The most important factor - for the moment deliberately concealed from retail investors - is the broad spectrum of activity of amikacin. The initial Arikace opportunities are actually pneumonia and CF maintenance therapy.
Life-threatening pneumonia caused by TB and Gram-negative infections such as Pseudomonas is a multi-billion dollar opportunity.
This latest proof that Arikace safely delivers an effective concentration of amikacin to a drug-resistant pulmonary NTM infection heralds the end of treating pulmonary infections with antibiotics delivered by tablet or injection.
In the US and Europe alone over a million people each year are hospitalised with pneumonia. 80% of these are caused by Gram-negative infections. 10% currently prove fatal.
From a physician -
[ In the unit - in the hospital - we frequently double coverage people with pseudomonal pneumonia, for example, or gram-negative pneumonia, or just empirically before we know what anything is.
And a patient with a ventilator-associated pneumonia, or just a rip-roaring severe pseudomonal pneumonia, often gets two drugs of a different class ]
[ There's a lot more adverse events when you use two drugs versus one. I think in the end, probably you should use two drugs if someone's really sick, because it improves the chances that you're going to actually have one of them working ]
Is there any real doubt that Arikace will be widely used as an emergency therapy in the US and Europe, in however many of those million-plus cases the physician feels an injected antibiotic could be too late to save the patient?
Looking further afield, pneumonia currently kills around four million people Worldwide each year. How many more manage to survive life-threatening pneumonia?
And proof that inhaled liposome delivery is both safe and effective will support an abbreviated approval pathway for other applications, such as the first-line antibiotics for the eight million Worldwide currently infected with Tuberculosis.