This article is part of an ongoing blog series profiling the12 new, game-changing drugs predicted to achieve blockbuster status by 2022 in the 2018 edition of Drugs to Watch, the annual industry forecast and analysis from Clarivate Analytics. Read the full Drugs to Watch report here or follow the series for the latest updates.
Drugs to Watch, the annual industry forecast and analysis report from Clarivate Analytics, was published in March 2018, detailing pharma’s expected blockbuster launches for 2018. Among the 12 drugs forecast to be a blockbuster by 2022 there was one drug which also featured in Clarivate’s Drugs to Watch report in 2017. Novo Nordisk’s GLP-1 inhibitor Ozempic (semaglutide), indicated for type 2 diabetes, has featured twice as it had been expected to launch in 2017 but a late approval delayed U.S. launch until February 2018.1
Of the 12 expected blockbuster launches for 2018, Novo Nordisk’s Ozempic is the only drug also featured in Clarivate’s Drugs to Watch 2017 report.
GLP-1 analogs are important in the treatment of type 2 diabetes as they have shown greater glucose-lowering and weight loss efficacy than existing drugs. Available to date as injectable formulations, once-daily Victoza (also from Novo Nordisk) leads the market, although the convenience of newer once-weekly options is a strong advantage, notably Lilly’s Trulicity. Demonstration of cardiovascular risk reduction for Victoza (LEADER trial2) is strengthening its position in the short term, however, with cardiovascular outcomes data from the REWIND trial for Trulicity expected by the end of 20183, and launch of an oral formulation of Ozempic expected in 20204, the dynamics of the GLP-1 market are expected to disrupt materially in the medium term.
Ozempic, which is dosed once a week subcutaneously, was approved based on the six-trial SUSTAIN program, which demonstrated superiority in blood glucose and weight control versus existing options, including Januvia (sitagliptin), Bydureon (controlled-release exenatide) and Lantus (insulin glargine).5 Like Victoza, Ozempic has positive effects on cardiovascular outcomes, reducing stroke risk by 39% and myocardial infarction risk by 26%.6 Despite a further approval, in Japan in late March 20187, Cortellis Consensus Sales Forecasts (source Thomson Reuters I/B/E/S) have moderated slightly since the Drugs to Watch 2018 report was published, dropping from $260 million in 2018 to $219 million for 2018. However, longer-term forecasts have risen from $3.469 billion for 2022 to $3.662 billion, likely based on firming analyst opinion on oral semaglutide.
Like Victoza, Ozempic has positive effects on cardiovascular outcomes, reducing stroke risk by 39% and myocardial infarction risk by 26%.6
Highly anticipated first phase III data were reported for oral semaglutide in February 2018. PIONEER 1, the first of a 10-trial phase III program for the drug, showed the three doses tested improved glucose control versus placebo. Additionally, the highest dose demonstrated superior weight loss, and when only including patients who adhered to the treatment regimen, all dosages improved weight loss.8 Concern remains on levels of nausea associated with treatment, and patients cannot eat for 30 minutes after administration, which may temper uptake. However, the fact that patients will be more inclined to incorporate oral therapy earlier in their treatment is likely to be strongly favored by prescribers seeking adjunctive treatment options in patients failing standard first-line treatment (metformin). The combined Cortellis Consensus Forecast data for the semaglutide franchise, including Ozempic and oral semaglutide, currently stand at $4.925 billion for 2022. Data from the full PIONEER program are expected to be fully reported by the end of 2018.9