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Microsoft powerpoint - liraglutide lead 3 conference call presentation final.pptA 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
The above contains forward-looking statements as the term is defined in the US Private Securities Litigation Reform Act of 1995. This in particular relates to information included under the headings ‘Outlook 2007’, ‘Research and development update’ and ‘Legal issues update’ with reference to plans, forecasts, expectations, strategies, projections and assessment of risks. Words such as ‘believe’, ‘expect’, ‘may’, ‘will’, ‘plan’, ‘strategy’, ‘prospect’, ‘foresee’, ‘estimate’, ‘project’, ‘anticipate’, ‘can’, ‘intend’ and similar words identify Examples of such forward-looking statements include, but are not limited to: (i) statements of plans, objectives or goals for future operations including those related to Novo Nordisk’s products, product research, product introductions and product approvals as well as co-operations in relation thereto, (ii) statements containing projections of revenues, income (or loss), earnings per share, capital expenditures, dividends, capital structure or other net financials, (iii) statements of future economic performance and (iv) statements of the assumptions underlying or relating to such statements.
These statements are based on current plans, estimates and projections, and therefore undue reliance should not be placed on them. Moreover, such statements are not guarantees of future results. By their very nature, forward-looking statements involve inherent risks and uncertainties, both general and specific, and risks exist that the predictions, forecasts, projections and other forward-looking statements will not be achieved. Novo Nordisk cautions that a number of important factors could cause actual results to differ materially from the plans, objectives, expectations, estimates and intentions expressed in such forward-looking statements.
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.
Risks and uncertainties are further described in reports filed by Novo Nordisk with the US Securities and Exchange Commission (SEC), including the company’s Form 20-F for 2006 filed in February 2007, and in the section ‘Risk management’ of the Annual Report 2006 Forward-looking statements speak only as of the date they were made, and unless required by law Novo Nordisk is under no duty and undertakes no obligation to update or revise any of them, after the distribution of this Stock Exchange Announcement, whether as a result of new information, future events or otherwise.
Novo Nordisk has the copyright on the information contained in this presentation. 2007 Novo Nordisk A/S.
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
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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