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they understand what we were trying to do, and so we in R&D understood the insights they had from the marketplace. That was what we were trying to do.
On what he considered the biggest accomplishment, other than the FDA approval of denosumab:
Early on, the company registered a longer half-life version of epoetin, which was darbepoetin (Aranesp). That’s a very successful drug and continues to be. It certainly had a large commercial impact. You can argue that the extension of half-life was not so important to patients, but it is an important drug. Enbrel is a hugely important drug around the world, and would never have attained the success it attained without the energy and effort we put behind it. Sometimes it is underappreciated how much work it takes to build new indications into an existing drug. Immunex discovered and developed it for rheumatoid arthritis, but subsequent registration programs and process development improvements gave us the ability to manufacture the drug at scale. Those process development improvements were hugely important for enabling us to expand the use of the drug for conditions like psoriatic arthritis, ankylosing spondylitis, and psoriasis.
Other drugs that get less attention are quite important. At time I came here, Sensipar was in clinical trials for secondary hyperparathyroidism (in kidney dialysis patients). It was our first small molecule. We built up expertise to do large-scale clinical trials, and that drug is selling nearly $1 billion a year. That’s a pretty big drug, pretty important. Now we’re awaiting the outcome of the Evolve study, which will show whether we can reduce cardiovascular morbidity and mortality. That’s a substantial, important thing. If look at romiplostim (Nplate), that drug is not a giant seller in billions of dollars, but has had a big impact in patients with autoimmune platelet destruction. It continues to grow dramatically.
On the change to the organization’s capabilities:
We were principally active in North America when I came here, and now we have development in over 50 countries. It was a pretty big expansion. We ran the kind of global trials that you saw for denosumab, such as the Freedom study, an 8,000-patient study. That was not something the company was capable of doing when I got here in 2001. The study started in 2004. I think we should all feel pretty good about that.
The big question now for our development organization is what the future looks like. The answer is we’ve got seven major programs in late-stage clinical trials. For a company of any size, that’s a lot. My proudest achievement is surely in building this organization. I’m very proud of the Amgen R&D organization, what it has achieved and what it can achieve. It’s responsible for important products like denosumab, but also provides the basis for durable advancement in human health.
On his biggest disappointment:
There’s so many, it’s hard to know where to start. There have been numerous programs I lavished attention on that turned out … Next Page »
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