Genmab Announces Plan to Transition Arzerra® (ofatumumab) to an Oncology Access Program for Chronic Lymphocytic Leukemia Pat...
August 20 2020 - 4:06PM
Company Announcement
- Novartis intends to transition availability of Arzerra®
(ofatumumab) to an oncology access program for chronic lymphocytic
leukemia patients in the U.S.
- Genmab receives USD 30 million from Novartis as payment
for lost potential royalties and improves 2020 financial
guidance
Copenhagen, Denmark; August 20, 2020 –
Genmab A/S (Nasdaq: GMAB) announced today that Novartis
intends to transition availability of Arzerra® (ofatumumab) to an
oncology patient access program that will provide Arzerra at no
cost to chronic lymphocytic leukemia (CLL) patients in the
U.S. This program will be facilitated through the Patient
Access Novartis Oncology (PANO). As a consequence, Novartis will
pay Genmab a lump sum of USD 30 million as payment for lost
potential royalties. Arzerra was developed by Novartis under a
license agreement between Genmab and Novartis Pharma AG.
“We are pleased that patients with CLL who have benefitted from
Arzerra can remain on treatment via Novartis’ patient access
program,” said Jan van de Winkel, Ph.D., Chief Executive Officer of
Genmab.
Genmab is also improving its 2020 financial guidance last
published on August 12, 2020, due to the inclusion of the payment
from Novartis.
OUTLOOK
MDKK |
Revised Guidance |
Previous Guidance |
Revenue |
9,250 – 9,850 |
9,100 - 9,700 |
Operating expenses |
(3,850) - (3,950) |
(3,850) - (3,950) |
Operating income |
5,350 – 5,950 |
5,200 - 5,800 |
About Ofatumumab
(Arzerra®)Ofatumumab is a human
monoclonal antibody that is designed to target the CD20 molecule
found on the surface of normal B lymphocytes and on B cell
malignancies (including chronic lymphocytic leukemia).
In more than 60 countries worldwide, including the United States
and EU member countries, Arzerra was approved as monotherapy for
the treatment of patients with CLL who are refractory after prior
treatment with fludarabine and alemtuzumab. In the United States,
Arzerra was also approved for use in combination with chlorambucil
for the treatment of previously untreated patients with CLL for
whom fludarabine-based therapy is considered inappropriate, in
combination with fludarabine and cyclophosphamide for the treatment
of patients with relapsed CLL, for extended treatment of patients
who are in complete or partial response after at least two lines of
therapy for recurrent or progressive CLL and as monotherapy for the
treatment of patients with CLL refractory to fludarabine and
alemtuzumab. In the European Union, Arzerra was approved for use in
combination with chlorambucil or bendamustine for the treatment of
patients with CLL who have not received prior therapy and who are
not eligible for fludarabine-based therapy and in combination with
fludarabine and cyclophosphamide for adult patients with relapsed
CLL. On January 22, 2018, it was announced that Novartis would
transition Arzerra for the treatment of CLL indications from
commercial availability to limited availability via compassionate
use programs in markets outside of the U.S. and Japan.
Subsequently, on August 7, 2020, it was announced that Novartis
would transition availability of Arzerra in the U.S. to an oncology
access program. Novartis obtained rights for ofatumumab from Genmab
in all indications in December 2015.
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 and Japan, 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 as
DARZALEX FASPRO™ (daratumumab and hyaluronidase-fihj) in the U.S.,
has been approved in the U.S. and Europe for the treatment of adult
patients with certain multiple myeloma indications. The first
approved Genmab created therapy, Arzerra® (ofatumumab, under
agreement with Novartis AG), approved for the treatment of certain
chronic lymphocytic leukemia indications, is available in Japan and
is also available in other territories via compassionate use or
oncology access programs. 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® 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.
Company Announcement no. 37CVR no. 2102 3884LEI Code
529900MTJPDPE4MHJ122
Genmab A/SKalvebod Brygge 431560 Copenhagen VDenmark
- 200820_CA37_Arzerra Update
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