From The Most Recent Amgen Earnings Conference Call:
Mark Schoenebaum - ISI Group:
It’s a question for Sean, if I may. Sean, can you give us an update on the cardiac myosin activator? What data has Amgen actually produced for that drug? Where is it precisely in clinical development? When can investors expect some more disclosure about it? And what are next steps? And also, I’d be curious, in general, what’s your level of confidence in this program. I know heart failure is in general risky, but I’d love to just take your temperature on your thoughts? I realize at the analyst meeting we’ll have a lot of time to go through this.
Sean Harper - Amgen EVP of Research & Development:
Certainly the program, which we call AMG-423, is a very interesting program from a scientific perspective. It represents one of the only novel mechanistic basis for addressing systolic heart failure, which is, I’m sure, you recognize is an epidemic disease with older demographics.
I think that we’re still at an early stage with the program. We have recently completed a third cohort in a Phase IIA IV based study that was designed to assess safety of the product versus placebo as well as some efficacy parameters to look to see if when we tightly control exposure with the molecule, we can actually determine that there is a therapeutic window for the mechanism.
Beyond that, we’ve started now into an oral dosing study to see if we can achieve, in heart failure patients, a well-behaved oral formulation, PK exposure profile, because again therapeutic window is going to be key here. So it’s early.
This is a difficult area. I would characterize this as, on the spectrum of what we’re doing, on the sort of high risk-high reward quadrant. But I think the opportunity to benefit very large numbers of patients with the very grievous illness warrants the risk profile. So I find the program extremely interesting, but it’s still at a pretty early stage of development.
The morons on this board are pumping this and they're so stupid they don't even realize the results being published in August/September are primarily safety numbers. Efficacy numbers are scarce in this Phase IIb. They could barely get the drug into the patient at the proper time in the IV format to judge efficacy. There's a narrow therapeutic window with this drug which is the reason they will ultimately be forced to abandon the IV format.
Ozzie: The Market often buys the sizzle, not the steak. There are dozens of instances of a stock such as RIGL being manipulated up in price on early-stage trials. Buy NOW and you won't have to chase later.
FDA has opened doors for new expedited regulatory pathway to allow FDA approval of drugs based on phase2 studies, or a singular phase 3 study without multiple phase3 trials necessary for approval.
This drug might' have a shot for expedited approval due to the severity of the illness.and then any necessary agreed upon post approval studies can be done..