The developer: Roche, pRED
The drug: aleglitazar
The scoop: Roche's ($RHHBY) Basel-based pRED group knew it had a bad problem long before the diabetes drug aleglitazar was declared a total loss a few weeks ago. The pharma giant had decided to blow up its campus in Nutley, NJ, in 2012 in search of a workable strategy. John Reed was brought in from Sanford-Burnham last spring to take the helm.
The failure, though, underlined some important messages at Roche. Generalized medicine is out, Reed declared to FierceBiotech recently. You won't see any more programs like this at pRED--let alone its sister operation gRED in California.
The drug turns on protein receptors known as PPARs. In Phase II, a small group responded well to the drug. But four years ago, Dr. Bernard Charbonnel, of the University of Nantes in France, noted in a piece on PPARs that more than 50 such drugs had failed clinical trials due to safety concerns. The defeat of muraglitazar and tesaglitazar in Phase III was the crowning setback for many experts, casting a permanent pall on the whole field.
The latest failure also raises some important questions about GlaxoSmithKline's ($GSK) Avandia.While aleglitazar activated both PPAR alpha and gamma, Avandia targeted primarily the gamma receptor. Questions about its safety spurred European regulators to red-flag the drug while the FDA severely restricted its use. But an advisory panel recently called on the agency to loosen its restrictions.
Roche's decision to ax aleglitazar after a safety review also underscores another important trend in the global biopharma business. You don't have to wait until the final bit of data from the final study demonstrates utter futility before you call it a day. While the underlying scientific observations that drove this drug were discredited years ago, Roche gets a thumbs up for a better-late-than-never recognition that it can be far better to admit your defeats and move on than linger until the absolute bitter end.
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