Company Announcement
- Kesimpta® (ofatumumab) approved by U.S. FDA for the
treatment of relapsing forms of multiple sclerosis in
adults
- First B-cell therapy that can be self-administered
using Sensoready® autoinjector pen
- Approval based on Phase III ASCLEPIOS I and II
studies
Copenhagen, Denmark; August 20, 2020 –
Genmab A/S (Nasdaq: GMAB) announced today that the U.S.
Food and Drug Administration (U.S. FDA) has approved the use of
Kesimpta® (ofatumumab) injection for subcutaneous use, for the
treatment of relapsing forms of multiple sclerosis (RMS) in adults,
to include clinically isolated syndrome,
relapsing-remitting disease, and active secondary progressive
disease. Kesimpta is the first B-cell therapy that can be
self-administered by patients at home using the Sensoready®
autoinjector pen, once monthly after starting therapy. It is being
developed and marketed worldwide by Novartis under a license
agreement between Genmab and Novartis Pharma AG.
The approval was based on data from the Phase III 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 as well as the Phase II
APLIOS study, which determined the bioequivalence of the
subcutaneous delivery of ofatumumab via a pre-filled syringe and a
Sensoready pen in patients with RMS. The results from the ASCLEPIOS
studies were presented at the 35th Congress of the European
Committee for Treatment and Research in Multiple Sclerosis
(ECTRIMS) in September 2019 and were recently published in the
August 6, 2020 issue of The New England Journal of Medicine. In
December 2019 Novartis submitted the supplemental Biologics License
Application (sBLA) for this indication to the U.S. FDA.
“This is a significant day for patients in the U.S. with
relapsing multiple sclerosis, who will now have Kesimpta as an
efficacious and convenient treatment option. We would like to thank
the patients and investigators who took part in the trials that led
to this approval as well as Novartis for their collaboration and
their dedication, which has made ofatumumab available to an
entirely new population of patients in need,” said Jan van de
Winkel, Ph.D., Chief Executive Officer of Genmab.
Today’s news does not impact Genmab’s 2020 financial
guidance.
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 III 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 relapsing MS,
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 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 APLIOS The APLIOS study (NCT03560739) was
a 12-week, open-label, Phase II bioequivalence study to determine
the onset of B-cell depletion with ofatumumab subcutaneous monthly
injections and the bioequivalence of subcutaneous administration of
ofatumumab via a pre-filled syringe – as used in ASCLEPIOS I and II
– and a Sensoready pen in patients with RMS. 284 patients were
randomized according to injection device and site including the
abdomen and the thigh. B-cell depletion was measured nine times
over 12 weeks and Gd+ lesion counts were assessed at baseline and
at Weeks 4, 8 and 12.3
About Kesimpta® (ofatumumab)Ofatumumab is a
fully human CD20 monoclonal antibody (mAb) self-administered by a
once-monthly subcutaneous injection in development for relapsing
forms of multiple sclerosis (RMS). Kesimpta (ofatumumab) is
approved in the U.S. for the treatment of RMS in adults, to include
clinically isolated syndrome, relapsing-remitting disease, and
active secondary progressive disease, and is the first B-cell
therapy that can be self-administered at home by patients using a
Sensoready pen. Initial loading doses of Kesimpta are given on Days
1, 7 and 14, with the first injection performed under the guidance
of a healthcare provider. Ofatumumab works by binding to the CD20
molecule on the B-cell surface and inducing potent B-cell lysis and
depletion. 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, which affects approximately 2.5 million people
worldwide6, 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 Genmab Genmab is a publicly traded,
international biotechnology company specializing in the creation
and development of differentiated antibody therapeutics for the
treatment of cancer. Founded in 1999, the company is the creator of
the following approved antibodies: DARZALEX® (daratumumab, under
agreement with Janssen Biotech, Inc.) for the treatment of certain
multiple myeloma indications in territories including the U.S.,
Europe, Japan and China, Arzerra® (ofatumumab, under agreement with
Novartis AG), for the treatment of certain chronic lymphocytic
leukemia indications in the U.S., Japan and certain other
territories, Kesimpta (subcutaneous ofatumumab, under agreement
with Novartis AG), for the treatment of adults with relapsing forms
of multiple sclerosis in the U.S. and TEPEZZA® (teprotumumab, under
agreement with Roche granting sublicense to Horizon Therapeutics
plc) for the treatment of thyroid eye disease in the U.S. A
subcutaneous formulation of daratumumab, known in the U.S. as
DARZALEX FASPRO™ (daratumumab and hyaluronidase-fihj), has been
approved in the U.S. and Europe for the treatment of adult patients
with certain multiple myeloma indications. Daratumumab is in
clinical development by Janssen for the treatment of additional
multiple myeloma indications, other blood cancers and amyloidosis.
Genmab also has a broad clinical and pre-clinical product pipeline.
Genmab's technology base consists of validated and proprietary next
generation antibody technologies - the DuoBody® platform for
generation of bispecific antibodies, the HexaBody® platform, which
creates effector function enhanced antibodies, the HexElect®
platform, which combines two co-dependently acting HexaBody
molecules to introduce selectivity while maximizing therapeutic
potency and the DuoHexaBody® platform, which enhances the potential
potency of bispecific antibodies through hexamerization. The
company intends to leverage these technologies to create
opportunities for full or co-ownership of future products. Genmab
has alliances with top tier pharmaceutical and biotechnology
companies. Genmab is headquartered in Copenhagen, Denmark with
sites in Utrecht, the Netherlands, Princeton, New Jersey, U.S. and
Tokyo, Japan.
Contact:
Marisol Peron, Corporate Vice President, Communications &
Investor Relations T: +1 609 524 0065; E: mmp@genmab.com
For Investor Relations: Andrew Carlsen, Senior
Director, 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®. Arzerra®, Sensoready® and
Kesimpta® are trademarks of Novartis AG or its affiliates.
DARZALEX® and DARZALEX FASPRO™ are trademarks of Janssen
Pharmaceutica NV. TEPEZZA™ is a trademark of Horizon Therapeutics
plc.
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 ClinicalTrials.gov. A 12 Week Randomized Open Label
Parallel Group Multicenter Study to Evaluate Bioequivalence of 20
mg Subcutaneous Ofatumumab Injected by Pre-filled Syringe or
Autoinjector in Adult RMS Patients
https://clinicaltrials.gov/ct2/show/NCT03560739. Accessed May 20204
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 GlobalData. EpiCast Report: Multiple
Sclerosis - Epidemiology Forecast to 2026. Published November
2017.7 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. 36CVR no. 2102 3884LEI Code
529900MTJPDPE4MHJ122
Genmab A/SKalvebod Brygge 431560 Copenhagen VDenmark
- 200820_CA36_Kesimpta US Approval
Genesis Healthcare (NYSE:GEN)
Historical Stock Chart
From Apr 2024 to May 2024
Genesis Healthcare (NYSE:GEN)
Historical Stock Chart
From May 2023 to May 2024