The API, fluticasone, is made at Sterling’s plant in Italy and is optimised for use in respiratory drugs by Prosonix’ engineering tech which, unlike jet milling processes, gives precise control of particle size, shape and crystallinity.
The compound is already being used by Sterling’s clients in a number developmental-stage and commercially available MDIs, DPIs and intranasal presentations. Prosonix CEO David Hipkiss told in-Pharmatechnologist that these include both originator and generic companies, but could not provide further information.
He also said that the API is being used by Prosonix in its own development programmes but, again, declined to give any further details.
Surety of supply
Hipkiss went on to describe the collaboration with Sterling, Europe’s leading independent steroid manufacturer, and the successful commercialisation of as a key achievement for both firms.
“Sterling gives supply security and access to a large pool of potential customers” he explained, adding that, in terms of MDI inhalers alone, the partnership gives access to a market worth around $300m a year.
Hipkiss added that: “This is yet another milestone for Prosonix, delivering further confidence in our ability to commercialise our proprietary technology in support of our key focus in high value respiratory product development.”
This was echoed by Sterling CEO Simone Ferlin who said in a press statement that the partnership provides “clients with the surety and quality of steroids that delivers the optimum solution for complex respiratory challenges.”
Technology licensing
Hipkiss also stressed the importance of a close relationship with Sterling as a key part of Prosonix strategy.
He said that, although there is flexibility, “We do not plan to license our technology widely,” adding that controlling access to Prosonix’ ‘game changing’ particle engineering IP through such deals is vital.