Accepted by the Chairperson of the Board
Voluntary Compliance Undertaking of Pfizer Canada Inc. to the Patented Medicine Prices Review Board
1.0 Product Summary
1.1 Lyrica 75 mg/tab (pregabalin), a patented medicine sold in Canada by Pfizer Canada Inc. (Pfizer), is indicated to treat fibromyalgia, diabetic nerve pain, and pain after shingles. Lyrica is also indicated to treat partial onset seizures in adults with epilepsy who take one or more drugs for seizures.
1.2 Health Canada issued a Notice of Compliance (NOC) to Pfizer for the sale of Lyrica 75 mg/tab on June 3, 2005 and sales began in Canada on August 4, 2005.
1.3 The first-filed Canadian patent (No. 2,134,674) pertaining to Lyrica was granted to Warner-Lambert Company, USA on December 21, 2004 and will expire on May 18, 2013. The last patents pertaining to Lyrica (Nos. 2,325,045 and 2,327,285) were granted on May 10, 1999 and will expire on May 10, 2019. Pfizer is the patentee for purposes of the PMPRB.
2.0 Application of the Excessive Price Guidelines
2.1 The August to December 2005 introductory price of Lyrica 75 mg/tab was reviewed in accordance with the Board's Excessive Price Guidelines and was found by Board Staff to be within the Guidelines.
2.2 The national average transaction price (N-ATP) exceeded the national non-excessive average price (N-NEAP) in 2009, resulting in excess revenue which did not trigger the investigation criteria.
2.3 The N-ATP continued to exceed the N-NEAP in 2010, resulting in cumulative excess revenues of $63,981.64 as of December 31, 2010, which triggered the investigation criteria. In 2011, the N-ATP was within the Guidelines.
3.0 Position of the Patentee
3.1 This Voluntary Compliance Undertaking (VCU) constitutes no admission by Pfizer that the price in Canada of Lyrica 75 mg/tab is or was excessive for purposes of the Patent Act.
4.0 Terms of the Voluntary Compliance Undertaking (VCU)
4.1 In order to comply with the Guidelines, Pfizer agrees to the following:
4.1.1 To agree that the N-NEAPs of Lyrica 75 mg/tab are as follows:
||Lyrica 75 mg/tab
4.1.3 To offset the cumulative excess revenues received from January 1, 2009 to December 31, 2010 by making a payment to Her Majesty in right of Canada in the amount of $63,981.64 within 30 days of the acceptance of this VCU;
4.1.4 To offset any excess revenues received by Pfizer from January 1, 2012 to the date of acceptance of this VCU by making a payment within 30 days of the filing of semi-annual price and sales data as required by the Patented Medicines Regulations, in the amount of the excess revenues, as calculated by Board Staff, received as a result of selling Lyrica 75 mg/tab at a price in excess of the 2012 N-NEAP; and
4.1.7 To ensure that the price of Lyrica 75 mg/tab remains within the Guidelines in all future periods during which Lyrica 75 mg/tab is under the PMPRB's jurisdiction.
Pfizer Canada Inc.
Signature: Original signed by
Company Officer: Ghislain Boudreau
Position: VP Public Affairs
Date: 07 November 2012