Thursday, July 21, 2011

Novartis and Antibiotics - On the Edge

NOVARTIS HAS RETURNED THE RIGHTS TO AMADACYCLINE BACK TO PARATEK PHARMACEUTICALS!! This was correctly predicted by a Pharmawire article back in June (the link requires a subscription – sorry).   At the time, this news was news to Paratek. But in Novartis 2nd Q Report they note in a single sentence that clinical development on the compound had been discontinued (go to link – search for PTK).   As I noted during my discussions with Pharmawire back in June, I have strong reason to believe that this was in large part motivated by Novartis’ inability to secure agreement from the FDA on a feasible trial design for community-acquired pneumonia in the US.  Amadacycline is a perfectly good drug for skin infections and pneumonia.  Their phase II study of skin infections was well done and the drug performed well compared to linezolid – always a good sign.  I think that the inability of Novartis to capture this important US market segment was dissuasive to their commercial group. 

At the same time, they have reorganized their clinical development group and one of their most senior infectious diseases clinicians was “retired.” I remember back 10 years ago when I would give talks about the abandonment of antibiotics by large pharma, two companies used to rise to talk about their commitment to the area – Glaxo and Novartis.  The physician from Novartis who was their most vocal spokesperson is the one who was “retired.” 

They still have an antibiotics discovery group that is in the process of moving from Boston to Emeryville, California and rebuilding.  But if their commercial people were dissuaded by amadacycline, what do they currently think about their internal program?  Will they continue to invest internally in antibiotic research?  Will they continue to seek new antibiotic opportunities externally?  Although these questions remain unanswered, I have suspected for some time that they would be bowing out of the field altogether.

If Novartis should take this last and final step to back out of antibiotics altogether, I think we can lay much of the blame at the feet of FDA and their continuing inability to provide feasible ways forward for the development of antibiotics in commercially important indications such as community-acquired pneumonia and others.

Comments are welcome.

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