With the backing of Novo A/S, Irving, TX-based Reata Pharmaceuticals has raised a whopping $78 million round to finance a final pivotal program for a new therapy for chronic kidney disease and Type 2 diabetes. The new money brings Reata's total venture funding to $180 million.
Reata's eggs have been clustered in the bardoxolone basket, a drug which activates the Nrf2 gene and improves the filtration rate of the kidneys, a physical signpost that deteriorates quickly in the face of CKD or diabetes. As Reata CEO Warren Huff explained to FierceBiotech early this year, the FDA has indicated that it will accept the results of an ongoing Phase IIb trial as pivotal, with a confirmatory Phase III study leading to a possible approval as early as 2012.
"The 78 (million) takes us to an NDA filing," Huff tells FierceBiotech today. The CEO adds that Novo A/S and its other big investor, CPMG, got a look at the six-month data from the IIb trial--the primary endpoint--before pulling the trigger on the new financing round. But Reata will hold on to the results until it completes the 12-month study and lays it all out at a scientific meeting in November. The Phase III can run next year, laying the stage for a possible IPO at some point as Reata prepares to make a transition to a commercial operation.
If all goes according to plan, Reata is planning to build its own commercial operation to sell the drug in the U.S. In January Reata scored a $272 million licensing pact with Kyowa Hakko Kirin covering Japan and a slate of key Pacific Rim countries, with $35 million of that arriving as an upfront payment. And it's currently looking for partners in Europe and other markets.
"We're initiating discussions with a whole range of partners," says Huff. "It's a huge commercial opportunity and we'll need help offshore."
- here's the press release