The drug: Bardoxolone
The disease: Chronic kidney disease
The developers: Reata, Abbott (AbbVie)
Peak sales potential: Reata believes this drug will earn billions.
At one point, Reata CEO Warren Huff had expected to take promising Phase IIb data to the FDA to prove that bardoxolone could significantly delay the need for dialysis, an economic argument that should help it realize its blockbuster potential.
Abbott ($ABT), which committed hundreds of millions in near-term payouts to partner on this program, helped persuade Huff that what they really needed to make it in the blockbuster world was a major Phase III program with hard outcomes on patients. And they launched the study in 2011--enrolling 1,600 patients with advanced kidney disease and Type 2 diabetes--with a readout expected in 2013.
By that time, Abbott will have spun out the pharma side of the operation as AbbVie, which hopes to tout bardoxolone as a prime example of its drug development prowess.
Simply put, bardoxolone suppresses oxidative stress and inflammation. Investigators are testing it in late-stage CKD patients with Type 2 diabetes.
For Reata, the stakes couldn't be higher. The company has confidently held on to the U.S. rights, expecting to set up a commercial operation as it expands into a full-fledged biopharma company with R&D as well as marketing divisions. And it's signed a rich pact with Abbott on its second-gen programs, with an eye to the more distant future.
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