Hitetrapib

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Hitetrapib Eliminating Heart Disease

• Gillian Brazier
• Development Head,
• Cardiovascular Medicine

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The Context

• Heart disease is the biggest killer in the
  western world.
• There is a huge medical need for better
  treatments for heart disease.
• A huge potential market exists for a better
  medicine than exists today.
• Statins are widely used but even so people suffer
  strokes and heart attacks.

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Mode of Action

• Atherosclerosis is due to build up of fatty
  deposits
• Statins reduce bad cholesterol
• Need also to increase good cholesterol
• Hitetrapib works in combination with a statin

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Phase II Trials

• Very good results.
• All patients had low HDL. Those on Hitetrapib
  showed an increase.
• Some also on a statin additionally showed a
  decrease in LDL
• Five patients experienced increased blood
  pressure and were taken off the trial. No proof
  that Hitetrapib caused this

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Phase III Trials

• Very expensive estimated 600 million
• 10,000 volunteers to be monitored for 3 years
• Difficult trial to design because of existing
  medications
• Risks
• Competitors drug failed spectacularly
• Combined therapy might not work
• There might be drug-drug interaction

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Market Considerations

• Need to be first to market
• If so, a blockbuster within three years
• Manufacture is relatively straightforward.
• Need to be first to the Regulators with this new
  type of therapy
• A life-saver. Good for company image
• Likely to be welcomed by health authorities

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Questions