Risperdal Consta VCU and PMPRB Updates

Greetings,

We would like to update you on new items related to the PMPRB.

1. Board approves Janssen-Ortho’s Voluntary Compliance Undertaking (VCU) for Risperdal Consta:

• The agreed upon 2004 and 2005 MNEs were 50% higher than the MNE's in the original statement of allegations.
• Janssen-Ortho Inc has agreed to pay the Board $4.39m for revenues received (3 DINs) September 04 to December 06.
• Janssen maintains the drug is improperly categorized as category- 3 (me-too) because it offers substantial improvements.

• Board will "permit manufacturers to exclude, from the calculation of the price of a medicine for price review purposes, products supplied under a compassionate release program during 2007." (Communique May 2007)
• This amends the statement in the April 2007 NEWSletter with respect to the inclusion of compassionate programs. The Communiqué did not mention rebates to provinces ( e.g. Bill 102/ 130).
• Board will continue to consider the implications of Dovobet and will consult on possible changes
Clients are encouraged to contact Brogan for further discussion regarding the upcoming PMPRB data filing.

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• Quadracel & Pentacel (Sanofi Pasteur Limited) pre-hearing Conference June 25
• Penlac Nail Laquer (Sanofi-Aventis Canada Inc.) hearing July 23-27
• Copaxone (Teva Neuroscience) hearing June 27
• Concerta (Janssen-Ortho Inc.) hearing June 11-12