Allphase Pharma Consulting, LLC
A Professional Service Provider for the Pharma Industry
In the last decade (2000-2010), we saw the number of new antibiotic approvals drop successively each year; FDA changed the rules of the approval process without providing public guidance; many antibiotic companies fled the therapeutic area; investments were redirected to Continue reading The 10 x ’20 Goal – Are We On Track?
VABP is clearly the main indication to be pursued by a drug like POL7080. Here is the question: How to conduct a study demonstrating efficacy for a drug which only has a single-organism spectrum? Which is actually no spectrum at all. Existing Continue reading Polyphor POL7080 And The Journey to The Land of Pyocyanea (Part 3)
Roche’s current Phase 2 program is strangely ambiguous. RG-7929 has not made it into www.clinicaltrials.gov yet, only POL7080 is listed. An uncontrolled open label study in “patients with non-CF acute exacerbation of bronchiectasis due to P. aeruginosa requiring IV treatment” Continue reading Polyphor POL7080 And The Journey to The Land of Pyocyanea (Part 2)
When Roche inlicensed Polyphor’s anti-pseudomonas drug POL7080 in November 2013, it marked a turning point. It seemed that Big Pharma that had all but abandoned the field in the last decade and was getting engaged in anti-infectives again. When a Continue reading Polyphor POL7080 And The Journey to The Land of Pyocyanea (Part 1)
In this day and age, few truly broad spectrum antibiotics are in development, although this does not hold true for narrow-spectrums. Just think of all the MRSA drugs (quinolones, FabI inhibitors), the pseudomonas drugs (NCEs and monoclonals) or some narrow Continue reading Artie’s Law: Avoid Bad Advice and Don’t Follow ‘Mission Impossible’ Advice