Novo Nordisk Annual Report 2021
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Contents
Introducing Novo Nordisk
Strategic Aspirations
Key risks
Management
Consolidated statements
Additional information.
Novo Nordisk Annual Report 2021 26
Nadia Sadi is living with non-alcoholic
steatohepatitis (NASH) in Denmark
WegovyⓇ, once-weekly subcutaneous semaglutide 2.4 mg, takes
the medical treatment of obesity to a new level, as an adjunct to
diet and exercise, with an average sustained weight loss from
baseline of 17-18%4 sustained over 68 weeks in clinical trials.
The implications of such weight loss can be profound since
people with obesity face a range of health risks, from cancer,
type 2 diabetes and heart disease, to severe symptoms and
complications of COVID-19.
Our ultimate aspiration is to close the gap between current
pharmacological treatment options and bariatric surgery through
combination therapies. This work will take a significant step
forward next year with the planned initiation of a large phase 3
4. Based on the trial product estimand (secondary statistical approach): treatment effect
if all people adhered to treatment and did not initiate other anti-obesity therapies.
When using a treatment policy estimand, 15-17% weight loss was reported
study looking at a combination of cagrilintide and semaglutide.
Cagrilintide, a long-acting amylin analogue, works by reducing the
signaling of hunger to the brain, and early phase 1b data suggests
that its combination with semaglutide provides additive weight loss
efficacy without compromising gastrointestinal tolerability.
Alongside this, we have initiated a phase 3 trial of high-dose
semaglutide 50 mg as an oral treatment for obesity. This would
offer patients a new option and could potentially address issues
associated with injections.
Innovating in rare diseases
The rare blood and endocrine disorders that our Biopharm
business seeks to treat are areas of continuing high unmet
need, and we are advancing several key new products in
our pipeline. This includes the planned initiation of phase
3 development of Mim8, a next-generation subcutaneous
prophylactic treatment for haemophilia A, in 2022. We are also
awaiting the results from phase 3 trials with concizumab in
patients with haemophilia A or B, with or without inhibitors,
while a phase 3 trial investigating the efficacy and safety of
concizumab for pediatric use is expected to be initiated in 2022.
Furthermore, we are seeking to harness disruptive technologies
such as gene editing and RNA interference to develop next-
generation treatments for rare diseases. In December, we
announced the completion of the acquisition of Dicerna
Pharmaceuticals - a Boston-based biotech firm specialising
in RNAi therapeutics for rare and common diseases. The
acquisition builds on a successful collaboration initiated with
Dicerna in 2019 to discover and develop selective gene-silencing
therapies for liver-related cardio-metabolic diseases using
Dicerna's proprietary RNAi technology platform, and we will now
seek to expand the application of this innovative technology
across all our therapy areas.
Broadening our horizons across serious chronic diseases
We are actively widening our therapeutic focus as we explore
a more holistic approach to cardiometabolic diseases - a
trend exemplified by the potential of semaglutide to improve
outcomes in a wide range of disorders.
Significantly, the push into new areas includes the treatment of
Alzheimer's disease, where we are testing oral semaglutide 14
mg in two phase 3a trials that will run for three years. We have
also started a phase 3 programme with semaglutide in patients
with NASH, while two major phase 3 trials are exploring the
potential of semaglutide in treating heart disease.
Beyond semaglutide, our antibody drug ziltivekimab has
entered phase 3 development for atherosclerotic cardiovascular
disease and we are exploring a novel oral PCSK9i agent for
high cholesterol in phase 2. Meanwhile, new partnerships with
Prothena and Heartseed have strengthened our pipeline in
cardiovascular disease, with the latter building our expertise in
the exciting new field of cell therapy.
Strategic Aspirations
2025 Innovation and
therapeutic focus
- Further raise the innovation-bar for diabetes treatment
- Develop a leading portfolio of superior treatment
solutions for obesity
- Strengthen and progress the Biopharm pipeline
- Establish presence in other serious chronic diseases
focusing on Cardiovascular disease (CVD); Non-alcoholic
steatohepatitis (NASH)View entire presentation