge from Prosonix's proprietary particle engineering platform, are being developed as generic versions to GlaxoSmithKline's pressurised metered dose inhalers Flixotide and Flovent, respectively. Flixotide and Flovent contain the active ingredient fluticasone propionate, a potent inhaled corticosteroid, and are indicated for the treatment of asthma. 

According to IMS Health, Flixotide and Flovent had global brand sales of approximately $1.3 billion for the 12 months ended Dec. 31, 2013. A first marketing authorisation application for PSX1001 is expected to be submitted in the European Union in 2014.

Under the terms of the licensing agreement, Prosonix will file PSX1001 in the EU and retain marketing rights in certain territories. Mylan has marketing rights for PSX1001 and PSX1050 in the U.S., Canada, Australia, New Zealand, India, Japan, the EU, Iceland, Liechtenstein, Norway, Switzerland, Turkey, Russian Federation and the Commonwealth of Independent States. All other terms of the agreement remain confidential.