- Reata Pharmaceuticals said Thursday it will pay AbbVie $330 million over the next two years to re-acquire most of the ex-U.S. rights for its leading drug candidates.
- In 2010, AbbVie, then still a part of Abbott, paid $450 million for those international rights to bardoxolone methyl along with other experimental compounds in an R&D deal. Now, Reata will hold nearly worldwide commercialization rights for its lead drugs, with the exception of Asian markets for bardoxolone, which the company licensed to the Japanese pharma Kyowa Kirn in 2010.
- Investors appeared to embrace the deal, with the Texas-based biotech's stock jumping nearly 10% Thursday morning. In a down year for most of biotech, Reata's stock has climbed up nearly 50% since the beginning of the year, now trading at about $82 apiece.
The final quarter of 2019 is shaping up to be a fateful one for Reata, with the biotech now doubling down on its lead therapeutic candidates in bardoxolone and omaveloxolone ahead of crucial data readouts.
Both drugs target the transcription factor NRF2 and have pivotal trials, dubbed CARDINAL and MOXIe, set to give topline results by the end of 2019.
"We are still blinded for the data for both," Reata CFO Manmeet Soni said Thursday in an interview with BioPharma Dive. "This is a very strong move from our side. It shows our confidence, but we'll have to see how the data plays out."
Soni, previously a CFO at Alnylam Pharmaceuticals, Ariad Pharmaceuticals and Pharmacylics, joined the biotech in August. He added that AbbVie had expressed little interest in those therapeutic areas with core focuses elsewhere, and it's been a priority for the company to regain those rights.
Bardoxolone is being tested in CARDINAL, a Phase 3 study of 157 patients with Alport syndrome. The company expects to file for accelerated approval if the topline results show retained eGFR, a measure of kidney function, after a year of treatment. That endpoint suggests the drug could prevent or delay kidney failure, according to Reata.
There are no approved therapies for Alport syndrome. The biotech has already begun commercial preparations, including developing a genetic testing program for the rare condition and launching a disease awareness campaign, according to an October company presentation.
Omaveloxolone is also expected to have a pivotal readout by year's end with the MOXIe trial. That study is testing 103 patients with the rare genetic disease Friedreich's ataxia to see if the drug can improve patient scores on a disease-specific rating scale.
Exact timing for both readouts remains unknown, but Soni reaffirmed both are expected by year's end.
If all goes well, the company anticipates expanding both drugs into larger patient populations.
Bardoxolone is targeting a range of various patients afflicted with chronic kidney disease, with a Phase 3 study started in May for autosomal dominant polycystic kidney disease, or ADPKD.
The company also expects omaveloxolone could be developed in other neuromuscular disease if MOXIe data turn out positive.