Voluntary Compliance Undertaking of Baxter Corporation to the Patented Medicine Prices Review Board

December 12, 2012

1 Product Summary

Procytox

1.1 Procytox (cyclophosphamide) is indicated for the treatment of frequently responsive myeloproliferative and lymphoproliferative disorders, frequently responsive solid malignancies and malignant neoplasms of the lung.

1.2 Patent CA 2,301,104, the last patent pertaining to Procytox, was granted on October 20, 2009 to Baxter International Inc. and Baxter Healthcare SA and lapsed on August 14, 2012. Baxter Corporation (Baxter) is the patentee for purposes of the PMPRB.

1.3 On February 4, 2002, Health Canada issued Notices of Compliance to Baxter for Procytox. Procytox is available in six dosage forms: 25mg/tab (DIN 02241795), 50mg/tab (DIN 02241796), 200mg/vial (DIN 02241797), 500mg/vial (DIN 02241798), 1000mg/vial (DIN 02241799) and 2000mg/vial (DIN 02241800). Sales for Procytox tablets and vials by Baxter began on January 1, 2003. Procytox was previously sold by another company.

Uromitexan

1.4 Uromitexan (mesna) is indicated for the reduction and prevention of urinary tract toxicity (hemorrhagic cystitis) of oxazaphosphorines.

1.5 Patent CA 2,107,961, the last patent pertaining to Uromitexan, was granted on March 25, 2003 and lapsed on October 9, 2012. At the time of lapse, patent CA 2,107,961 was owned by Baxter International Inc. and Baxter Healthcare SA. Baxter is the patentee for purposes of the PMPRB.

1.6 On February 4, 2002, Health Canada issued a Notice of Compliance to Baxter for Uromitexan 100mg/mL (DIN 02241411). Uromitexan was first sold by Baxter on November 1, 2002. Another Notice of Compliance was issued for Uromitexan 100mg/mL (DIN 02371839) on August 25, 2011 and sales by Baxter of that product began on April 13, 2012. Uromitexan was previously sold by another company.

Ifex

1.7 Ifex (ifosfamide) is indicated as first-line single agent therapy or second-line single agent therapy in patients who have failed to respond or who have relapsed on other chemotherapeutic regimens in the treatment of soft tissue sarcoma. Ifex is also indicated as second-line single agent therapy in patients who have failed to respond or who have relapsed on other chemotherapeutic regimens in the treatment of pancreatic carcinoma. Ifex is indicated as well as a single agent or in combination with cisplatin and bleomycin in advanced or recurrent disease in cervical carcinoma.

1.8 Patent CA 2,301,104, the last patent pertaining to Ifex, was granted on October 20, 2009 to Baxter International Inc. and Baxter Healthcare SA and lapsed on August 14, 2012. Baxter is the patentee for purposes of the PMPRB.

1.9 On February 4, 2002, Health Canada issued Notices of Compliance to Baxter for Ifex 1000mg/vial (DIN 02241357) and Ifex 3000mg/vial (DIN 02241356). Ifex 1000mg/vial was first sold by Baxter on January 1, 2003. Ifex 3000mg/vial was first sold by Baxter on November 1, 2002. Ifex was previously sold by another company.

2 Application of Excessive Price Guidelines

2.1 In accordance with the Board's Guidelines, Board Staff conducted a Therapeutic Class Comparison (TCC) test and an International Price Comparison (IPC) test for all DINs of Procytox. Excess revenues accumulated from the time the investigations for all DINs were triggered to August 14, 2012, the patent lapse date, are $6,520,381.87.

2.2 In accordance with the Board's Guidelines, Board Staff conducted a Median International Price Test (MIPC) test for Uromitexan 100mg/mL (DIN 02241411) as no comparable products were identified. Uromitexan (DIN 02371839) was classified as a Slight/No improvement drug product. A Reasonable Relationship (RR) test against Uromitexan 100mg/mL (DIN 02241411) and an IPC test were conducted. Excess revenues accumulated from the time the investigations for both DINs were triggered to October 9, 2012, the patent lapse date, are $5,834,001.29.

2.3 In accordance with the Board's Guidelines, Board Staff conducted a TCC test and an IPC test for Ifex. Excess revenues accumulated from the time the investigations for both DINs were triggered to August 14, 2012, the patent lapse date, are $3,403,234.33.

3 Position of the Patentee

3.1 This Voluntary Compliance Undertaking (VCU) constitutes no admission by Baxter that the prices of Procytox, Uromitexan or Ifex are or were excessive for purposes of the Patent Act.

4 Terms of the Voluntary Compliance Undertaking

4.1 In order to comply with the Guidelines, Baxter undertakes as follows:

4.1.1 To make payments to Her Majesty in right of Canada in the amounts of $6,520,381.87 for the Procytox DINs, $5,834,001.29 for the Uromitexan DINs and $3,403,234.33 for the Ifex DINs, within 30 days of the acceptance of this VCU.

4.1.1 To notify the PMPRB in the event that other patents pertaining to Procytox, Uromitexan or Ifex are issued in any future period.

Original signed by:

Name: Michael Oliver

Position: General Manager, Canada

Patentee: Baxter Corporation

Date: December 12, 2012

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