Failed ALS study haunts Biogen in lawsuit from unhappy partner

Biogen CEO George Scangos

Biogen Idec ($BIIB) has been unable to shake off Knopp Neurosciences, from which Biogen licensed a compound against Lou Gehrig's disease that fell short in a recent late-stage study. Now little Knopp is taking big Biogen to court with a lawsuit demanding patient samples from the failed Phase III study of dexpramipexole, a candidate drug for amyotrophic lateral sclerosis (ALS), Bloomberg reported.

The dexpramipexole flameout put a rare zit on Biogen CEO George Scangos' mostly clean R&D record, as the company pulled the trigger on the deal with Knopp to gain rights to the compound early on in the chief executive's tenure in summer 2010. Despite the failure, Biogen has stayed invested in researching ALS and potential therapies against the mysterious neurodegenerative disease, working with academics at Duke, UMass and elsewhere to uncover the unknown biology of the disease.

Yet now Knopp is making sure that Scangos and company don't forget about the Phase III misfire. As Bloomberg reports, a U.S. District Court judge in Boston has slated a quick bench trial in June to hear Knopp's case against the biotech giant for breach of contract.

Though Biogen shut down the late-stage Empower study because of a lack of efficacy shown in patients on Knopp's drug, Knopp contends that its own analysis spotted a subgroup with some signs that the treatment slowed progression of the disease. The newswire reports that Knopp wants to the Empower study's patient samples from Biogen to investigate the finding further, and the dispute centers on whether Biogen is obligated to give up the samples, which the company says it wants for its own research.

"The failure to preserve the Empower biosamples, and ultimately to investigate them using the right tools in the right hands, will represent a research setback during which time thousands of patients will have died of ALS," Knopp said in its complaint, as quoted by Bloomberg.

This dispute appears to be a much bigger deal for Knopp than Biogen, which is laser focused on gaining an expected FDA approval for its multiple sclerosis pill BG-12 this month and later launching the blockbuster hopeful on the market.

- here's Bloomberg's article

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