Genmab — Regulatory Filings 2017

Nov 21, 2017

Company Announcement

-- Application to broaden label for daratumumab in front line multiple myeloma
submitted to EMA
-- Submission based on data from Phase III ALCYONE study
-- Genmab to receive USD 3 million in milestone payments from Janssen

Copenhagen, Denmark; November 21, 2017 – Genmab A/S (Nasdaq Copenhagen: GEN)
announced today that Janssen Pharmaceutica NV (Janssen) has submitted a Type II
variation application to the European Medicines Agency (EMA). This application
seeks to broaden the existing marketing authorization for daratumumab
(DARZALEX®) to include use in combination with bortezomib, melphalan and
prednisone, for the treatment of adult patients with newly diagnosed multiple
myeloma who are ineligible for autologous stem cell transplant (ASCT). The
submission of the application triggers milestone payments totaling USD 3
million to Genmab from Janssen. The milestone payments were included in
Genmab’s financial guidance for 2017, which was published on November 14, 2017.
In August 2012, Genmab granted Janssen an exclusive worldwide license to
develop, manufacture and commercialize daratumumab.

“We are very pleased about this submission, which marks the first application
for the use of daratumumab for patients with newly diagnosed multiple myeloma.
We look forward to working with both Janssen and the EMA so that daratumumab
can potentially become available for a broader group of multiple myeloma
patients,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

The submission is based on data from the Phase III ALCYONE study of daratumumab
in combination with bortezomib, melphalan and prednisone in front line multiple
myeloma. This data will also be used as the basis for a potential regulatory
submission to the U.S. Food and Drug Administration.

About DARZALEX® (daratumumab)
DARZALEX® (daratumumab) injection for intravenous infusion is indicated in the
United States in combination with lenalidomide and dexamethasone, or bortezomib
and dexamethasone, for the treatment of patients with multiple myeloma who have
received at least one prior therapy; in combination with pomalidomide and
dexamethasone for the treatment of patients with multiple myeloma who have
received at least two prior therapies, including lenalidomide and a proteasome
inhibitor (PI); and as a monotherapy for the treatment of patients with
multiple myeloma who have received at least three prior lines of therapy,
including a 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. DARZALEX is indicated in Europe for use in combination with
lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the
treatment of adult patients with multiple myeloma who have received at least
one prior therapy and as monotherapy for the treatment of adult patients with
relapsed and refractory multiple myeloma, whose prior therapy included a PI and
an immunomodulatory agent and who have demonstrated disease progression on the
last therapy. In Japan, DARZALEX is approved in combination with lenalidomide
and dexamethasone, or bortezomib and dexamethasone, for treatment of adults
with relapsed or refractory multiple myeloma. DARZALEX is the first human CD38
monoclonal antibody to reach the market. 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. Daratumumab triggers a person’s own immune system to
attack the cancer cells, resulting in rapid tumor cell death through multiple
immune-mediated mechanisms of action and through immunomodulatory effects, in
addition to direct tumor cell death, via apoptosis (programmed cell
death).1,2,3,4,5

Daratumumab is being developed by Janssen Biotech, Inc. under an exclusive
worldwide license to develop, manufacture and commercialize daratumumab from
Genmab. A comprehensive clinical development program, including multiple Phase
III studies, is ongoing with daratumumab in relapsed and frontline multiple
myeloma settings, 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, NKT-cell lymphoma, amyloidosis,
myelodysplastic syndromes and solid tumors. Daratumumab has received two
Breakthrough Therapy Designations from the U.S. FDA, for multiple myeloma, as
both a monotherapy and in combination with other therapies.

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,
DARZALEX® (daratumumab) for the treatment of certain multiple myeloma
indications, and Arzerra® (ofatumumab) for the treatment of certain chronic
lymphocytic leukemia indications. Daratumumab is in clinical development for
additional multiple myeloma indications, other blood cancers, and solid tumors.
A subcutaneous formulation of ofatumumab is in development for relapsing
multiple sclerosis. 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: rcg@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 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.

1 DARZALEX Prescribing information, June 2017. Available at:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/761036s004lbl.pdf
Last accessed June 2017
2 De Weers, M 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: 1840-1848.
3 Overdijk, MB, et al. Antibody-mediated phagocytosis contributes to the
anti-tumor activity of the therapeutic antibody daratumumab in lymphoma and
multiple myeloma. MAbs. 2015; 7: 311-21.
4 Krejcik, MD et al. Daratumumab Depletes CD38+ Immune-regulatory Cells,
Promotes T-cell Expansion, and Skews T-cell Repertoire in Multiple Myeloma.
Blood. 2016; 128: 384-94.
5 Jansen, JH et al. Daratumumab, a human CD38 antibody induces apoptosis of
myeloma tumor cells via Fc receptor-mediated crosslinking. Blood. 2012;
120(21): abstract 2974.

Company Announcement no. 42
CVR no. 2102 3884
LEI Code 529900MTJPDPE4MHJ122

Genmab A/S
Kalvebod Brygge 43
1560 Copenhagen V
Denmark