December 1, 2017

AbbVie Statement on SONAR Study Closure

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Media Statement

AbbVie Closes SONAR Study Evaluating Investigational Compound Atrasentan on Renal Outcomes in Patients with Diabetic Nephropathy

NORTH CHICAGO, Ill., December 01, 2017 – AbbVie (NYSE: ABBV), a research and development-based global biopharmaceutical company, today announced its strategic decision to close the SONAR study, a Phase 3 clinical trial evaluating the effects of the investigational compound atrasentan - when added to standard of care - on progression of kidney disease in patients with stage 2 to 4 chronic kidney disease and type 2 diabetes. The ongoing monitoring of renal events observed in the study has revealed considerably fewer end-points than expected by this time, which will likely affect the ability to test the SONAR study hypothesis. Therefore, AbbVie has determined that it cannot justify continuing the participation of patients in the study. The decision to close the SONAR study early was not related to any safety concerns.

About the SONAR Study

SONAR was a randomized, double-blind, parallel, placebo-controlled, multicenter study designed to assess the effects of atrasentan (0.75 mg administered orally once a day) on renal outcomes in patients with type 2 diabetic nephropathy (diabetic kidney disease) while they continue to be treated with the current standard of care: the maximum tolerated labeled daily dose of a RAS inhibitor, such as an ACE inhibitor or an ARB, and a diuretic.
Inclusion criteria for patients includes estimated GFR (another important indicator of kidney disease progression) of 25 to 75 mL/min/1.73 m2, UACR ≥300 and <5,000 mg/g, and systolic blood pressure within 110 and 180 mmHg (inclusive).
The primary endpoint was to evaluate the effect of atrasentan on time to doubling of serum creatinine or the onset of ESRD, as defined by need for chronic dialysis, transplant or death due to renal failure. Secondary endpoints will assess the effects of atrasentan on urine albumin excretion, eGFR and cardiovascular events including cardiovascular death, heart attack and stroke.  Quality of life evaluations were also conducted.
After initial screening, patients were enrolled in a run-in period to optimize RAS inhibitor and diuretic doses.  Eligible patients entered an enrichment period, in which they received atrasentan 0.75 mg/day for six weeks to determine their UACR response and to assess tolerability of atrasentan.  

About Diabetic Nephropathy

Diabetic nephropathy is kidney disease or damage that is a common complication of diabetes[1]. Worldwide, approximately 422 million people are living with diabetes[2] and the global burden is expected to double between 2000 and 2030[3]. Complications add greatly to the already substantial costs of medical care for patients with type 2 diabetes[4].
In the US, diabetic kidney disease occurs in approximately 40 percent of all patients with diabetes[5]. Diabetes is the most common cause of kidney failure or ESRD, accounting for nearly 44 percent of new cases in the US[6]. The number of people with diabetes continues to rise and as a result, the number of people with kidney failure caused by diabetes is growing[7]. Some experts predict that diabetes might soon account for half the cases of kidney failure[8]

About Atrasentan

Atrasentan is an investigational compound that belongs to a class of drugs known as selective endothelin-A receptor antagonists, which block the effect of endothelin-l (ET-l), a peptide that constricts blood vessels in the kidney to negatively impact kidney functions. Atrasentan is a highly selective endothelin-A receptor antagonist that was discovered and is being developed internally at AbbVie.

About AbbVie

AbbVie is a global, research-driven biopharmaceutical company committed to developing innovative advanced therapies for some of the world’s most complex and critical conditions. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at Follow @abbvie on Twitter, Facebook or LinkedIn.

Forward-Looking Statements  

Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry.
Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2016 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

Jane Woo
+1 (847) 937-4754
Investor Relations:
Liz Shea
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[1] MedLine Plus - Last accessed: November 2017
[2] WHO Media Centre - Last accessed: November 2017
[3] Rathmann W, Giani G. Global prevalence of diabetes: estimates for the year 2000 and projections for 2030. Diabetes Care. 2004;27:2568–9
[4] G.A. Nichols, S. Vupputuri, H. Lau. Medical care costs associated with progression of diabetic nephropathy. Diabetes Care, 34 (2011), pp. 2374-2378
[5] de Boer IH, Rue TC, Hall YN, Heagerty PJ, Weiss NS, Himmelfarb J. Temporal trends in the prevalence of diabetic kidney disease in the United States. JAMA. 2011; 305:2532–2539.
[7] MedicineNet - Last accessed: November 2017