Garnier: Here Comes The ‘Progressive Blockbuster’
6 CommentsBy Ed Silverman // February 16th, 2008 // 8:10 am
As he heads towards the exit door at Glaxo, JP Garnier stopped to chat with The In Vivo Blog about the issues confronting the troubled drugmaker, and pharma, in general. Given that safety is a hot-button issue and researchers have plucked much of the low-hanging fruit, Garnier believes a new mini-model is about to emerge….
“The development of new chemical entities and new biologicals is going to change. One way is to slice the patient populations, not to try to put the drug on the market for all the patients that could benefit, but focus on the easiest slice, the ones where they would be the least amount of controversy from a safety efficacy standpoint.”
Then you “get the drug on the market because there you will have…an easier file for the FDA to react to.” And “then build up your product as you would an oncology drug” by adding more and more slices of the potential patient population. “By that time you have developed a lot of knowledge about your drug anyway, so it becomes easier to do the right development.”
“You are not going to get instant blockbuster with this kind of technique, you are going to get progressive blockbusters.”
Laurie
“but focus on the easiest slice, the ones where they would be the least amount of controversy from a safety efficacy standpoint.”
How sad is this statement. It’s not about true safety/efficacy, it’s about avoiding controversy.
Matthew Holford
Jesus! This guy Garnier’s a huckster!
This sounds very much like: target a patient group that won’t give us much in the way of adverse reactions (cherry picking), get the drug on the market, before selectively adding further patient groups, by getting a drug licensed for additional indications (whilst simultaneously suppressing negative data, no doubt).
That doesn’t sound so very much different from the current model - the wording’s just slightly different.
Matt
ol cranky
This is the latest model in development for arthritis: you intentionally conduct development limited to severe large joint arthritis in the hopes of being able to delay the need for joint replacement surgery (an “unmet” need). This allows you to submit with a much smaller safety database shaving off years from the development cycle. You broaden the indication after the drug is approved in the narrower indication knowing it will be used off label for arthritis regardless of severity (the off label sales pay for the sNDA program and, since it’s really easy to hide off label promotion in this massive indication, you’re not stressed about timelines).
Colorado Kid
JP is just like Montey Burns (looks like him too), and has the same ethical back bone (or lack there of). Will he ever produce the 9 missing pages Sen. Grassley asked for? JP took one mediocre company and one great company and ran them both into the ground!
Melody
Too bad that most of these companies actually have competition. Otherwise, the model Mr. Garnier is proposing has already been shown to work well. When Lilly developed rDNA human insulin, it filled a niche market–aimed at those who were allergic to beef and/or pork insulin. But because Lilly dominated the U.S. market, and to all appearances had ‘an understanding’ with Novo, all they had to do to attain “blockbuster” numbers was . . . remove their other, older, non-patented products from the marketplace.
At the time, only a small ’slice’ of the diabetic population had a ‘need’ for so-called human insulin. Today, there is a similar small slice that has a real, urgent need for natural (animal-sourced) insulin. Sadly, business decisions by the insulin cartel have provided no recourse for this small ’slice.’ C’est la vie. . . profits before patients.
Skeptical
I wonder which senior partner from McKinsey or whatever wrote those words. “It’s the Orphan Drug development model, stupid.”
Sadly, the sorry state of affairs the industry is in is due to the the fact that CEOs and other senior leaders are de facto employees of these consulting firms. As far as marketing abuses senior commercial people follow blindly the directions of Madison Avenue Ad agencies, or as they like to be called now, communications agencies.