Peddling life cycle management
This article was originally published in Scrip
Executive Summary
In the early days, even before anyone had a name for it, life cycle management was a defensive strategy, an end-of-life rescue therapy in which delivery systems and reformulations gave drugs an extra few years before they were retired to generic pastures. But as Scrip’s new "Lessons in lifecycle management" analysis points out, life cycle management can is now about maximising the health of products throughout their lifetime, and not just about their longevity.
In the early days, even before anyone had a name for it, life cycle management was a defensive strategy, an end-of-life rescue therapy in which delivery systems and reformulations gave drugs an extra few years before they were retired to generic pastures. But as Scrip’s new "Lessons in lifecycle management" analysis points out, life cycle management can is now about maximising the health of products throughout their lifetime, and not just about their longevity.
Don’t know much about history? If you have built up a huge franchise, as Pfizer did with Lipitor, you might want to protect it. But making life extension of your biggest earner to a compound in development is to bet your house on the turn of a card, or on the turn of a cardiovascular candidate, torcetrapib.
Don’t know much biology? The starting point for Merck Bioventures is biologics that have proved their mettle in the market and the strategy is simple: start with (bio)similar, do (bio)better, be (bio)best. We’ll see how that one works out.
Don’t know much geography? Why is it that Erbitux sales in the US have been flat since 2007, whereas in Europe they have nearly doubled? The answer lies in the different patient stratification strategies of US licensee, Bristol-Myers Squibb, and European licensee Merck KGaA. One focused on patients in the KRAS wild-type subgroup in which the drug was more effective: the other didn't.
Don’t know much about ethnopharmacology? Well, who does? And, anyway, it wasn’t in the original song. But for Edarbi, Takeda’s new angiotensin II receptor blocker, and perhaps for GSK/Human Genome’s newly approved lupus antibody, Benlysta, too, working out what works for African-Americans could be important in maximising the franchise opportunities.
But we do know one and one is two. In an increasingly accountable age, executing studies that generate health economic as well as well as clinical data ought to enable companies hurdle reimbursement obstacles, without breaking their stride. But beware! As Lilly found with Effient, cost-effectiveness alone is not enough to dislodge a market incumbent. There will, no doubt, be more lessons in the coming decades. And if industry can learn and apply them, as Sam Cooke concluded "what a wonderful world it would be."