Accepted by the Chairperson of the Board
Voluntary Compliance Undertaking of Eisai Limited to the Patented Medicine Prices Review Board
1. Product Summary
1.1 Banzel (rufinamide) 100 mg (DIN 02369613) and 200 mg (DIN 02369621) tablets is prescription medication approved for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in children four years and older and adults.
1.2 Canadian Patents No. 2,256,013, No. 2,256,015, No. 2,260,065, No. 2,362,411, No. 2,614,926 and No. 2,622,541 pertaining to Banzel were issued on October 16, 2007, June 3, 2008, October 17, 2006, November 24, 2009, February 9, 2010 and August 23, 2011 respectively, to Novartis AG, Switzerland. The last patent will expire on February 28, 2020. Eisai Limited is the patentee for purposes of the Patented Medicine Prices Review Board (PMPRB).
1.3 A Notice of Compliance was granted to Eisai Limited for Banzel on June 22, 2011. Banzel 100 mg and 200 mg tablets were first sold in Canada on October 14, 2011 and August 30, 2011 respectively.
2. Application of the Guidelines
2.1 The Board's Human Drug Advisory Panel (HDAP) identified Banzel as a new medicine offering slight or no therapeutic improvement. The introductory national average transaction prices (N-ATPs) of $0.8423 per tablet for the 100 mg tablet and $1.5810 per tablet for the 200 mg tablet exceeded the maximum average potential prices (MAPPs) of $0.7034 and $1.4069 by margins of 19.7% and 12.4% and generated excess revenues of $875.07 and $3,196.48, respectively.
2.2 As of December 31, 2011, there were cumulative excess revenues of $4,071.55 for the two dosage forms of Banzel.
3. Position of the Patentee
3.1 This Voluntary Compliance Undertaking (VCU) constitutes no admission by Eisai Limited that the price of Banzel is or was excessive for purposes of the Patent Act.
4. Terms of the Voluntary Compliance Undertaking
In order to comply with the Guidelines, Eisai limited undertakes as follows:
4.1.1 To agree that the 2011 and 2012 national non-excessive average prices (N-NEAPs) of Banzel 100 mg and 200 mg tablets are as follows:
||100 mg tablet
||200 mg tablet
4.1.2 To ensure the 2012 N-ATPs of Banzel 100 mg and 200 mg tablets do not exceed the 2012 N-NEAPs of $0.7182 and $1.4364 respectively;
4.1.3 To offset the cumulative excess revenues received from October 14, 2011 to December 31, 2011 for the 100 mg tablet and August 30, 2011 to December 31, 2011 for the 200 mg tablet, by making a payment of $4,071.55 to Her Majesty in right of Canada, within 30 days of the acceptance of this VCU;
4.1.4 To offset any excess revenues remaining as of December 31, 2012 as a result of selling Banzel 100 mg and 200 mg tablets at a price in excess of the Guidelines by making a payment to Her Majesty in right of Canada not later than March 1, 2013.
4.1.5 To ensure that the prices of Banzel 100 mg and 200 mg tablets remains within the Guidelines in all future periods in which Banzel is under the PMPRB's jurisdiction.
Original signed by:
Company Officer: Takihiro Hirasawa
Position: President, Eisai Ltd
Date: October 09, 2012