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Genmab — Capital/Financing Update 2015
Dec 9, 2015
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Download source fileCompany Announcement
-- Genmab to receive USD 5 million milestone payment from Janssen
-- Milestone triggered by progress in the Phase II study of daratumumab in
non-Hodgkin’s lymphoma (NHL)
-- This is the first milestone in the collaboration with Janssen outside of
Multiple Myeloma
Copenhagen, Denmark; December 9, 2015 – Genmab A/S (Nasdaq Copenhagen: GEN)
announced today it has reached a USD 5 million milestone in its daratumumab
collaboration with Janssen Biotech, Inc. (Janssen). The milestone payment was
triggered by progress in the ongoing Phase II study (“Carina” LYM2001) of
daratumumab in NHL. The study evaluates daratumumab monotherapy in three
different types of NHL, diffuse large B-cell lymphoma (DLBCL), follicular
lymphoma (FL) and mantle cell lymphoma (MCL). This milestone is related to
progress in the arm of the study treating patients with DLBCL.
“Daratumumab is being investigated in numerous studies for multiple myeloma,
covering all lines of therapy. We are very pleased to report progress in the
first study of daratumumab in an indication beyond multiple myeloma,” said Jan
van de Winkel, Ph.D., Chief Executive Officer of Genmab.
Daratumumab has received Orphan Drug designation from the US FDA for DLBCL, MCL
and FL.
Today’s news does not impact Genmab’s 2015 financial guidance.
About the LYM2001 study
This Phase II study (NCT02413489) is a three arm (DLBCL, FL, MCL), open-label
multicenter study which will enroll up to 210 patients with relapsed or
refractory non-Hodgkin’s lymphoma. Patients in the study will be treated with
daratumumab monotherapy. The primary endpoint of the study is overall response
rate. The safety profile of daratumumab in these diseases will also be
assessed.
About DARZALEX™ (daratumumab)
DARZALEX™ (daratumumab) injection for intravenous infusion is indicated in the
United States for the treatment of patients with multiple myeloma who have
received at least three prior lines of therapy, including a proteasome
inhibitor (PI) and an immunomodulatory agent, or who are double-refractory to a
PI and an immunomodulatory agent.1 DARZALEX is the first monoclonal antibody
(mAb) to receive U.S. Food and Drug Administration (FDA) approval to treat
multiple myeloma. For more information, visit www.DARZALEX.com.
Daratumumab is a human IgG1k monoclonal antibody (mAb) that binds with high
affinity to the CD38 molecule, which is highly expressed on the surface of
multiple myeloma cells. It is believed to induce rapid tumor cell death through
programmed cell death, or apoptosis,1,2 and multiple immune-mediated
mechanisms, including complement-dependent cytotoxicity,1,2 antibody-dependent
cellular phagocytosis3,4 and antibody-dependent cellular cytotoxicity.1,2 In
addition, daratumumab therapy results in a reduction of immune-suppressive
myeloid derived suppressor cells (MDSCs) and a subset of regulatory T cells
(Tregs) both of which express CD38. These reductions in MDSCs and Tregs were
paralleled by increases in CD4+ and CD8+ T cell numbers in both the peripheral
blood and bone marrow.1
Daratumumab is being developed by Janssen Biotech, Inc. under an exclusive
worldwide license to develop, manufacture and commercialize daratumumab from
Genmab. Five Phase III clinical studies with daratumumab in relapsed and
frontline settings are currently ongoing, and additional studies are ongoing or
planned to assess its potential in other malignant and pre-malignant diseases
on which CD38 is expressed, such as smoldering myeloma and non-Hodgkin’s
lymphoma.
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 has two approved antibodies,
Arzerra® (ofatumumab) for the treatment of certain chronic lymphocytic leukemia
indications and DARZALEX™ (daratumumab) for the treatment of heavily pretreated
or double refractory multiple myeloma. Daratumumab is in clinical development
for additional multiple myeloma indications and for non-Hodgkin’s lymphoma.
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,
and the HexaBody® platform which creates effector function enhanced antibodies.
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. For more information visit
www.genmab.com.
Contact:
Rachel Curtis Gravesen, Senior Vice President, Investor Relations &
Communications
T: +45 33 44 77 20; M: +45 25 12 62 60; E: [email protected]
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 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. Genmab does not undertake any obligation to update
or revise forward looking statements in this Company Announcement nor to
confirm such statements in relation to actual results, unless required by law.
Genmab A/S and its subsidiaries own the following trademarks: Genmab®; the
Y-shaped Genmab logo®; Genmab in combination with the Y-shaped Genmab logo™;
the DuoBody logo®; the HexaBody logo™; HuMax®; HuMax-CD20®; DuoBody®; HexaBody®
and UniBody®. Arzerra® is a trademark of Novartis AG or its affiliates.
DARZALEX™ is a trademark of Janssen Biotech, Inc.
References
1 DARZALEX Prescribing Information, November 2015.
2 De Weers et al. Daratumumab, a Novel Therapeutic Human CD38 Monoclonal
Antibody, Induces Killing of Multiple Myeloma and Other Hematological Tumors.
The Journal of Immunology. 2011; . 186, p.1840-1848.
3 Overdijk et al. Phagocytosis is a mechanism of action for daratumumab.
Available at https://ash.confex.com/ash/2012/webprogram/Paper51257.html.
Accessed September 2015.
4 Khagi and Mark. Potential role of daratumumab in the treatment of multiple
myeloma. Onco Targets Ther. 2014; 7: p. 1095–1100.
Company Announcement no. 62
CVR no. 2102 3884
Genmab A/S
Bredgade 34E
1260 Copenhagen K
Denmark