PMPRB Newsletter Summary

• "Board is continuing with its assessment..." No dates set for next steps.

Hearings Completed:

• Adderall XR (Shire Canada) - Board Order posted

Hearings Against Generic Companies - Failure to File:

• Apotex Inc. - Decision made on preliminary matters from October 6. Decision not yet posted on website.
• ratiopharm Inc. - this matter is on hold based on request to consolidate this matter with ratio-Salbutamol.

Current Hearings:

• Apo-Salvent (Apotex) - ratiopharm Inc. was granted intervener status. Decision is posted on website. Nicoderm (sanofi-aventis) - proceedings resume November 21.
• Nicoderm (sanofi-aventis) - proceedings resume November 21.
• Penlac (sanofi-aventis) - set to resume on December 8
• Quadracel-Pentacel (sanofi pasteur) - set to resume November 25-27 and the final session is January 5-7, 2009.
• ratio-Salbutamol (ratiopharm Inc.) - pre-hearing conference held. Decision to be made in the next few weeks.
• Strattera (Eli Lilly) - Hearing resumes on January 27, 2009.

Judicial Reviews related to Hearings:

• Copaxone (Teva Neuroscience) - requested Judicial Review of Board's Decision and Order. Hearing date has not been scheduled.
• Nicoderm (sanofi-aventis) - there is a Judicial Review of the Board's decision to continue the hearing. No hearing date for the Judicial Review has been scheduled.

HDAP 2009 Schedule:

• 2009 meetings will be February 19, May 15, September 17, November 19
• Product monograph or similar information is due 3 months before the meeting; seven copies of the submission are due 2 months before meeting.

New Drug Reviews:

• Lucentis - neovascular (wet) age-related macular degeneration - category 2 - no comparators [Note this is the 3rd category 2 in conditions related to macular degeneration after Macugen & Visudyne]

NPDUIS Update:

• Two projects are nearing completion: New Drug Pipeline Monitor (2nd edition) will be posted in November 2008; Guidelines for Forecasting Program Expenditure for Canadian Public Drug Plans will be published in early 2009.