Launching New Drugs PMCQ Training Day

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Launching New Drugs A sense of urgency
October 19, 2004
Launching New DrugsPMCQ Training Day
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Goals of the meeting

• Broader perspective of new product launches
• New reference data
• Tools you can use tomorrow morning

Launching New DrugsPMCQ Training Day
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New Drug development timeline
Launching New DrugsPMCQ Training Day
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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
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Launching New DrugsPMCQ Training Day
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Launching New Drugs A sense of urgency
Launching New DrugsPMCQ Training Day
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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
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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

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Surprise!

• Answer
• 1/2 day ltltltltlt
• 30 days
• 60 days
• 90 days

Launching New DrugsPMCQ Training Day
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The Market Under Siege (contd)

• 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
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How vulnerable is your company?
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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

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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

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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!

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Time the Great Paradox

• None of us ever has enough time, but each of us
  has all that there is

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Precision

• We can help

Launching New DrugsPMCQ Training Day