Price Reduction for Fasturtec

OTTAWA, June 30, 2004: The Patented Medicine Prices Review Board has concluded proceedings commenced in May in regard to the medicine Fasturtec by accepting a Voluntary Compliance Undertaking (VCU) by Sanofi-Synthelabo Canada Inc. (Sanofi). Under the terms of the VCU, Sanofi shall lower the price of Fasturtec from $295.00 per vial to about $125.00 per vial, effective by July 26, 2004.

The price reduction is consistent with the PMPRB's Price Guidelines which limit the introductory price of this drug to the median of the prices in seven other countries. Under the Guidelines, future price increases for Fasturtec will be limited to increases in the Consumer Price Index (CPI). Also, to offset excess revenues from past sales of Fasturtec, Sanofi will provide rebates directly to the 28 hospitals that purchased Fasturtec in the past at the higher price.

On May 20, 2004, the Board issued a Notice of Hearing pertaining to the allegations of Board Staff that Fasturtec was being sold by Sanofi at prices exceeding the Guidelines. A pre-hearing conference had been scheduled for July 6 and the matter was scheduled to be heard by the Board commencing on August 23. On June 25, 2004, Sanofi filed a VCU negotiated with Board Staff to resolve the issues raised by the Notice of Hearing. Both made submissions supporting approval of the VCU.

In its submission, Board Staff noted that Sanofi intends to maintain a list price for Fasturtec which is substantially higher than the reduced price, despite its undertaking that no customer in Canada would pay a price higher than the reduced price. As this may raise a novel issue, Board Staff has recommended to the Board that it initiate a policy review. The Board will report further on this matter in the fall.

Fasturtec has been sold to hospitals in Canada under Health Canada's Special Access Program since May 21, 2002. It is indicated for the treatment and prevention of hyperuricemia in paediatric and adult cancer patients. It is administered intravenously.

The documents are available on the PMPRB website or by contacting the Secretary of the Board.

The PMPRB is an independent quasi-judicial tribunal created under the Patent Act. The PMPRB protects consumer interests and contributes to Canadian health care by ensuring that prices charged by manufacturers of patented medicines are not excessive.

For further information:

Sylvie Dupont, Secretary of the Patented Medicine Prices Review Board

Toll-free #: 1 877 861-2350 – Direct line: (613) 954-8299 – E-mail:

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