Biotech Values

[DewDiligence]

ABT/Reata Start Phase-3 Trial of Bardoxolone in CKD

[According to ABT, this is the most exciting drug in the company’s late-stage pipeline. Positive phase-2b top-line data were reported in Nov 2010 (#msg-56946507), and final phase-2b data will be reported on 6/25/11 (see below). The phase-3 trial is seven-times larger than the phase-2b and is expected to be completed in Jun 2013 (http://clinicaltrials.gov/ct2/show/NCT01351675 ).

Pursuant to a partnership struck in Sep 2010 that included $450M in up-front cash, ABT owns the commercial rights to Bardoxolone in all major countries except the US and Japan (#msg-54747777). The addressable market is sufficiently large that this drug can move the needle even for a company as large as ABT. Reata, the licensor, is a private biotech from the Dallas-Ft Worth area.]

http://finance.yahoo.com/news/Reata-and-Abbott-Initiate-prnews-2289922961.html?x=0&.v=1

›Thursday June 16, 2011, 10:49 am EDT

IRVING, Texas and ABBOTT PARK, Ill., June 16, 2011 /PRNewswire/ -- Reata Pharmaceuticals, Inc. and Abbott announced today the initiation of a pivotal Phase 3 clinical trial to evaluate the safety and efficacy of bardoxolone methyl in patients with chronic kidney disease (eGFR of 15-29 mL/min/1.73 m2) and type 2 diabetes.

The trial, known as BEACON (Bardoxolone methyl EvAluation in patients with Chronic kidney disease and type 2 diabetes: the Occurrence of renal eveNts), is the first multinational, double-blind, placebo-controlled study designed to assess the impact of bardoxolone methyl on time to important clinical outcomes. Approximately 1,600 patients at 300 sites worldwide – including in Austria, Australia, Belgium, Canada, Czech Republic, France, Germany, Israel, Italy, Mexico, Spain, Sweden, United Kingdom and United States – will be enrolled in the trial and randomized 1:1 to receive 20 mg of a reformulated version of bardoxolone methyl or placebo once daily. Results are expected in 2013.

The primary efficacy endpoint will be a time-to-first-event composite consisting of progression to end-stage renal disease (ESRD), defined as the need for chronic dialysis or renal transplant, and cardiovascular death. Secondary endpoints will include change in estimated glomerular filtration rate (eGFR) and a time-to-first-event composite consisting of hospitalization for congestive heart failure (CHF), non-fatal myocardial infarction (MI), non-fatal stroke and cardiovascular death.

More information on the trial is available at www.clinicaltrials.gov (clinical trial identifier: NCT01351675).

"We are pleased to announce that the Phase 3 BEACON trial is underway," said Pablo E. Pergola, M.D., Ph.D., Director of Renal Associates' Research Division in San Antonio, Texas, who screened the first patient of the study. "There are few therapeutic options available today that slow the progression of CKD. Results from the Phase 2 BEAM trial suggest that bardoxolone methyl may improve measures of kidney function in patients with moderate to severe CKD and Type 2 diabetes. We look forward to further evaluating the drug candidate's effects on clinical outcomes in this patient population."

Final results from the 52-week Phase 2b BEAM study will be presented during a Late-Breaking Clinical Trials session on June 24 [see #msg-56946507 for top-line results] at the 2011 European Renal Association-European Dialysis and Transplant Association (ERA-EDTA) Congress in Prague, Czech Republic.

About Chronic Kidney Disease

Chronic kidney disease (CKD) is a progressive loss of kidney function over a period of months or years that can be caused by a number of conditions, including diabetes and high blood pressure. CKD is a highly prevalent condition worldwide with numbers expected to rise over the next decade. In the United States there are more than 26 million patients with CKD, and more than 500,000 patients with ESRD.

About Bardoxolone Methyl

Bardoxolone methyl is a novel, first-in-class antioxidant inflammation modulator (AIM). Bardoxolone methyl is an Nrf2 activator, thereby inducing the transcription of genes that reduce oxidative stress and suppress important inflammatory mediators.

In January 2010, Reata and Kyowa Hakko Kirin (KHK) announced a licensing agreement providing KHK with the exclusive rights to develop and commercialize bardoxolone methyl in Japan and other selected Asian markets. In September 2010, Reata formed a strategic partnership with Abbott for the commercialization of bardoxolone methyl in other ex-U.S. markets. Reata retains exclusive rights to bardoxolone methyl in the U.S.‹