ANNUAL REPORT 2021
LUNDBECK
ANNUAL REPORT 2021
= CONTENTS
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OUR SCIENCE AND
INNOVATION
Over the past year, we consistently
demonstrated leadership in the CNS
space through our unique approach to
science and innovation. It's an
approach rooted in our commitment to
persist in a challenging space, shaped
by our agile mindset and defined by our
bold vision of better lives for people
with brain diseases.
EXECUTING THE R&D STRATEGY
In 2021, Lundbeck advanced the R&D strategy established in
2020, sharpening our focus on leading-edge science, de-risking
and optimizing clinical development and supporting the
commercialization of truly global products.
Central to the approach of rebuilding the pipeline is the
utilization of an experimental medicine approach that allows us
to de-risk the pipeline and advance only the most promising
drug candidates into full development. We executed this
throughout the year and were able to initiate two important
studies: A phase II proof-of-concept study program of Lu
AF82422 for treatment of Multiple System Atrophy and a phase
Il proof-of-concept study of Lu AG09222 for migraine
prevention.
We also advanced our ambition to become a truly global
developmental organization, registering and launching VyeptiⓇ
in a number of markets.
Also in 2021, we established several important partnerships that
strengthen our developmental capabilities through external
innovation. In October 2021, we entered into an agreement with
the South Korean biopharmaceutical company AprilBio and
gained exclusive worldwide rights to APB-A1 (now Lu
AG22515), a phase-I-ready biotherapeutic for the treatment of
neuroimmune diseases. Lu AG22515 is a novel and well-
differentiated anti-CD40 ligand (CD40L) antibody-like drug
candidate. Modulating the CD40L/CD40 interaction holds great
promise for treatment of a wide range of immune-related
nervous system disorders. The agreement bolsters our
neuroinflammation/neuroimmunology discovery platform,
strengthening the biology cluster focus of our future therapies.
In August 2021, we entered a strategic research collaboration
with the U.S.-based company Rgenta Therapeutics to discover
small molecules targeting RNA regulation and splicing of
disease-causing genes. Lundbeck gained access to technology
that targets RNA pathways, and with this exciting platform we
aim to pursue novel targets previously inaccessible.
DEVELOPMENTAL PIPELINE
We believe that what fuels innovative drug discovery is a focus
on the most promising science - to be in touch with and at the
leading edge of where the neuroscience field is headed in our
understanding of the brain and the pathophysiology that
underpins brain health.
Through pursuit of novel targets within the four biological
clusters upon which we are focused, we are advancing truly
innovative solutions to areas of significant unmet need in brain
diseases.
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HORMONAL / NEUROPEPTIDE SIGNALING
Eptinezumab- development and regulatory status
Eptinezumab is a monoclonal antibody (mAb) that binds to the
calcitonin gene-related peptide (CGRP), a neuropeptide
believed to play a key role in mediating and initiating migraine,
with high specificity and potency. Eptinezumab is administered
as a quarterly 30-minute intravenous (IV) infusion, providing
immediate and complete bioavailability.
In February 2020, VyeptiⓇ (eptinezumab) was approved by the
FDA as the first FDA-approved IV treatment for the treatment of
migraine in adults. The recommended dose is 100 mg every 3
months; some patients may benefit from a dose of 300 mg.
Eptinezumab was subsequently approved in the U.A.E. in
December 2020, Canada in January 2021, Kuwait in May 2021,
Australia in June 2021, Singapore in September 2021 and
Switzerland in October 2021.View entire presentation