launching new drugs pmcq training day launching new drugs “a sense of urgency” october 19, 2004
TRANSCRIPT
Launching New Drugs
PMCQ Training Day
Launching New Launching New DrugsDrugs
“A sense of “A sense of urgency”urgency”October 19, 2004October 19, 2004
Launching New Drugs
PMCQ Training Day
Goals of the meetingGoals of the meeting
• Broader perspective of new Broader perspective of new product launchesproduct launches
• New reference dataNew reference data• Tools you can use tomorrow Tools you can use tomorrow
morningmorning
Launching New Drugs
PMCQ Training Day
New Drug development New Drug development timelinetimeline
Launching New Drugs
PMCQ Training Day
Course OutlineCourse Outline• Introduction and Overview to need for new drugsIntroduction and Overview to need for new drugs• Maximizing resource utilizationMaximizing resource utilization
o Stepwise Process to Launching – Patrick McLean Stepwise Process to Launching – Patrick McLean o The Approval Process - TPD – Micheline HoThe Approval Process - TPD – Micheline Hoo Using PAAB early – Ray ChepesiukUsing PAAB early – Ray Chepesiuko Working Effectively with your Agency – Mark Working Effectively with your Agency – Mark
McElwainMcElwaino Maximizing New Product Launch Effectiveness – Maximizing New Product Launch Effectiveness –
Rose SchuettRose Schuetto Pricing and PMPRB – Joan McCormickPricing and PMPRB – Joan McCormick
Launching New Drugs
PMCQ Training Day
Launching New Drugs
PMCQ Training Day
Launching New Launching New DrugsDrugs
“A sense of “A sense of urgency”urgency”
Launching New Drugs
PMCQ Training Day
The Market Under The Market Under SiegeSiege
Generic erosionGeneric erosion• In 2003, FDA approved In 2003, FDA approved
21 proprietary drugs 21 proprietary drugs and 362 genericsand 362 generics
• In the next five years, In the next five years, many proprietary drugs many proprietary drugs will be genericized: will be genericized:
Drug SalesPatent Loss
Pfizer Lipitor $9.0B 2006Merck Zocor $5.6B 2006BMS Pravachol $1.8B 2005Total at Risk
$16.4B
Statins
A sense of urgencyA sense of urgencyQuiz: “How long does it take for Quiz: “How long does it take for
a generic co. to start shipping a generic co. to start shipping upon approval?”upon approval?”
½ day ½ day 30 days30 days 60 days60 days 90 days90 days
Launching New DrugsPMCQ Training Day
Surprise!Surprise!
Answer:Answer: 1/2 day1/2 day <<<<< <<<<< 30 days30 days 60 days60 days 90 days90 days
Launching New DrugsPMCQ Training Day
Launching New Drugs
PMCQ Training Day
• Reimbursement pressuresReimbursement pressures– Parallel trade in EU will be increased with the 2004 Parallel trade in EU will be increased with the 2004
expansion – Eastern prices will migrate westwardexpansion – Eastern prices will migrate westward– Hungary instituted a new law in April, 2004 reducing Hungary instituted a new law in April, 2004 reducing
all drug prices by 15%all drug prices by 15%– UK pricing agreement ends in October – 6 or 10% on UK pricing agreement ends in October – 6 or 10% on
the tablethe table– US states are pushing for Canadian importsUS states are pushing for Canadian imports
• Regulatory pressuresRegulatory pressures– Pipelines are not robustPipelines are not robust– MOHs are being more discriminating MOHs are being more discriminating
• Vioxx, Prepulsid, Baycol, etc. Vioxx, Prepulsid, Baycol, etc.
The Market Under The Market Under SiegeSiege (cont’d)(cont’d)
Launching New Drugs
PMCQ Training Day
How vulnerable is your How vulnerable is your company?company?
Launching New Drugs
PMCQ Training Day
Pharma Industry Pharma Industry DilemmaDilemma
• 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 Drugs
PMCQ Training Day
Pharma Industry Pharma Industry ResponseResponse
• 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
Urgency and Urgency and PrecisionPrecision
• 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
Time – the Great Time – the Great Paradox…Paradox…
“None of us ever has None of us ever has enough time, but each of enough time, but each of us has all that there is…”us has all that there is…”
Launching New DrugsPMCQ Training Day
Precision…Precision…
“We can help…”We can help…”
Launching New DrugsPMCQ Training Day