Boehringer Blows Up Two Drugs In One Trial
19 CommentsBy Ed Silverman // May 16th, 2008 // 11:06 am
File this under How To Sink Your Own Boat. The drugmaker earlier this week released the long-awaited results of a large study involving two of its meds - the Micardis hypertension tablet and the Aggrenox blood thinner - and the outcome may, instead, thin employee ranks and give execs high blood pressure.
The widely touted Profess trial, which was presented at the European Stroke Conference in Nice, France, looked at 20,333 patients in 35 countries. However, according to BI’s rationale, the entire effort was a bust.
First, Aggronex failed to meet its primary endpoint - Plavix, which is far and away the most widely used blood thinner, was superior in secondary stroke prevention. Aggronex, by the way, generated about $400 million in worldwide sales last year.
Another arm looked at whether Micardis, combined with standard antiplatelet therapy, would further reduce the risk of recurrent stroke. The results - 8.7 percent of patients experienced recurrent stroke in the Micardis arm compared with 9.2 percent on placebo. And so, the primary endpoint of superiority couldn’t be statistically confirmed. Micardis global sales in 2007 - about $1.7 billion.
How BI reps will convince docs to use either drug will be an interesting exercise to watch. BI execs, though, are unflappable. “We are proud to have sponsored the Profess study,” Thor Voigt, BI’s senior vp for medicine and regulatory affairs, says in the statement. “We set out to advance the understanding of strategies for recurrent stroke prevention and will continue to evaluate the Profess data to help physicians make more informed treatment decisions.”
Hat tip to Pharmagossip
Nathan
This was a negative trial result. It will obviously hurt their sales. Yet they reported the results anyway. Good for them. We’ve heard too much recently about pharma companies covering up or delaying bad results. Even though the result wasn’t favorable, their behavior stands out to me and I hope to others. Whether heartfelt or not, I love Voigt’s statement about the trial: “We are proud to have sponsored the PRoFESS study. We set out to advance the understanding of strategies for recurrent stroke prevention and will continue…to help physicians make more informed treatment decisions.” Bravo. We need more stories like this. How much money do you think BI lost doing this trial? At least they didn’t loose their reputation in the process.
Dan
Well said, Nathan.
Paul
I agree with Nathan.
An example where kudos are called for.
Insider
Paul, Nathan.
You guys are FUNNY!
You should start a double act.
LOL
Cheers
Bruce
Hi guys,
After ONTARGET and PRoFESS trials failing their endpoints, I think that BI better review their clinical leadership!
I agree it was credible for them to announce their findings, but I would be interested to hear what the sales team will say to the doctors now.
Cheers
Rick
BI is a private company so I don’t think they’ll be too much investor outrage….
Laurie
“I agree it was credible for them to announce their findings, but I would be interested to hear what the sales team will say to the doctors now.”
Couldn’t agree more!
JD
If they were so proud, why was there a ex-US press only through the BI web site release?? After ONTARGET bombed as well with the very positive results from ACCOMPLISH which makes the Generic combo of amlodipine/benezapril the 1st line drug of choice really means that Novartis as well as BI are racing to see who is the biggest loser’s next contestant!
Ed Silverman
Hi Rick,
You’re right. In my mind, I briefly confused BI with that other German drugmaker, Bayer. Both begin with ‘B’ and are based in Germany. Not much of an excuse, but sometimes I move too quickly for my own good. Thanks for setting me straight.
Regards
ed
Bruce
To associate high integrity based upon the fact that they released these awful results is missing the point. That is like comparing two pickpocket artists and saying one is a better person because he did not run from the police when they arrived to arrest him. Seems like its time to come to Daddy for these marketeers. Maybe they can now go somewhere else and sell their version of ’sunshine’to another sucker.
See how many press releases there were for this data versus how they talked it up.
Chris
How else should BI have behaved? They had a very big disppointment, disclosed the results and accepted they are poor and now will have to deal with the consequences. I don’t think this reveals especially great integrity nor does it reflect any wrongdoing on the part of the marketers - I’m not sure where that one came from. I suppose it was handled better than the ENHANCE study though.
pharma PR hack
On Target did show the ACE and ARB substantially the same outcome with the one difference being the lack of flushing with micardis. But did not show an ACE and ARB equal better together versus seperate which might actually be a wake up call to physicians that in most cases poly pharmacy doesn’t equal better.
Granted, the argument has been made that it is the same info as the Valeant trial earlier but that was a hospitalized heart failure patient population versus the typical cardiology patient patient in On Target, Transcend and Profess. Overall, this does not bode well for BI’s growth plans for micardis and definitely doesn’t do any service for aggrenox.
Bruce
Flushing with an Ace? What are you talking about? Hack is about right.
Paging Spin Doctor
You are needed in the PR Dept for a massive German Pharma House
Doc
To say that BI deserves kudos for releasing the ProFess trial results is like saying that the presidential candidates deserve kudos for releasing their tax returns. They had no option. BI has had their sales force pumping this trial for years as the final answer to show Aggrenox is better than Plavix in secondary stroke reduction. They have consistently mislead MDs on the MATCH and CHARISMA trial results, in regard to Plavix. (see their reprint carrier number (07/07) AG46470). Sorry, they deserve no credit, except they did the trial - reporting results was not a magnanomous gesture of open honest data revelation.
HorusCat
Retrospective analysis of various blogs and posts on this site reveals the following:
For most of those on this site, no matter what the drug companies do, they are wrong.
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Jack2
HC, 20% of people will always like you and 20% of people will never like you. This website draws richly from the latter 20%.
Ed Silverman
Hi Jack2,
Actually, the site has a rather large number, and percentage, of readers/viewers from industry and outfits that work with, or support, pharma. I know because I see the subscriber sign-up lists.
However, many people apparently refrain from diving into the discussions here because they worry about their jobs and don’t even wish to use an anonymous sign-on name. I have been told this repeatedly in private conversations.
Consumers who show up presumably don’t have the same constraints, self-imposed or otherwise. And of course, this is the Internet, where anyone can and does show up.
Hopefully, these visits and participation can make for a richer discussion. As a result, though, the impression you may have of the visitors can be a bit skewed, at least depending upon such variables as the topic being discussed.
Cheers
ed
Bruce
I think a picture of the Hindenburg torching would be somehow more appropriate as this is one “fine and upstanding” imperial German Reich. Just a thought. As for the outsiders, this is not such an upstanding company. Those inside know the dirt and the brooms cannot sweep fast enough.
Bruce
Guess the results were bad after all. The news is they are eliminating 50% of their sales force assigned to sell Aggrenox to neurologists! Poof! You’re done.