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Amgen Looks to Biomarkers to Boost Its Batting Average in Developing New Drugs

Amgen had an epiphany of sorts a little more than four years ago. The world’s largest biotech company decided clinical trials had become too much of a crapshoot, and it needed to shake up its way of developing new drugs. This really isn’t unique to Amgen, it’s more like an industry emergency. Drug companies spent $44.5 billion on research and development last year, yet last year they managed to produce the fewest number of new medicines in 24 years, a big reason why companies are scrambling for a better way.

One of Amgen’s strategies is to gather samples from patients in early-stage clinical trials, and study them for biomarkers, or signature proteins, that can offer clues about whether the drug’s working (or not). Amgen now has a team of 240 people doing work in this area, which it calls medical sciences. Company scientists in Seattle with expertise in clinical immunology and computational biology are teaming up with molecular biology experts in Cambridge, MA, and people with other skills in the San Francisco Bay Area, as well as at headquarters in Thousand Oaks, CA.

Their job is to run a gauntlet of questions about drugs in the early phases of development, says Scott Patterson, Amgen’s executive director of medical sciences. Is the drug hitting its intended target on human cells? What affect is it really having on the biological pathway envisioned in the lab? Can the samples offer insight into the best possible dose? Perhaps most importantly, can the samples show Amgen how to stratify patients based on who’s likely to benefit from the drug, and who isn’t?

“This gives us greater confidence in our drugs as they move through the pipeline,” Patterson says. “You’ve got to have confidence to make the investments to take them through development.”

The biomarker analysis is being applied across the company’s pipeline, but the most visible example of how this is playing out for Amgen is with the colorectal cancer drug Vectibix. It was first approved in the U.S. in September 2006 and is designed to block the same protein on cells as ImClone Systems’ Erbitux, the pioneering colorectal cancer drug that was approved in February 2004.

Amgen paid a fortune—$2.2 billion—in 2006 to acquire Abgenix to get full control over Vectibix. Yet the drug has not emerged as the kind of $2 billion-a-year commercial success originally predicted by analysts. That’s partly because a study in March 2007 was halted when it showed Vectibix raised the risk of death in a clinical trial when used in tandem with Genentech’s Avastin, another colorectal cancer drug that works differently.

Instead of letting Vectibix fade into a treatment of last resort, Amgen went back to what it learned from tumor samples collected from earlier trials. When the company filtered patients based on whether they had a normal gene called KRAS, or a mutated form of the gene that amplifies tumor growth, they found a striking result. … Next Page »

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