Hitetrapib – Eliminating Heart Disease Gillian Brazier Development Head, Cardiovascular Medicine

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.

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

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

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: – Competitor’s drug failed spectacularly – Combined therapy might not work – There might be drug-drug interaction

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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