Prosonix has developed PSX1002 as a drug-only pMDI suspension formulation. A Phase 2a clinical study in patients diagnosed with moderate-to-severe COPD has been completed, with positive top-line results reported in January 2014.
The randomised, double-blind, single-dose study met its primary endpoint of demonstrating that PSX1002 improved lung function in COPD patients for a range of doses of PSX1002, compared to placebo. Good tolerability and safety profiles were observed for all doses of PSX1002 investigated.
The positive results of the study have enabled Prosonix to identify two doses and a primary dosing interval (i.e. ‘once daily) to investigate in a subsequent repeat-dose, dose-ranging study.
PSX1002 requires no extraneous carrier materials or excipients and is straightforward to manufacture. Because of its engineered heritage, the product does not have the need for any ‘cold chain supply,’ and hence can be delivered from through simple pMDI multi-dose devices, thereby presenting an opportunity to maximise its commercial potential in developed and emerging economies. A capsule-based DPI presentation is also being considered.
Prosonix’ engineered GB also underpins its PSX2000 MCP™ programmes for novel combination respiratory therapies, in which it is combined with known LABA and ICS molecules in proprietary MCP™ formulations.
Glycopyrronium bromide is the active component in Novartis’ Seebri® Breezhaler®, a DPI formulation for COPD which was approved in Japan and in the EU in 2012 and is now also approved in several other countries. Novartis reported global sales of $58 million for 2013 following its launch1, with analyst expectations of peak sales reaching $400 million per year. According the World Health Organization2, approximately 65 million people worldwide had COPD in 2004 and it is predicted to become the third leading cause of death by 2020. A limited number of mono and combination therapies are approved for this indication and together these products generated sales of more than $8 billion in 2011 in the seven major markets. LAMAs accounted for approximately $3 billion in sales from this total and Datamonitor3 estimates that sales of this class of product will remain stable through 2020. In addition, a cDPI mono-dose format of GB was approved in the EU and in Japan in 2012, with analyst estimates for annual sales in these markets of up to $1 billion. Estimates vary for the growth of the global market for COPD therapies, with Decision Resources4 anticipating it to grow 4.6% per annum exceeding $13 billion in annual sales in 2019. Significant product opportunities exist for drug-only formulations in pMDI or DPI, and novel dual and triple combination therapies.
1Novartis Annual Report 2013
2The Global Burden of Disease: 2004 update, 2008
3Datamonitor COPD November2011 HC000218
4Decision Resources, Chronic Obstructive Pulmonary Disease, 2007
Seebri® and Breezhaler® are registered trademarks of Novartis