VCU accepted on April 26, 2003
Voluntary Compliance Undertaking
1.0 Product Summary:
1.1 Aromasin (exemestane) is a selective steroidal aromatase inhibitor indicated for the treatment of advanced breast cancer in women with natural or artificially induced postmenopausal status whose disease has progressed following antiestrogen therapy. It is a new active substance introduced to the Canadian market on August 17, 2000. Its ATC classification is L028G06.
1.2 Aromasin 25 mg tablet (Aromasin - DIN 02242705) is being sold in Canada by Pharmacia Canada Inc. (Pharmacia).
1.3 Canadian Patent No. 1,319,680 pertains to Aromasin. This patent was granted to Pharmacia & Upjohn S.p.A on June 29, 1993 and will expire on June 29, 2010. Pharmacia is the Canadian patentee.
1.4 Health Canada issued a Notice of Compliance for Aromasin on August 17, 2000, the date on which Pharmacia began selling the medicine in Canada.
2.0 Application of the Guidelines:
2.1 The Staff of the Patented Medicine Prices Review Board have advised Pharmacia that, following the procedures outlined in the Board=s Guidelines for new medicines, Aromasin was classified as a category 3 new medicine. A Therapeutic Class Comparison (TCC) test was conducted using Femara (letrozole) and Arimidex (anastrozole) as comparable medicines of the same 4th level class of the Anatomical, Therapeutic, Chemical (ATC) System.
2.2 The results of the TCC indicated that the average selling price of Aromasin, $5.7243 per 25 mg tablet, during the period August 17, 2000 to December 31, 2000 appeared to exceed the maximum non-excessive (MNE) price of $4.9500 per 25 mg tablet by 15.6%. As a result, Pharmacia received revenues in excess of the Guidelines of $26,411.37 during that period.
2.3 An international price comparison (IPC) test was also conducted and showed that the Canadian price of Aromasin 25 mg tablet was the lowest among the PMPRB comparator countries and therefore did not exceed the Board's Guideline with respect to the highest international price.
2.4 The price review results for the period January 1, 2001 to December 31, 2001 showed that the average selling price of Aromasin, $5.3504 per tablet, continued to exceed the MNE price of $5.0738 per tablet by 5.5%. As a result, Pharmacia received revenues in excess of the Guidelines of $61,073.28 during that period.
2.5 The price review results for the period January 1, 2002 to December, 2002 showed that the average selling price of Aromasin, $4.9174 per tablet, was lower than the MNE price of $5.1826 per tablet by 5.2%. As a result, Pharmacia has offset the cumulative amount of revenues in excess of the Guidelines received in previous years.
3.0 Position of the Patentee:
3.1 This Voluntary Compliance Undertaking (VCU) constitutes no admission by Pharmacia that the price of Aromasin 25 mg tablet is or was excessive for purposes of the Patent Act.
3.2 Pharmacia is of the view that the drug product Megace (megestrol acetate) should have been included in the TCC of Aromasin conducted by Board Staff. Aromasin has been studied extensively in clinical trials in comparison to Megace.
3.3 Effective April 1, 2002, Pharmacia reduced the price of Aromasin 25 mg tablet to $4.95, a level within the Guidelines, and has provided public notification of this price reduction.
4.0 Terms of the VCU
4.1 Pharmacia undertakes to ensure that the average selling price of Aromasin 25 mg tablet will continue to be within the Board's Guidelines as long as it is under the jurisdiction of the Patented Medicine Prices Review Board.
Signature: Original signed by Amita Kent
Company Officer: Amita Kent
Position: Vice-President, Legal Affairs
Date: March 31, 2003