Launching New Drugs PMCQ Training Day

1. Launching New Drugs“A sense of urgency” October 19, 2004 Launching New DrugsPMCQ Training Day

2. Goals of the meeting • Broader perspective of new product launches • New reference data • Tools you can use tomorrow morning Launching New DrugsPMCQ Training Day

3. New Drug development timeline Launching New DrugsPMCQ Training Day

4. Course Outline • Introduction and Overview to need for new drugs • Maximizing resource utilization • Stepwise Process to Launching – Patrick McLean • The Approval Process - TPD – Micheline Ho • Using PAAB early – Ray Chepesiuk • Working Effectively with your Agency – Mark McElwain • Maximizing New Product Launch Effectiveness – Rose Schuett • Pricing and PMPRB – Joan McCormick Launching New DrugsPMCQ Training Day

5. Launching New DrugsPMCQ Training Day

6. Launching New Drugs“A sense of urgency” Launching New DrugsPMCQ Training Day

7. The Market Under Siege Generic erosion • In 2003, FDA approved 21 proprietary drugs and 362 generics • In the next five years, many proprietary drugs will be genericized: Statins Launching New DrugsPMCQ Training Day

8. A sense of urgency Quiz: “How long does it take for a generic co. to start shipping upon approval?” • ½ day • 30 days • 60 days • 90 days Launching New DrugsPMCQ Training Day

9. Surprise! Answer: • 1/2 day <<<<< • 30 days • 60 days • 90 days Launching New DrugsPMCQ Training Day

10. The Market Under Siege(cont’d) • Reimbursement pressures • Parallel trade in EU will be increased with the 2004 expansion – Eastern prices will migrate westward • Hungary instituted a new law in April, 2004 reducing all drug prices by 15% • UK pricing agreement ends in October – 6 or 10% on the table • US states are pushing for Canadian imports • Regulatory pressures • Pipelines are not robust • MOHs are being more discriminating • Vioxx, Prepulsid, Baycol, etc. Launching New DrugsPMCQ Training Day

11. How vulnerable is your company? Launching New DrugsPMCQ Training Day

12. Pharma Industry Dilemma • Topline sales declines make new products imperative, due to: - Generic erosion - Reimbursement reductions- Regulatory pressures • Development of new molecules is expensive • $867M to develop a NME • It can take 12-15 years from inception to launch • Only one in 5-10,000 compounds make it to market Launching New DrugsPMCQ Training Day

13. Pharma Industry Response • The Industry will NOT save its way to success – “bean counting” will only delay the inevitable… • The search for new molecules continues • Innovative new combination drugs provide new opportunities • Caduet – Lipitor + Norvasc • Lotrel – Lotensin + Norvasc • Vytorin – Zocor + Zetia • Symbyax – Zyprexa + Prozac Launching New DrugsPMCQ Training Day

14. Urgency and Precision • Time is money • How much money? For a $365M brand, each day delayed costs $1,000,000! • Precision is key- You never get a second chance to launch a new product – all you do is fix it! Launching New DrugsPMCQ Training Day

15. Time – the Great Paradox… “None of us ever has enough time, but each of us has all that there is…” Launching New DrugsPMCQ Training Day

16. Precision… “We can help…” Launching New DrugsPMCQ Training Day