Novo Nordisk A/S Class B · OMXCOP:NOVO_B
Novo Nordisk A/S Class B — Corporate Update (November 2012)
8 slides from Novo Nordisk A/S Class B's corporate update, Nov 9, 2012
Slide 1: Update on FDA Advisory Committee meeting on Tresiba and Ryzodeg
9 November 2012 Slide no 1 Update on FDA Advisory Committee meeting on Tresiba® and Ryzodeg® Update on FDA Advisory Committee meeting on Tresiba® and Ryzodeg® 9 November 2012
Slide 2: Agenda
Update on FDA Advisory Committee meeting on Tresiba® and Ryzodeg® 9 November 2012 Slide no 2 Agenda Introduction by Jesper Brandgaard, CFO Outcome of the Advisory Committee meeting by Mads Krogsgaard Thomsen, CSO Questions & answers
Slide 3: Forward-looking statements
Update on FDA Advisory Committee meeting on Tresiba® and Ryzodeg® 9 November 2012 Slide no 3 Forward-looking statements Novo Nordisk’s reports filed with or furnished to the US Securities and Exchange Commission (SEC), including this document as well as the company’s Annual Report 2011 and Form 20-F
Slide 4: FDA Advisory Committee meeting on 8 November 2012
Update on FDA Advisory Committee meeting on Tresiba® and Ryzodeg® 9 November 2012 Slide no 4 FDA Advisory Committee meeting on 8 November 2012 Overall focus: • Discussion of the safety and efficacy of insulin degludec and insulin degludec/insulin aspart for the treatment of Type 1 and Type 2 diabete
Slide 5: Voting question: Should a cardiovascular outcomes trial be conducted?
Update on FDA Advisory Committee meeting on Tresiba® and Ryzodeg® 9 November 2012 Slide no 5 Voting question: Should a cardiovascular outcomes trial be conducted for degludec and degludec/aspart? Vote Number Yes 12 No 0 Abstain 0 Total 12
Slide 6: Voting question: Has sufficient efficacy and safety data been provided?
Update on FDA Advisory Committee meeting on Tresiba® and Ryzodeg® 9 November 2012 Slide no 6 Voting question: Has sufficient efficacy and safety data been provided to support marketing of the products? Vote Number Yes 8 No 4 Abstain 0 Total 12
Slide 7: Next steps in US regulatory process for insulin degludec and degludec/aspart
Update on FDA Advisory Committee meeting on Tresiba® and Ryzodeg® 9 November 2012 Slide no 7 Next steps in US regulatory process for insulin degludec and insulin degludec/insulin aspart • Novo Nordisk will work closely with the FDA to resolve remaining issues necessary to complete the regulatory rev
Slide 8: Investor information
Update on FDA Advisory Committee meeting on Tresiba® and Ryzodeg® 9 November 2012 Slide no 8 Investor information Share information Investor Relations contacts Novo Nordisk’s B shares are listed on the stock exchange in Novo Nordisk A/S Copenhagen under the symbol ‘NOVO B’. Its ADRs are listed on In