Prosonix has announced that it has entered into a global licensing agreement with Mylan Inc. for its leading inhaled respiratory products, PSX1001 and PSX1050.
PSX1001 and PSX1050, which are the first products to emerge from Prosonix’s innovative and proprietary particle engineering platform, are being developed as generic versions to GlaxoSmithKline’s pressurized metered dose inhalers (pMDI) 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 ending Dec. 31, 2013. A first marketing authorization application for PSX1001 is expected to be submitted in the European Union in 2014.
David Hipkiss, CEO and Co-founder of Prosonix, said: “Our agreement with Mylan for the global development and commercialization of PSX1001 and PSX1050 is a major milestone that reflects the outstanding contribution of the whole Prosonix team. As a world leader in manufacturing and commercializing high-value, difficult-to-manufacture generics and with a growing respiratory franchise, we believe Mylan is the ideal partner to ensure PSX1001 and PSX1050 are a commercial success and a strong validation of our ‘Respiratory Medicine by Design’ philosophy.”
Rajiv Malik, President of Mylan, commented: “We are very excited to enter into this agreement with Prosonix as it represents another development milestone in our global respiratory franchise, one of our key strategic growth drivers, and strengthens our portfolio of difficult to develop and manufacture products. Further, Prosonix’s expertise in the development of inhaled respiratory products perfectly complements the strength of Mylan’s respiratory R&D capabilities. We look forward to a successful collaboration with Prosonix in the coming years as we bring to market generic versions of Flixotide and Flovent around the world.”
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.