The unified theory of biomarkers: Stromedix and Biogen Idec

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Biogen Idec has signed a deal to buy Stromedix for $562.5 million, which has resulted in the big biotech in the process buying back the lung disease drug that it licensed to Stromedix in 2007. So what's changed over five years? Sit back and relax--it's a slightly convoluted story, but it does have a biomarker-flavored ending.

Stromedix CEO Michael Gilman was executive vice president of research at Biogen Idec ($BIIB) in 2005 when he decided to strike out alone with the idea to set up a company based on the treatment of fibrosis, an area of well-established biology, unmet medical need and no approved drugs. He started hunting around for likely candidate drugs and programs.

"I knew about Biogen Idec's in-house fibrosis program, but at the time it wasn't available, so I discounted it. Then in 2006 Biogen Idec shelved the fibrosis program as part of its strategic review. So I started calling up the company, and we talked, and after around 10 months of negotiation, we signed a deal to in-license the program that included STX-100, which we then took into a Phase I trial and prepared to begin a Phase II study in idiopathic pulmonary fibrosis," says Gilman.

Biogen Idec retained board observer rights and had an equity investment in Stromedix, and had also manufactured clinical trial quantities of STX-100. After a significant change at Biogen Idec, and a major revision of the portfolio, the big biotech started to look at the fibrosis program again, now entering Phase II.

"After Biogen Idec's revision of its pipeline, it was left with something rather 'dumbbell-shaped,' with therapeutics at early stages and in Phase III, and not much in the middle, so our drug, or their old drug, started to look interesting. They decided that it could fill the gap and they went ahead with the acquisition, which closed in February 2012." After the closure of the agreement, Gilman won't have much farther to go to work--Biogen Idec is just four blocks away from Stromedix!

So why is this particularly interesting to readers of FierceBiomarkers? Well, fibrotic diseases are slow-moving and it's hard to measure the efficacy of drugs in shorter early clinical trials. Late-stage clinical trials would need to be long, and therefore costly, with endpoints such as survival or loss of organ function. All fibrotic diseases have a common mechanism, involving the activation of TGF-beta--so by creating a biomarker panel that will indicate whether a candidate drug is having an impact on this pathway, the researchers will have an idea whether a drug is active in a number of fibrotic diseases, and this could even have potential as a surrogate endpoint.

"We had an 'aha' moment--the macrophages in the lung are responsive to TGF-beta, and so we could use these cells as biosensors for anti-TGF beta drug activity – if we sampled the macrophages and followed the TGF-beta biomarkers before and after treatment we could get an idea of the effect of the drug in the lung, and even the active dose," says Gilman. "We have biomarker data in the kidney, lung and other organs. Biomarkers are the crucial link in getting things right--perhaps even the closest we have to a unified field hypothesis in drug development--and it may have been the biomarkers that were the key to bringing Biogen Idec back to the drug!" — Suzanne Elvidge (email)

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