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Companies seek game-changer for CKD
ABBOTT PARK, Ill.—Abbott Laboratories has agreed to pay Reata Pharmaceuticals Inc. $450 million in upfront and near-term cash payments in exchange for the exclusive rights to develop and commercialize Reata's pivotal-stage chronic kidney disease (CKD) candidate, bardoxolone methyl, worldwide, excluding the U.S. and certain Asian markets.
Under the agreement, announced Sept. 23, Irving, Texas-based biotech firm Reata will retain exclusive rights to bardoxolone in the United States, the largest CKD market in the world. Reata is also eligible for milestones totaling $350 million, plus sales royalties.
If successful, bardoxolone methyl could be considered the elixir for 20 million Americans diagnosed with moderate to serious CKD, a life-threatening illness expected to increase alongside the rising numbers of obesity cases forecast over the next four decades. Half of CKD patients also have diabetes, the leading cause of CKD, with as many as 30 to 40 percent of type 2 diabetics developing the disease.
The market for CKD therapeutics is $13 billion annually, and is expected to grow to $20 billion by 2016.
Reata partnered on bardoxolone with Kirin last December for $272 million plus royalties for marketing rights in certain Asian markets. Bardoxolone is an oral antioxidant inflammation modulator (AIM) that activates the transcription factor Nrf2, which Reata says leads ultimately to a decrease in the level of oxidative stress and suppresses a number of inflammatory mediators. The potentially life- changing drug is currently in late Phase II trials for the treatment of CKD.
The partnership "allows us to meet our strategic goal of establishing our own commercial presence in the U.S. and building a sustainable, fully integrated pharmaceutical company," says Reata CEO Warren Huff.
Current available therapies slow the progression of CKD, but patients ultimately progress to dialysis. Not only have clinical studies shown early promise, but this is the first time a drug has shown this level of sustained improvement in CKD patients, Huff says.
"We've been working on this for years," Huff tells ddn. "When we had compelling clinical data, Abbott was interested in the partnership—especially offshore."
Abbott, for its part, now adds to its pipeline a late-stage drug for diabetes-associated kidney disease. Bardoxolone has the potential to cover Abbot's bill, which can increase to as much as $900 million, healthcare experts estimate. The deal also gives Abbott rights to certain other Reata compounds for CKD, cardiovascular and metabolic indications in the same territories.
Tracy L. Sorrentino, a spokeswoman for Abbott, tells ddn that the partnership "provides Abbott with a late-stage clinical asset, consistent with our strategy to augment our pharmaceutical pipeline with external compounds and expertise."
"Reata has a very promising compound that has the potential to be the first the first disease-modifying treatment option for CKD, while Abbott brings decades of expertise in renal care, plus clinical development and regulatory expertise—particularly outside the U.S.—and we have a commercial presence in renal with Zemplar," Sorrentino says.
Abbott claims the Reata drug represents a promising new addition to its late-stage pipeline and will build on its existing expertise in renal care. Phase II studies with the drug in patients with stage 3b and 4 CKS and type 2 diabetes have shown that treatment results in statistically significant increases in estimated glomerular filtration rate and improvements in other key markers of renal function, the company reports.
"Early clinical studies suggest that bardoxolone could be a significant improvement to the current standard of care for chronic kidney disease and possibly prevent patients from progressing to the later stages of the disease and dialysis," says Dr. John Leonard, senior vice president of pharmaceuticals R&D at Abbott.
Both companies will work together on the clinical development plan, including regulatory filings, while commercialization costs will be covered by the territory owner. Reata is responsible for funding R&D expenses.
"It's too soon to say what the commercial potential might be, but we feel sales could be significant, given the patient need and the data we have seen in the clinical trials," Sorrentino says.