Voluntary Compliance Undertaking of Novartis Pharmaceuticals Canada Inc. to the Patented Medicine Prices Review Board

1.0 Product Summary

1.1 Lamisil® 250mg/tablet (terbinafine hydrochloride) is indicated in the treatment of fungal infections of the skin and nails caused by dermatophytes such as Trichophyton (e.g. T. rubrum, T. mentagrophytes, T. verrucosum, T.violaceum), Microsporum canis, Epidermophyton floccosum and yeasts of the genus Candida (eg. C.albicans), as well as Malassezia furfur.

1.2 Canadian Patent 2,536,498 pertaining to Lamisil® 250mg/tablet was granted to Novartis AG (Switzerland) on October 9, 2012, and will expire on August 27, 2024. A previous Canadian patent (1,157,023) pertaining to Lamisil expired on November 15, 2000.

1.3 Health Canada issued a Notice of Compliance (NOC) for Lamisil® 250mg/tablet on May 4, 1993. Sales in Canada commenced May 5, 1993. Novartis Pharmaceuticals Canada Inc. is the patentee for purposes of the Patented Medicines Prices Review Board (PMPRB).

2.0 Application of the Excessive Price Guidelines

2.1 In May 1993, the introductory price of Lamisil® 250 mg/tablet was within the Board's Guidelines. The price remained within the Guidelines until the end of 2000.

2.2 In November 2000, patent 1,157,023 expired, ceasing the PMPRB's jurisdiction over the price of Lamisil® 250 mg/tablet. In October 2012, patent 2,536,498 was granted giving the PMPRB jurisdiction back to its laid open date of March 2005.

2.3 In 2006, the price of Lamisil® 250mg/tablet exceeded the Guidelines triggering the investigation criteria based on the CPI-Adjustment Methodology. In particular, the 2006 National Average Transaction Price (N-ATP) was 3.2% above the National Non-Excessive Average Price (N-NEAP), resulting in excess revenues above $50,000. As of December 31, 2013, cumulative excess revenues were $425,034.25. From 2008 to 2013, the N-ATPs have remained below their respective N-NEAPs.

3.0 Position of Patentee

3.1 This Voluntary Compliance Undertaking (VCU) constitutes no admission by Novartis Pharmaceuticals Canada Inc. that the prices of Lamisil® 250mg/tablet are or were excessive for purposes of the Patent Act.

4.0 Terms of the Voluntary Compliance Undertaking

In order to comply with the Guidelines, Novartis Pharmaceuticals Canada Inc. agrees to undertake the following:

4.1 To agree that the N-NEAPs for Lamisil® 250mg/tablet are as follows:

2006 $3.6435
2007 $3.7601
2008 $3.7709
2009 $3.7440
2010 $3.8307
2011 $3.8518
2012 $3.7856
2013 $3.8341
2014 $3.8818

4.2 To make a payment to Her Majesty in right of Canada in the amount of $425,034.25 within 30 days of the acceptance of this VCU.

4.3 To ensure that the price of Lamisil® 250mg/tablet remains within the Guidelines in all future periods in which Lamisil® 250mg/tablet is under the PMPRB's jurisdiction.

Original signed by: Lison Prévost
Position: Head, Key Account Management and Payers
Patentee: Novartis Pharmaceuticals Canada Inc.
Date: June 26, 2014