Inhalation | Combination Therapy | Market Opportunity

There is a real drive to produce multi-component particles whereby two or more respiratory APIs in an exact ratio can be converted to a single particle containing the same drug substances as separate crystalline entities. In combination therapies for asthma and COPD, the APIs often have synergistic action at molecular and cellular level (such as ICS and LABA). However to achieve this they need to be delivered together in exactly the right ratio to their site of action in the lung.

Prosonix has developed its multi-component particle (MCP^TM) technology to produce novel inhaled combination therapies in this way for treating respiratory diseases and has successfully combined APIs within single particles in pre-determined ratios between 1:1 and 1:100. Prosonix has assessed the in vitro delivery of individual components derived from combination particles via carrier based DPI formulations using a range of capsule, blister, reservoir, piezoelectric and disposable devices. In all cases the Fine Particle Dose was consistently higher than when using individual micronized powders and the ratio of the two API's was maintained across all stages of the impactor. They also conferred important benefits with respect to overall particle stability and dose consistency.

MCP^TM technology therefore has the potential to ensure enhanced co-association and co-localisation of drug combinations at the target site and virtually eliminates the variability associated with blending of two or more micronized powders. As a result there is clearly a significant commercial opportunity for Prosonix in the combination respiratory medicines market.

Leading inhaled combination therapies currently marketed include fluticasone/salmeterol (GSK's Advair/Seretide) and budesonide/formoterol (AZ's Symbicort), which together generated sales of $12 billion in 2010. Several other new combination products are also in development.