Replies to post #116268 on Biotech Values

[tinkershaw]

1.3-1.7 average A1C reduction is consistent across the board with the extended release version of the drug. What bydureon is stuck with at present is that we are probably about the same as Victoza, but only one stick a week, vs. We are better and only one stick a week (that was the monster blockbuster).

Still, if you own MNTA, bydureon is the same drug as byetta. Just a different dosing and release process. Hmmmm, is that not what Teva just tried with low volume copaxone that Teva insists is so material to MNTA's copaxone application and the need for clinical trials?

Just an example at out finger tips demonstrating that same formulation, different delivery methodology does not equal the same drug to the FDA.

Tinker
Update: I take back the "we are probably abou the same" as this quote from the AP story:

The companies said earlier this month that Bydureon proved inferior to Novo Nordisk's Victoza, according to initial results from a late-stage study comparing the drugs. The companies said Bydureon reduced average blood sugar levels in type 2 diabetes patients

by a smaller amount from a baseline measurement than Victoza

Talk about a marketing killer. Is "inferior" to its competitor. That one hurts. I sold my AMLN prior to the second CRL and was fortunate to do so. It was a nice triple. I have followed AMLN for 2-3 years, and for the life of me stating that bydureon is inferior to Victoza was unimaginable until last week. Bydureon still has the extended release benefits, but not in my wildest dreams was inferior ever a possibility.