8-KOther EventsExhibits & Filings

JOHNSON & JOHNSON 8-K Report, Corporate Update (Aug 6, 2012)

Filed August 6, 2012For Securities:JNJ

Summary

Johnson & Johnson (JNJ) announced a significant development in its Alzheimer's research program, reporting the discontinuation of Phase 3 clinical development for bapineuzumab intravenous (IV) in mild-to-moderate Alzheimer's disease. This decision, made by the Joint Steering Committee of the Alzheimer's Immunotherapy Program (AIP), a partnership between JNJ's subsidiary Janssen Alzheimer Immunotherapy (Janssen AI) and Pfizer, was based on the failure of the drug to meet its co-primary clinical endpoints in two key studies (Studies 301 and 302). While this news represents a setback for JNJ's Alzheimer's pipeline, the company has quantified the financial impact. JNJ anticipates recording an after-tax, non-cash special item charge to earnings of between $300 million and $400 million in the third quarter of 2012. This charge pertains to in-process research and development related to the discontinued bapineuzumab IV program. Investors should note that this is a non-cash charge, meaning it does not involve an outflow of cash but will affect reported earnings.

Key Highlights

  • 1Discontinuation of Phase 3 clinical development for bapineuzumab IV in mild-to-moderate Alzheimer's disease.
  • 2The decision was based on bapineuzumab IV failing to meet co-primary clinical endpoints in two Janssen AI-led studies (301 and 302).
  • 3Janssen AI, a subsidiary of Johnson & Johnson, is a partner with Pfizer in the Alzheimer's Immunotherapy Program (AIP).
  • 4Johnson & Johnson expects to record an after-tax, non-cash charge to earnings of $300-$400 million in Q3 2012 related to this discontinuation.
  • 5The charge is classified as a special item related to in-process research and development.
  • 6The discontinuation impacts JNJ's efforts in treating mild-to-moderate Alzheimer's disease.
  • 7A press release dated August 6, 2012, provides further details and is attached as an exhibit.

Frequently Asked Questions

The development of bapineuzumab IV was discontinued because it failed to meet the co-primary clinical endpoints in the two key Phase 3 studies (Studies 301 and 302) for mild-to-moderate Alzheimer's disease.

Johnson & Johnson expects to record an after-tax, non-cash special item charge of between $300 million and $400 million in the third quarter of 2012. This charge relates to in-process research and development associated with the discontinued bapineuzumab IV program.

This filing specifically addresses the discontinuation of bapineuzumab IV in mild-to-moderate Alzheimer's disease. It does not provide information about the status of other potential Alzheimer's research or development programs within Johnson & Johnson's pipeline.

The decision was made by the Joint Steering Committee for the Alzheimer's Immunotherapy Program (AIP), which is a collaborative program between Janssen Alzheimer Immunotherapy (a subsidiary of Johnson & Johnson) and Pfizer.