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to be less significant that I hoped they’d be. Like many in 2001, I was persuaded that by blocking signal transduction pathways in tumor cells, we’d have a dramatic effect on tumor progression and survival. Despite an enormous amount of work at Amgen and other companies, the output has been modest. While we registered an important drug, which is efficacious in a number of patients, we failed in a number of areas.
On Vectibix, Amgen’s first anti-tumor medicine for colorectal cancer, which fell short of expectations:
Vectibix is a good drug for a small number of people, and is not nearly as effective as it should have been. It was a disappointment for me.
On why the time and expense of drug development keeps getting worse:
There’s no doubt it is harder now to register new (FDA-approved) drugs than it was a couple decades ago when I started. It’s harder for a number of reasons. There’s less room for new drugs. Generic penetration has had a pretty big effect on the impact of new pharmaceuticals. It’s impossible to bring forward a new drug that offers modest improvement when you’re competing with generics that cost pennies a day.
Not inappropriately, we’ve raised the bar dramatically on what we expect from new drugs. They have to have a clearly better benefit/risk profile. The FDA now wants to see more long-term outcome studies. That raises the expense of development substantially, when you’re talking about larger clinical trials.
On the other hand, I’d say the productivity of the biopharma research community, while declining, isn’t declining in the same way for all organizations. Matt Herper at Forbes, in what I think he’d say was a pretty simple but useful analysis, looked at the total spending on R&D, the number of drugs registered at major companies, and the amount of R&D spending per registered drug. Amgen was most productive, and AstraZeneca was the worst. And there was a big range from top to bottom. My view of this is that yes, it’s more expensive, and yes, it’s harder than ever before, and the only way to success is to eschew distraction. It’s so hard to do, to focus only on things that can make a real difference.
On which pipeline program investors should watch at Amgen:
One that is getting a lot of attention is AMG145, which is a PCSK9-targeted therapy for cholesterol reduction. We described recently that we are seeing quite dramatic lowering of LDL cholesterol in patients who are unable to get to their goal with statins. There are millions of patients who could benefit from a drug like this.
This drug is interesting for another reason as well. When I came to Amgen, it wasn’t my goal to bring biotech to primary care. What we succeeded in doing here, through improved efficiencies, we ended up building a biotech organization that’s comfortable bringing biotech products to a primary care environment. You have denosumab in osteoporosis, which is a primary care indication. Look at how well it’s doing. AMG145 could do a similar thing. It may just be a natural evolution, in terms of how companies evolve. It took a lot of hard work, to get manufacturing to work at that scale, and clinical results on that scale, but we are now in position to deliver biotech products into a primary care environment.
On whether he considered staying to work under new CEO Bob Bradway:
No. Kevin (Sharer) and I talked about this last fall, and we agreed there’s a natural time for leadership transition. It was important for a new team to take over. We wanted to try to engineer something that’s rare in this business—an orderly transition in leadership. Kevin had privilege of building a new team with George (Morrow) and me, and he wanted Bob Bradway to have the same opportunity. Both of us had groomed our successors. I have complete confidence in Sean Harper, that he will do a terrific job, and it’s time for him. I’m happy to consult, happy to provide advice, but if I’ve done my job well, pretty soon he and others won’t need my advice or want it.
On what he’s going to do next:
I’m more committed than ever to the application of fundamental research to important problems in clinical care. I’m prepared to look in a variety of things, whether that’s in the for-profit or non-profit settings. I spent a lot of time in academic environment at the University of Washington, and have a lot of respect for what people are doing there.
I’m having conversations with academic institutes and other companies. Don’t rule out the possibility that I might be involved with a small company as well. I’m no less energetic than I was 11 years ago when I took the Amgen job.
On the one thing he wishes he could do over:
I’d do everything faster. That’s easy to say. In retrospect, the decisions you make seem straightforward. But at the time, they are fraught with challenges and they take time to sort through. Doing your deliberations, while squeezing down the amount of time you spend on them, that’s a discipline.
On one big piece of advice he’s given to his successor:
I don’t know if I can’t pick just one, but I think the advice I gave to Sean (Harper) is the same I’d give to the industry. Eschew distraction. It’s the most challenging problem facing our industry. The challenge is to identify the critically important things that warrant your attention, and throw yourself 100 percent into those things.
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