Until recently it seemed like the only thing big pharmaceutical companies wanted from the little guys was their drugs—as many of them as the pharmas could get their hands on. Things have changed, however, as yesterday’s deal between Cambridge, MA-based Aveo Pharmaceuticals and Eli Lilly demonstrates. Now, there is something else those pharmas desperately want from biotech—biomarkers, or molecular tests that drugmakers can use during development to understand exactly how their drug candidates work in people.
Aveo and some other local companies are finally starting to benefit from that trend. Eli Lilly, for instance, is paying Aveo an undisclosed amount to help the pharma figure out which patients respond best to a new cancer drug Lilly is developing.
At stake is millions of dollars in research money spent on drugs that stumble and fall before reaching the finish line. Failed drugs have cost big pharma dearly recently, and more than anything right now they’d like to staunch the bleeding. Companies like Aveo are concentrating on making better tools to sniff out biomarkers—proteins, metabolites, and other molecules in the body that give clues about whether a would-be drug is reaching its target, having the desired effect, or causing toxicity—early. Aveo’s particular strength is an ingenious new mouse model of cancer that provides a much better facsimile of human tumors that do conventional experimental systems, as David Stipp described in his profile of Aveo this summer.
Indeed, the lion’s share of biomarker work is going on in oncology, where new science has opened up a goldmine of new targets for drugs. Here, the FDA has made it pretty clear that if a company is going to claim it has a drug targeted at a specific molecule or mechanism, the agency wants to see data from biomarker tests showing how the drug affects that target. If the drug is only working in a specific subset of patients—or if it causes unacceptable side effects in a subset of patients—the FDA wants to the biomarker data on that phenomenon as well.
Aveo has so far been a big winner in this burgeoning market for biomakers, inking deals with Merck, OSI Pharmaceuticals, and Schering Plough as well. But it is not the only one cashing in; I’ve heard from many of my sources that they’re seeing a bump in the biomarker business. At a conference just a few weeks ago I was talking to Daniel W. Paterson, president and CEO of The DNA Repair Company (or DNAR), a low-profile Boston-based startup that Paterson says is already discussing deals with several pharmas around biomarkers for cancer drugs. “In oncology, companies have to have these markers,” he said. “It’s the first time I’ve been at a company where big pharma is calling us.”