RE: Reminder21 Aug 2018 23:10
Some excellent contributions over the weekend. Many thanks all. Hope you managed some time off for a beer/glass of wine unless you were drinking on the job!! Some comments
Firstly, Ivy, thanks for the link to the Dr O’Riordan video. A positive endorsement. I’ve done some digging and he, along with many other highly regarded medics in the microbiology space, have co-authored papers on the Iclaprim trial results with David Huang. Most of these individuals are US based but two in the UK. They all appear to be associated with highly regarded institutions, such as Duke University, and going by their CVs in influential positions. For example, the UK contributors include Prof Mark Wilcox who advises the NHS on antimicrobial resistance. Their endorsement of Iclaprim will undoubtedly be extremely important come approval and commercialisation.
Totally agree Ivy with your list of reasons why FDA approval is now a distinct possibility. However, one concern that I have had which unfortunately has been reinforced by Laggan and Stebol and then Staggart yesterday and that is the scale of the commercial opportunity. The potential US market, as referenced in MTFB presentations, is substantial but the actual addressable market will be much smaller, but I can’t quantify. What is fueling my concern is the increasing cost pressures the provision of healthcare, public and private, is under in the West. Drug costs are an important consideration and an easy one to reduce particularly with the pressure being applied through the media on the pharma sector. How does that affect the commercial opportunity for Iclaprim?
The current SoC for the treatment of gram-positive infections is Vancomycin. Whilst Iclaprim has been proven to be safer and more efficacious, Vancomycin is well established and, thanks to multiple generics, cheap. Iclaprim cannot and should not compete on a price basis. I may need correcting on this, but I believe that in large medical institutions there will be a purchasing department responsible for sourcing drugs and measured on short term budget considerations and cost savings and, despite possible pressure from medical colleagues, will look primarily at the price tag……….1st choice Vancomycin. To be successful commercially, MTFB and partner/s must be going to market with a detailed cost/benefit analysis that factors in the many other benefits of Iclaprim that we are aware of. Full circle back to my opening para, the nurturing and endorsements of these heavy weight and influential doctors will have a significant bearing on the success of Iclaprim and I will be watching for any further articles and/or public pronouncements coming from them supporting Iclaprim.
Apologies for the length of this but concerned not about the short-term approval cycle but the longer-term commercial implications. Appreciate any feedback that will allay these concerns. I’m sure I’m not the only one!!