Voluntary Compliance Undertaking for Evra – Update

OTTAWA, March 1, 2005: Pursuant to the Voluntary Compliance Undertaking (VCU) approved by the Board on Feburary 21, 2005, to reduce the price of Evra, Janssen-Ortho will also reduce the price of Levaquin.

The terms of the VCU require Janssen-Ortho to lower the price of Evra by 45% to $4.47 per patch. Also, to offset excess revenues from past sales of Evra accrued from the date of first sale to June 30, 2004, Janssen-Ortho will make a payment to the Government of Canada in the amount of $1,359,263.67. Finally, the balance of excess revenues remaining, totalling $1,496,019.02, for the period July 1, 2004 to December 31, 2004, will be offset by reducing the price of one of Levaquin 5mg/mL (DIN 02236839) and 25mg/mL (DIN 02236840) as of March 1, 2005.

In the event that the full amount of the excess revenues is not offset by December 31, 2005, Janssen-Ortho Inc. will offset any remaining excess revenues by making a further payment to the Government of Canada no later than January 31, 2006.

For more information on this matter, please contact the Secretary of the Board at (613) 954-8299 or by e-mail at: sdupont@pmprb-cepmb.gc.ca.