Company Announcement
- Novartis
receives European approval for Kesimpta® (ofatumumab) for the
treatment of relapsing forms of multiple sclerosis in
adults
- Approval
follows positive opinion by European Committee for Medicinal
Products for Human Use (CHMP) in January 2021
- Approval
based on Phase 3 ASCLEPIOS I and II studies
- First and
only self-administered, targeted B-cell therapy for adult patients
with relapsing multiple sclerosis approved in Europe
Copenhagen, Denmark; March 30, 2021 –
Genmab A/S (Nasdaq: GMAB) announced today that the European
Commission (EC) has granted Novartis marketing authorization for
the use of Kesimpta® (ofatumumab) in the treatment of relapsing
forms of multiple sclerosis (RMS) in adults with active disease
defined by clinical or imaging features. The EC approval
follows a positive opinion issued for subcutaneous ofatumumab in
RMS by the CHMP of the European Medicines Agency (EMA) in January
2021. Kesimpta, which is developed and marketed worldwide by
Novartis under a license agreement between Genmab and Novartis
Pharma AG, is the first B-cell therapy that can be
self-administered once-monthly at home via the Sensoready®
autoinjector pen.
“We are extremely pleased that Kesimpta is now approved in both
Europe and in the U.S., providing RMS patients with a convenient,
efficacious and safe treatment option as demonstrated in the study
findings from the ASCLEPIOS trials. We are looking forward to the
launch of Kesimpta in the various European markets,” said Jan van
de Winkel, Ph.D., Chief Executive Officer of Genmab.
The approval was based on data from the Phase 3 ASCLEPIOS I and
II trials, which investigated the efficacy and safety of monthly
subcutaneous ofatumumab 20mg versus once daily oral teriflunomide
14mg in adults with RMS. The results from the ASCLEPIOS studies
were published in the August 6, 2020 issue of The New England
Journal of Medicine.
About ASCLEPIOSThe ASCLEPIOS I and II studies
(NCT02792218 and NCT02792231) are twin, identical design, flexible
duration (up to 30 months), double-blind, randomized, multi-center
Phase 3 studies evaluating the safety and efficacy of ofatumumab
20mg monthly subcutaneous injections versus teriflunomide 14mg oral
tablets taken once daily in adults with a confirmed diagnosis of
RMS1,2. The studies enrolled 1,882 patients with RMS, between the
ages of 18 and 55 years, with an Expanded Disability Status Scale
(EDSS) score between 0 and 5.51,2. The studies were conducted in
over 350 sites in 37 countries.
The primary endpoint of both studies was to demonstrate that
ofatumumab is superior to teriflunomide in reducing the frequency
of confirmed relapses as evaluated by the annualized relapse rate
(ARR) in patients treated up to 30 months1,2. Secondary endpoints
included time to disability progression confirmed at three and six
months respectively, confirmed disability improvement at six
months, gadolinium enhancing T1 lesions, number of new or enlarging
T2 lesions, serum levels of neurofilament light chain (NfL), and
rate of brain volume loss1,2. Safety and the pharmacokinetic
properties of ofatumumab were also all measured throughout the
treatment period1,2.
About Kesimpta® (ofatumumab)Ofatumumab is a
fully human CD20 monoclonal antibody. It is self-administered by a
once-monthly injection, delivered subcutaneously. Initial doses of
Kesimpta are given at Weeks 0, 1 and 2, with the first injection
performed under the guidance of a healthcare provider. It is
approved in the U.S. for the treatment of RMS, to include
clinically isolated syndrome, relapsing-remitting disease, and
active secondary progressive disease in adults. In Europe Kesimpta
is approved for the treatment of RMS in adults with active disease
defined by clinical or imaging features. Kesimpta is the first
B-cell therapy that can be self-administered at home by patients
using a Sensoready® pen. Ofatumumab works by binding to the CD20
molecule on the B-cell surface and inducing potent B-cell lysis and
depletion3. Ofatumumab is being developed and marketed worldwide by
Novartis under a license agreement between Genmab and Novartis
Pharma AG.
About Multiple SclerosisMultiple sclerosis (MS)
is a chronic inflammatory disease of the central nervous system
characterized by myelin destruction and axonal damage of the brain,
optic nerves and spinal cord4. MS disrupts the normal functioning
of the brain, optic nerves and spinal cord through inflammation and
tissue loss5. MS affects approximately 2.8 million people
worldwide6. Prevalence of MS is higher in the European and Americas
regions, with a prevalence of 133 out of 10,000 people in Europe
living with MS6. It is often characterized into the following
forms: primary progressive MS (PPMS) and relapsing forms of MS
(RMS), which includes relapsing-remitting MS (RRMS) and secondary
progressive MS (SPMS)7. Approximately 85% of patients initially
present with RMS8.
About GenmabGenmab is an international
biotechnology company with a core purpose to improve the lives of
patients with cancer. Founded in 1999, Genmab is the creator of
multiple approved antibody therapeutics that are marketed by its
partners. The company aims to create, develop and commercialize
differentiated therapies by leveraging next-generation antibody
technologies, expertise in antibody biology, translational research
and data sciences and strategic partnerships. To create novel
therapies, Genmab utilizes its next-generation antibody
technologies, which are the result of its collaborative company
culture and a deep passion for innovation. Genmab’s proprietary
pipeline consists of modified antibody candidates, including
bispecific T-cell engagers and next-generation immune checkpoint
modulators, effector function enhanced antibodies and antibody-drug
conjugates. The company is headquartered in Copenhagen, Denmark
with locations in Utrecht, the Netherlands, Princeton, New Jersey,
U.S. and Tokyo, Japan. For more information, please visit
Genmab.com.
Contact:
Marisol Peron, Senior Vice President, Global Investor Relations
& CommunicationsT: +1 609 524 0065; E: mmp@genmab.com
For Investor Relations: Andrew Carlsen, Senior
Director, Head of Investor RelationsT: +45 3377 9558; E:
acn@genmab.com This Company Announcement contains forward looking
statements. The words “believe”, “expect”, “anticipate”, “intend”
and “plan” and similar expressions identify forward looking
statements. Actual results or performance may differ materially
from any future results or performance expressed or implied by such
statements. The important factors that could cause our actual
results or performance to differ materially include, among others,
risks associated with pre-clinical and clinical development of
products, uncertainties related to the outcome and conduct of
clinical trials including unforeseen safety issues, uncertainties
related to product manufacturing, the lack of market acceptance of
our products, our inability to manage growth, the competitive
environment in relation to our business area and markets, our
inability to attract and retain suitably qualified personnel, the
unenforceability or lack of protection of our patents and
proprietary rights, our relationships with affiliated entities,
changes and developments in technology which may render our
products or technologies obsolete, and other factors. For a further
discussion of these risks, please refer to the risk management
sections in Genmab’s most recent financial reports, which are
available on www.genmab.com and the risk factors included in
Genmab’s most recent Annual Report on Form 20-F and other filings
with the U.S. Securities and Exchange Commission (SEC), which are
available at www.sec.gov. Genmab does not undertake any obligation
to update or revise forward looking statements in this Company
Announcement nor to confirm such statements to reflect subsequent
events or circumstances after the date made or in relation to
actual results, unless required by law. Genmab A/S and/or its
subsidiaries own the following trademarks: Genmab®; the Y-shaped
Genmab logo®; Genmab in combination with the Y-shaped Genmab logo®;
HuMax®; DuoBody®; DuoBody in combination with the DuoBody logo®;
HexaBody®; HexaBody in combination with the HexaBody logo®;
DuoHexaBody®; HexElect®; and UniBody®. Kesimpta® and Sensoredy® are
trademarks of Novartis AG or its affiliates.
1 ClinicalTrials.gov. Efficacy and Safety of Ofatumumab Compared
to Teriflunomide in Patients With Relapsing Multiple Sclerosis
(ASCLEPIOS I). https://clinicaltrials.gov/ct2/show/NCT02792218.
Accessed January 2020. 2 ClinicalTrials.gov. Efficacy and Safety of
Ofatumumab Compared to Teriflunomide in Patients With Relapsing
Multiple Sclerosis.(ASCLEPIOS II).
https://clinicaltrials.gov/ct2/show/NCT02792231. Accessed January
2020.3 Smith P, Kakarieka A, Wallstroem E. Ofatumumab is a
fully human anti-CD20 antibody achieving potent B-cell depletion
through binding a distinct epitope. Poster presentation at the
European Committee for Treatment and Research in Multiple Sclerosis
(ECTRIMS) Congress; September 14-17; 2016; London, UK.4 Guthrie E.
Multiple sclerosis: a primer and update. Adv Studies Pharm.
2007;4(11):313-3175 John Hopkins Medicine. Multiple sclerosis (MS).
https://www.hopkinsmedicine.org/neurology_neurosurgery/centers_clinics/multiple_sclerosis/conditions/index.html.
Accessed August 2019.6 Multiple Sclerosis International Federation.
Atlas of MS 2020-Mapping multiple sclerosis around the world.
Available from:
https://www.msif.org/wp-content/uploads/2020/10/Atlas-3rd-Edition-Epidemiology-report-EN-updated-30-9-20.pdf
(Last accessed: January 2021).7 Multiple sclerosis international
federation. Types of MS.
https://www.msif.org/about-ms/types-of-ms/. Accessed August 20198
Datamonitor. Multiple Sclerosis Treatment. Published August
2016.
Company Announcement no. 24CVR no. 2102 3884LEI Code
529900MTJPDPE4MHJ122
Genmab A/SKalvebod Brygge 431560 Copenhagen VDenmark
- 300321_CA24_Kesimpta EU Approval
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