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ABT > SEC Filings for ABT > Form 8-K on 18-Oct-2012All Recent SEC Filings

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Form 8-K for ABBOTT LABORATORIES


18-Oct-2012

Other Events


Item 8.01 Other Events

On October 17, 2012 Reata Pharmaceuticals informed Abbott that it is discontinuing the Phase 3 clinical study, known as BEACON, designed to evaluate bardoxolone methyl in patients with advanced (stage 4) chronic kidney disease (CKD) and type 2 diabetes. The discontinuation is based on a recommendation from the study's Independent Data Monitoring Committee (IDMC) regarding safety concerns due to "excess serious adverse events and mortality in the bardoxolone methyl arm." Regulatory Agencies have been notified of this decision, and study sites and study participants are currently being informed.

Reata and Abbott will closely examine the data from this study to determine whether there is an appropriate path forward for the development of bardoxolone methyl in chronic kidney disease or other indications.

Abbott has the rights to bardoxolone methyl outside the U.S., excluding certain Asian markets.

- Private Securities Litigation Reform Act of 1995 -

A Caution Concerning Forward-Looking Statements

Some statements in this Form 8-K may be forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. Abbott 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. Economic, competitive, governmental, technological and other factors that may affect Abbott's operations are discussed in Item 1A, "Risk Factors," to our Annual Report on Securities and Exchange Commission Form 10-K for the year ended Dec. 31, 2011 and in Item 1A, "Risk Factors," to our quarterly report on Securities and Exchange Commission Form 10-Q for the quarter ended June 30, 2012, and are incorporated by reference. Abbott undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments.


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