Novo gets shot in the arm from semaglutide

Novo Nordisk does not look ready to give up its diabetes crown anytime soon. Data from a second pivotal trial of its once-weekly injectable semaglutide should help the company protect its GLP-1 franchise, which has been hit by increasing competition.

There are four more pivotal trials to read out but the latest, Sustain 3, against AstraZeneca’s Bydureon, was seen as one of the most important. This and the other studies in the 8,000-patient Sustain programme, reporting between now and early 2016, will help establish semaglutide’s commercial potential – and for now things are looking good (see table below).

Novo separately got FDA approval for Tresiba, its next-generation insulin analogue, and companion product Ryzodeg – the positive decision had been expected by analysts, but is still a relief. Tresiba’s label is, as had been expected, with no clear-cut superiority claims over Sanofi’s Lantus.

These events helped drive Novo’s share price up 3% on Friday.

Semaglutide vs Bydureon

The latest semaglutide results come after the first pivotal trial, Sustain 1, reported positive data in July (Novo Sustains momentum with first weekly GLP-1 data, July 13, 2015). 

Since then analyst forecasts have been creeping up: consensus now stands at $962m in 2020, from $598m at the start of 2015.

Expectations could rise even further with the new study. While Sustain 1 tested the weekly injection against placebo in treatment-naive patients, making it relatively easy to show a benefit, Sustain 3 is a better indication of semaglutide’s promise in the real world.

In the 56-week long trial, Novo’s project or Astra’s Bydureon, another once-weekly GLP-1 agonist, were given on top of one to two other oral antidiabetics, specifically metformin and/or thiazolidinedione and sulfonylureas.

From a mean baseline glycated haemoglobin (HbA1C) of 8.4%, semaglutide lowered levels by 1.5 percentage points, compared with a 0.9-point drop in those taking Bydureon – a statistically significant difference.

In addition, 66% of patients in the semaglutide group achieved a target of HbA1C levels of below 7%, versus 40% in the Bydureon group. Semaglutide-treated patients also had significantly greater weight loss than those on Astra’s drug.

Victoza successors

Bank of America Merrill Lynch analysts give semaglutide an 80% chance of approval. If the project does get the go-ahead this will take some pressure off Novo’s daily injection Victoza, the number-one GLP-1 agonist, which has lost market share in recent years to newer products like Lilly’s once-weekly Trulicity.

Further into the future, the injectable version of semaglutide might be superseded by Novo’s oral semaglutide, which promises even greater convenience, and will soon to enter phase III (Novo’s oral GLP-1 looks sweeter, August 27, 2015). 

For now Novo’s future in diabetes is looking brighter with the Sustain 3 data; the next hurdle is to show similarly impressive results with the rest of the programme. The Sustain 6 cardiovascular outcomes study could be particularly tricky.

Study Enrolment Trial ID Setting
Sustain 1 387 NCT02054897 vs placebo in treatment naïve patients
Sustain 2 1,200 NCT01930188 vs Januvia as an add-on to metformin and/or TZD
Sustain 3 813 NCT01885208 vs Bydureon as add-on to 1-2 oral antidiabetic drugs
Sustain 4 1,089 NCT02128932 vs Lantus as add-on to metformin, with or without sulfonylurea in insulin-naïve patients
Sustain 5 397 NCT02305381 vs placebo as an add-on to basal insulin, with or without metformin
Sustain 6 3,297 NCT01720446     Long-term cardiovascular outcomes trial

To contact the writer of this story email Madeleine Armstrong in London at [email protected] or follow  @medtech_ma on Twitter

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