On the BMS call this morning, nothing more was shared on Pargluva, but it seemed clear that the company would seriously consider terminating the program. They noted yesterday in a press release that development may take five more years, clear speculation related to whether the FDA decides they will require outcomes trials associated with Pargluva. Not only would this increase costs substantially for BMS, of course (and Merck, if they are still part of the development, which seems unlikely) but would increase costs for any insulin sensitizer in development where CVD safety is an issue (AZ, LLY).
They did imply (as they had in the release) that the FDA has changed its mind on what data would be required.
This is a win for the cardiologists that brought to the fore the safety questions in the recent JAMA (see prior post on this last week) as well as a win for patients in our view. Looking at the results, although this drug would be "one more option" there doesn't seem anything novel about it, particularly given safety questions.
Its unclear when we'll know more about development, but we wouldn't expect further comment for months and at this point, we would guess development termination is the likely outcome. BMS has a December 12 investor meeting in NY where we may learn more, but sometimes these FDA decisions so drag on that it takes a very long time to learn anything.
In general, the BMS call was negative - they missed earnings and said they anticipate a return to earnings around 2007.
Implications of the BMS news - Amylin effectively has the "new"playing field with Byetta to itself for quite a lot longer, inhaled insulin receives more scrutiny (esp from HCPs), and other companies with insulin sensitizers in development prepare for some difficult conversations.
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The FDA has put off the inhaled insulin decision by 90 days. And no wonder, with everything going on with muraglitizar. Ultimately, we believe that inhaled insulin is approvable, if for no other reason, mainly, that evidence can't really be found to make it NOT approvable. In other words, since most of the safety data appeared to come back clean, and since patients are doing so badly and obviously do need to try new therapies ....
Pfizer did promise it would do a 10-15 year surveillance trial.
Yes, the cost of developing diabetes drugs really increased last week ....