Inhaled drug developer Prosonix has announced a global licensing agreement with Mylan for its generic versions of GSK’s Flixotide and Flovent fluticasone propionate MDIs for the treatment of asthma. The deal covers two Prosonix MDIs, PSX1001 and PSX1050, with the same particle engineered formulation of fluticasone; PSX1050 differs from PSX1001 only in having a dose counter.
Prosonix will retain rights to PSX1001 “in certain territories” and plans to file a marketing application in the EU for the product in 2014. Mylan’s marketing rights for both products include North America, the EU, India, Australia, New Zealand, Japan, the Russian Federation and CIS countries, plus several additional European countries.
Prosonix CEO and Co-founder David Hipkiss commented, “Our agreement with Mylan for the global development and commercialisation 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.”
Mylan President Rajiv Malik said, “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.”
Read the Prosonix and Mylan press release.
