1. To get Arikace approved for CF/Pa in Europe and Canada based upon the data generated among those countries. This should be achievable because Arikace showed equivalency among the already approved inhalation antibiotics (TOBI, TIP, azithromycin, cayston, etc.) and the medical literature says physicians need choices to switch antibiotics when resistant strains of Pa infect a person.
2. Hopefully parlay the same information into a regulatory stance in the US FDA that CF/Pa patients should have the same treatment options as Europe and Canada.
3. Get approvals for Japan, Australia/New Zealand and South Africa and other countries to include those CF/Pa patients.
4. Identify any other orphan/niche markets that a Phase IV clinical trial might identify for Arikace (this will probably not include pneumonia or TB for obvious reasons).
The INSM R&D Agenda:
1. Find other drugs for pulmonary conditions that are biocompatible with the liposome. The basis of the research should be to develop at least two generic inhalational drugs and identify four novel, proprietary drugs that might be accomplished through a partnership. If INSM gets one or two potential partnerships going, the path to an independent the future in the biopharma business will become more probable.
rehdvm2004 • Aug 1, 2013 7:55 AM Flag
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I would add that INSM has a trump card in the additional $58 million that they will or can raise on a moment's notice. That is a strong position. Lets hear what WL says next Tuesday.
"To get Arikace approved for CF/Pa in Europe and Canada based upon the data generated among those countries. This should be achievable because Arikace showed equivalency among the already approved inhalation antibiotics (TOBI, TIP, azithromycin, cayston, etc.) and the medical literature says physicians need choices to switch antibiotics when resistant strains of Pa infect a person."
The reason you completely overlook the most important factor here is that you are a VET - pretending to be knowledgeable about the treatment of infection in humans.
Animals don't have compliance issues, whereas humans often do.
Poor compliance allows greater opportunity for drug-resistant strains of bacteria to evolve. Antimicrobial resistance is viewed as a potentially catastrophic threat to public health by medical and regulatory authorities worldwide. Do some research on CRE.
Because you're not aware of this you don't understand that Arikace is the answer to their prayers.
Where humans are concerned, once-daily dosing is expected to lead to far greater compliance with the therapeutic regimen.
An even more important factor is that an inhaled antibiotic will eradicate a pulmonary infection far more quickly than an antibiotic administered either by tablet or by injection - also significantly reducing the opportunity for drug-resistant strains to evolve.
It's to your credit that you try to contribute to the discussion. But you need to be a little more aware of your limitations, because your posts are embarrassing at times.
If you want to know what's really going on here ask yourself this question -
How likely is it that either the FDA or the EMEA will NOT approve Arikace for the treatment of every pulmonary infection for which amikacin injection is routinely used?