And what is the drugmaker's ceo cautious about? The eye-popping assumptions that Crestor sales will skyrocket, pun intended, now that the widely hyped Jupiter study found that cholesterol pill reduced the risk of cardiovascular death and heart attacks by 44 percent in people with low LDL cholesterol levels compared with patients on a placebo.
"We've seen a flurry of estimates from analysts about the commercial impact of Jupiter, some of them pretty bullish, reflecting a view that there will be a near term, dramatic shift in medical practice," he told journalists on a conference call. "I would urge caution when forecasting the speed of such changes in medical practice."
Why so sobering? Well, the Jupiter study measured a protein called CRP, which is used to gauge arterial inflammation, but there is controversy over its reliability and, consequently, some uncertainty whether docs will rely on CRP. AstraZeneca doesn't yet have FDA approval to promote its pill for people with high CRP. Then, there's the debate over the cost of giving an expensive pill to a wide swath of the population.
"For all the excitement," Brennan says, "we need to remind ourselves that we are only at the starting gate. The full future potential for treating patients with elevated levels of this marker is unclear at this time."
8 Comments
CYA attitude.
Hey Jack -- I agree. But I must say that I do find the AZ CEO's approach refreshing:
"UNDER-promise, then OVER-deliver" as to EPS.
Consider that Schering CEO Hassan has tried to make a career doing the opposite -- he has consistently "over-promised, then UNDER-delivered. . . ."
And lately, he's been willing to blame EVERY UNCONTROLLABLE factor, from currency swings, to an "mean" FDA, to a not-yet-here, but coming Obama Administration. . . .
And yet, he never looks into the mirror -- and REALLY sees himself.
Sees that he is the mirror opposite of AZ, now.
So -- yeah -- I'll take the AZ "under-promising" with a BIG smile. Good to "see" ya' out, and about!
Cheers!
Brennan is a sharp guy. Too bad Merck lost him.
Mr. Brennan's statement that the Jupitor Study was just the starting gate seems at odds with the fact that AstaZeneca is already seeking approval from the FDA for the use of Crestor in patients with elevated CRP levels.
Jim, I don't believe they've filed this with the FDA yet, at least that is the word that I've gotten from other sources. I've heard from a colleague at AHA that they weren't filing until next year, which was surprising to me. I'll search for a source. Here we go: http://www.pharmafeed.com/tag/crestor
Hi Stinky and Jim,
To answer the question, this is also from the Brennan conference:
"From a regulatory perspective we plan to make a submission based on the JUPITER trial sometime in the first half of 2009.
"As with any major new commercial opportunity, we will be able to use 2009 to lay all the appropriate groundwork including consultation with opinion leaders, regulatory agencies and payers. We will also engage with prescribers; specifically to gauge their response to these data in terms of their own practice and attitudes towards prescribing Crestor."
I would post a link, but I don't have one, only the text of his remarks.
Hope this helps, ed
Ed & Stinky
Thanks for the clarification and the links. From the links provided it does appear that AstraZeneca is taking a measured approach. My assumption that AstraZeneca had already filed for FDA approval was based on the statement that "AstraZeneca doesn't yet have FDA approval..." We all know what happens when we assume.
Thanks again.
With statins as a class of medications:
A.E.s are often under-reported with high doses of potent statins in particular. Additionally, there is no reduction in mortality or increase in the lifespan of one on statin therapy.
Several risk factors should determine if one is placed on statin therapy, and not just one.
Statins do decrease CV events and risks significantly. The meds. increase endothelial function, stabilize coronary plaque build up, and decrease thrombus formation. Maximum reduction in LDL is evaluated after about a month of therapy.
There is evidence to suggest that statins have other benefits besides lowering LDL, such as reducing inflammation (CRP), those with dementia or Parkinson's disease, and some forms of Cancer and cataracts.
It appears those statins produced by fermentation, such as Zocor and Pravachol, have less myopathy than the other synthetic statins, possibly due to being more hydrophyllic.
Yet overall, the existing cholesterol lowering recommendation should be re-evaluated, as they may be over-exaggerated.
Address diet in children, who have the arteries of one who is middle age thanks to their diets and recommendations of statins for them.