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`Novo Nordisk will stop the once-weekly injectable semaglutide
`kidney outcomes trial, FLOW, based on interim analysis
`
`Bagsværd, Denmark, 10 October 2023 – Novo Nordisk today announced the decision to stop
`the kidney outcomes trial FLOW (Effect of semaglutide versus placebo on the progression of
`renal impairment in people with type 2 diabetes and chronic kidney disease).
`
`The decision to stop the trial is based on a recommendation from the independent Data
`Monitoring Committee (DMC) concluding that the results from an interim analysis met certain
`pre-specified criteria for stopping the trial early for efficacy.
`
`Based on the decision to stop the trial at interim, the process of closing the trial will be initiated.
`To protect the integrity of the trial, Novo Nordisk remains blinded to the results until trial
`completion. Novo Nordisk expects that FLOW will read out during the first half year of 2024.
`
`About FLOW
`FLOW is a randomised, double-blind, parallel-group, placebo-controlled, superiority trial
`comparing injectable semaglutide 1.0 mg with placebo as an adjunct to standard of care on
`kidney outcomes for prevention of progression of renal impairment and risk of renal and
`cardiovascular mortality in people with type 2 diabetes and chronic kidney disease (CKD). 3,534
`people are enrolled in the trial which has been conducted in 28 countries at more than 400
`investigator sites. The FLOW trial was initiated in 2019.
`
`The key objective of the FLOW trial is to demonstrate delay in progression of CKD and to lower
`the risk of kidney and cardiovascular mortality through the composite primary endpoint
`consisting of the following five components: onset of persistent ≥ 50% reduction in eGFR1
`according to the CKD-EPI2 equation compared with baseline, onset of persistent eGFR1 (CKD-
`EPI2) < 15 mL/min/1.73 m2, initiation of chronic kidney replacement therapy (dialysis or kidney
`transplantation), death from kidney disease or death from cardiovascular disease in people with
`type 2 diabetes and chronic kidney disease. Key secondary endpoints include annual rate of
`change in eGFR1 (CKD-EPI2), major adverse cardiovascular events (non-fatal myocardial
`infarction, non-fatal stroke, cardiovascular death) and all-cause death. The trial protocol
`provides for an interim analysis when a prespecified number of primary endpoint events has
`occurred.
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`Novo Nordisk A/S
`Investor Relations
`
`Novo Allé
`2880 Bagsværd
`Denmark
`
`Telephone:
`+45 4444 8888
`
`Internet:
`www.novonordisk.com
`
` CVR no:
`24 25 67 90
`Company announcement No 62 / 2023
`
`Novo Nordisk Exhibit 2017
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00001
`
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`About Ozempic®
`Once-weekly subcutaneous semaglutide is approved in 0.5, 1.0 and 2.0 mg doses under the
`brand name Ozempic® and indicated as an adjunct to diet and exercise to improve glycaemic
`control in adults with type 2 diabetes mellitus and to reduce the risk of major adverse
`cardiovascular events in adults with type 2 diabetes mellitus and established cardiovascular
`disease.
`
`Novo Nordisk is a leading global healthcare company, founded in 1923 and headquartered in Denmark. Our purpose is
`to drive change to defeat serious chronic diseases, built upon our heritage in diabetes. We do so by pioneering scientific
`breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease. Novo Nordisk
`employs about 59,000 people in 80 countries and markets its products in around 170 countries. Novo Nordisk's B
`shares are listed on Nasdaq Copenhagen (Novo-B). Its ADRs are listed on the New York Stock Exchange (NVO). For more
`information, visit novonordisk.com, Facebook, Instagram, X, LinkedIn and YouTube.
`
`Contacts for further information
`Media:
`
`Ambre James-Brown
`Elizabeth DeLuca (US)
`+45 3079 9289
`+1 609 580 9868
`abmo@novonordisk.com
`edel@novonordisk.com
`
`
`Investors:
`Daniel Muusmann Bohsen
`+45 3075 2175
`dabo@novonordisk.com
`
`David Heiberg Landsted
`+45 3077 6915
`dhel@novonordisk.com
`
`Frederik Taylor Pitter
`+45 3075 8259
`fptr@novonordisk.com
`
`
`1. eGFR: estimated glomerular filtration rate
`2. CKD-EPI: Chronic Kidney Disease Epidemiology Collaboration
`
`
`
`Jacob Martin Wiborg Rode
`+45 3075 5956
`jrde@novonordisk.com
`
`Sina Meyer
`+45 3077 6656
`azey@novonordisk.com
`
`
`
`
`Novo Nordisk A/S
`Investor Relations
`
`Novo Allé
`2880 Bagsværd
`Denmark
`
`Telephone:
`+45 4444 8888
`
`
`Internet:
`www.novonordisk.com
`CVR no:
`24 25 67 90
`Company announcement No 62 / 2023
`
`
`Novo Nordisk Exhibit 2017
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00002
`
`