Microsoft powerpoint - liraglutide lead 3 conference call presentation final.ppt

A focused healthcare company
Headline results from LEAD® 3 phase 3 study with liraglutide 11 December 2007, 17.00 CET, 16.00 UK time, 11.00 New York time • Introduction (Lars Rebien Sørensen, CEO) • LEAD® 3 results (Mads Krogsgaard Thomsen, CSO) • Overview of LEAD® programme (Mads Krogsgaard Forward-looking statements
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Factors that may affect future results include, but are not limited to, interest rate and currency exchange rate fluctuations, delay or failure of development projects, interruptions of supplies and production, product recall, pressure on insulin prices, unexpected contract breaches or terminations, government-mandated or market-driven price decreases for Novo Nordisk’s products, introduction of competing products, Novo Nordisk’s ability to successfully market current and new products, exposure to product liability and other legal proceedings and investigations, changes in reimbursement rules and governmental laws and related interpretation thereof, perceived or actual failure to adhere to ethical marketing practices, developments in international activities, which also involve certain political risks, investments in and divestitures of domestic and foreign companies and unexpected growth in costs and expenses.
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Novo Nordisk has the copyright on the information contained in this presentation. 2007 Novo Nordisk A/S.
Study design
Efficacy of liraglutide in monotherapy
Comparison with glimepiride:
• HbA1c level at the beginning of the study around 8.2%
• Statistically significantly greater HbA1c reduction
• more than 1% HbA1c reduction in whole group• more than 1.5% HbA1c reduction in diet failure patients • Statistically significant benefit of 3-4 kg on body weight• Statistically significant improvement in systolic blood Tolerability of liraglutide in monotherapy
• Liraglutide well-tolerated at both doses • Liraglutide associated with very low levels of hypoglycaemia (at the background level) in contrast to glimepiride treatment • Increase in cumulated level of mild to moderate nausea to 20- • Percentage of patients experiencing nausea in the low single digit range following the first three months Liraglutide phase 3 programme: LEAD®
Purpose of study
Comparator arms
Number of
subjects
LEAD 1: Effect of Liraglutide in
combination with sulfonylurea (glimepiride) b) TZD (rosiglitazone) LEAD 2: Effect of liraglutide in combination a) placebo
LEAD 3: Effect of liraglutide in
LEAD 4: Effect of liraglutide in combination placebo
LEAD 5: Effect of liraglutide in combination a) placebo
Concluding remarks and next steps
• All data packages ready for regulatory filing in the US and • Statistically significant benefit on HbA1c and body weight when compared to widely used classes of anti-diabetic drugs: • sulfonylurea, glitazone and basal insulin • Liraglutide well-tolerated across all study populations • e.g. hypoglycaemia, injection site reactions, antibody formation • Detailed results from the full LEAD® programme to be communicated at scientific conferences and published in • Phase 3b programme proceeding according to plans Investor information

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