Genmab — Regulatory Filings 2016

Aug 23, 2016

Company Announcement

-- Application to broaden label for daratumumab for relapsed multiple myeloma
submitted to EMA by Janssen
-- Submission based on data from two Phase III studies, CASTOR and POLLUX
-- Genmab to receive USD 10 million in milestone payments from Janssen

Copenhagen, Denmark; August 23, 2016 – Genmab A/S (Nasdaq Copenhagen: GEN)
announced today that Janssen Pharmaceutica NV (Janssen) has submitted a
variation to the Marketing Authorization to the European Medicines Agency (EMA)
seeking to broaden the existing marketing authorization for daratumumab
(DARZALEX®) to include treatment of adult patients with multiple myeloma who
have received at least one prior therapy. The submission of the application
triggers milestone payments totaling USD 10 million to Genmab from Janssen. The
milestone payments were included in Genmab’s financial guidance for 2016 that
was published on August 9, 2016. In August 2012, Genmab granted Janssen
Biotech, Inc. an exclusive worldwide license to develop, manufacture and
commercialize daratumumab.

“Daratumumab represents a new hope for people suffering from multiple myeloma,
a disease which is presently incurable. We look forward to working together
with Janssen and the EMA to making daratumumab available to a far wider group
of patients,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

The submission includes data from two Phase III studies: the CASTOR study of
daratumumab in combination with bortezomib and dexamethasone versus bortezomib
and dexamethasone in patients with relapsed or refractory multiple myeloma, and
the POLLUX study of daratumumab in combination with lenalidomide and
dexamethasone versus lenalidomide and dexamethasone in patients with relapsed
or refractory multiple myeloma. The submission also included data from the
Phase I study of daratumumab in combination with pomalidomide and dexamethasone
in relapsed or refractory multiple myeloma.

Janssen submitted a supplemental Biologics License Application for daratumumab
in combination with lenalidomide and dexamethasone, or bortezomib and
dexamethasone, for treatment of patients with multiple myeloma who received at
least one prior therapy to the U.S. Food and Drug Administration in August
2016.

About multiple myeloma
Multiple myeloma is an incurable blood cancer that starts in the bone marrow
and is characterized by an excess proliferation of plasma cells.1 Multiple
myeloma is the third most common blood cancer in the U.S., after leukemia and
lymphoma.2 Approximately 30,330 new patients are expected to be diagnosed with
multiple myeloma and approximately 12,650 people are expected to die from the
disease in the U.S. in 2016.3 Globally, it was estimated that 124,225 people
would be diagnosed and 87,084 would die from the disease in 2015.4 While some
patients with multiple myeloma have no symptoms at all, most patients are
diagnosed due to symptoms which can include bone problems, low blood counts,
calcium elevation, kidney problems or infections.5 Patients who relapse after
treatment with standard therapies, including proteasome inhibitors or
immunomodulatory agents, have poor prognoses and few treatment options.6

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.7 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 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. 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,7,8 and multiple immune-mediated
mechanisms, including complement-dependent cytotoxicity,7,8 antibody-dependent
cellular phagocytosis9,10 and antibody-dependent cellular cytotoxicity.7,8 In
addition, daratumumab therapy results in a reduction of immune-suppressive
myeloid derived suppressor cells (MDSCs) and subsets of regulatory T cells
(Tregs) and B cells (Bregs), all of which express CD38. These reductions in
MDSCs, Tregs and Bregs were accompanied by increases in CD4+ and CD8+ T cell
numbers in both the peripheral blood and bone marrow.7,11

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, non-Hodgkin’s lymphoma
and a solid tumor.

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: r.gravesen@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 American Cancer Society. "Multiple Myeloma Overview." Available at
http://www.cancer.org/cancer/multiplemyeloma/detailedguide/multiple-myeloma-what
-is-multiple-myeloma.
Accessed June 2016.

2 National Cancer Institute. "A Snapshot of Myeloma." Available at
www.cancer.gov/research/progress/snapshots/myeloma. Accessed June 2016.

3 American Cancer Society. "What are the key statistics about multiple
myeloma?"
http://www.cancer.org/cancer/multiplemyeloma/detailedguide/multiple-myeloma-key-
statistics.
Accessed June 2016.

4 GLOBOCAN 2012: Estimated Cancer Incidence, Mortality and Prevalence
Worldwide: Number of New Cancers in 2015. Available at:
http://globocan.iarc.fr/old/burden.asp?selection_pop=224900&Text-p=World&selecti
on_cancer=17270&Text-c=Multiple+myeloma&pYear=3&type=0&window=1&submit=%C2%A0Exe
cute.
Accessed June 2016.

5 American Cancer Society. "How is Multiple Myeloma Diagnosed?"
http://www.cancer.org/cancer/multiplemyeloma/detailedguide/multiple-myeloma-diag
nosis.
Accessed June 2016.

6 Kumar, SK et al. Risk of progression and survival in multiple myeloma
relapsing after last therapy with IMiDs and bortezomib: a multicenter
international myeloma working group study. Leukemia. 2012; 26:149-57.

7 DARZALEX US Prescribing Information, November 2015.

8 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.

9 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.

10 Khagi, Y and Mark, TM. Potential role of daratumumab in the treatment of
multiple myeloma. Onco Targets Ther. 2014; 7: 1095–1100.

11 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.

Company Announcement no. 38
CVR no. 2102 3884

Genmab A/S
Bredgade 34E
1260 Copenhagen K
Denmark