Genmab — Regulatory Filings 2017

Apr 28, 2017

Company Announcement

-- DARZALEX approved in Europe in combination with lenalidomide and
dexamethasone, or bortezomib and dexamethasone in patients who have
received at least one prior therapy
-- Genmab to receive milestone payments totaling USD 48 million from Janssen
upon the first sale of DARZALEX in the newly approved indications

Copenhagen, Denmark; April 28, 2017 – Genmab A/S (Nasdaq Copenhagen: GEN)
announced today that the European Commission (EC) has granted a marketing
authorization for DARZALEX® (daratumumab) 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.
The EC approval follows a positive opinion issued for DARZALEX by the Committee
for Medicinal Products for Human Use (CHMP) of the European Medicines Agency
(EMA) in February 2017. This approval also converts the previous conditional
marketing authorization for DARZALEX to a full approval. DARZALEX is being
developed under an August 2012 agreement in which Genmab granted Janssen an
exclusive worldwide license to develop, manufacture and commercialize the
product.

Genmab will receive milestone payments totaling USD 48 million from Janssen
Biotech, Inc. in connection with the first commercial sales of DARZALEX under
the expanded label. The sales are expected to occur quickly after the approval.
These milestone payments were included in the financial guidance issued by
Genmab on February 22, 2017 and therefore there is no change to the company’s
financial guidance following this approval.

“We are very pleased that DARZALEX is now approved in Europe in combination
with other standard multiple myeloma therapies and that a far greater number of
patients suffering from this incurable disease will now have access to this
first-in-class immunotherapy,” said Jan van de Winkel, Ph.D., Chief Executive
Officer of Genmab.

The positive opinion of the CHMP was based on data from two Phase III studies:
the CASTOR study of daratumumab in combination with bortezomib and
dexamethasone versus bortezomib and dexamethasone alone in patients with
relapsed or refractory multiple myeloma (published in The New England Journal
of Medicine in August 2016), and the POLLUX study of daratumumab in combination
with lenalidomide and dexamethasone versus lenalidomide and dexamethasone alone
in patients with relapsed or refractory multiple myeloma (published in the New
England Journal of Medicine in October 2016). Data from two early stage
studies also supported the approval: the Phase I MMY1001 study (daratumumab in
combination with pomalidomide and dexamethasone) and the Phase I/II GEN503
study (daratumumab in combination with lenalidomide and dexamethasone).

About the CASTOR study
The Phase III CASTOR study included 498 patients who had relapsed or refractory
multiple myeloma. Patients were randomized to receive either daratumumab
combined with subcutaneous bortezomib (a type of chemotherapy, called a
proteasome inhibitor) and dexamethasone (a corticosteroid), or bortezomib and
dexamethasone alone. The study met the primary endpoint of improving
progression free survival (PFS); Hazard Ratio (HR) = 0.39, 95% CI 0.28-0.53,
p<0.0001. Patients who received treatment with daratumumab in combination with
bortezomib and dexamethasone had a 61% reduction in risk of their disease
progressing, compared to those who did not receive daratumumab. The median PFS
for patients treated with daratumumab has not been reached, compared to median
PFS of 7.2 months for patients who did not receive daratumumab. Daratumumab
also significantly increased the overall response rate (ORR) (83% vs. 63%,
p<0.0001), including doubling rates of complete response (CR) or better (19%
vs. 9%) and rates of very good partial response (VGPR) or better (59% vs. 29%).
The proportion of patients that achieved minimal residual disease (MRD)
negative status at the 10-4 threshold (one tumor cell in 10,000 white cells)
was 13.5% vs 2.8%, p<0.000006 for patients treated with daratumumab versus
patients who did not receive daratumumab. The most common grade 3 or 4 adverse
events in patients treated with daratumumab in combination with bortezomib and
dexamethasone compared to those who only received bortezomib and dexamethasone
were thrombocytopenia (45% vs 33%), anemia (14% vs 16%) and neutropenia (13% vs
4%). Daratumumab-associated infusion-related reactions were reported in 45% of
patients, were mostly grade 1/2, and occurred predominantly during the first
infusion. This is consistent with the reported safety profile of daratumumab
monotherapy and combination therapy of bortezomib and dexamethasone.

About the POLLUX study
The Phase III POLLUX study enrolled 569 patients who had relapsed or refractory
multiple myeloma. Patients were randomized to receive either daratumumab
combined with lenalidomide (an immunomodulatory drug) and dexamethasone, or
lenalidomide and dexamethasone alone. The study met the primary endpoint of
improving progression-free survival (PFS) (Hazard Ratio (HR) = 0.37; 95% CI
0.27-0.52; p<0.0001) for patients treated with daratumumab versus patients who
did not receive daratumumab. Patients who received treatment with daratumumab
in combination with lenalidomide and dexamethasone had a 63% reduction in risk
of their disease progressing, compared to those who did not receive
daratumumab. The median PFS for patients treated with daratumumab in
combination with lenalidomide and dexamethasone has not been reached, compared
to an estimated median PFS of 18.4 months for patients who received
lenalidomide and dexamethasone alone. Additionally, daratumumab significantly
increased ORR (93% vs. 76%, p<0.0001), including doubling rates of CR or better
(43% vs. 19%), as well as rates of VGPR or better (76% vs. 44%). The proportion
of patients that achieved minimal residual disease (MRD) negative status at the
10-4 threshold was 29% vs 7.8%, p<0.000001 for patients treated with
daratumumab versus patients who did not receive daratumumab. The most common
grade 3 or 4 adverse events in patients treated with daratumumab in combination
with lenalidomide and dexamethasone versus those who received only lenalidomide
and dexamethasone were neutropenia (52% vs 37%), thrombocytopenia (13% vs 14%),
and anemia (12% vs 20%). Daratumumab-associated infusion-related reactions
occurred in 48% of patients, were mostly grade 1/2, and occurred predominantly
during the first infusion. Overall, the reported safety profile was consistent
with known toxicities of daratumumab monotherapy and combination therapy of
lenalidomide and dexamethasone.

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 were expected to be diagnosed with
multiple myeloma and approximately 12,650 people were 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 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 and as a monotherapy 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.6 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. DARZALEX is the first
human CD38 monoclonal antibody approved in Europe. 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).6,7,8,9,10

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 multiple myeloma 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,
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: 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 FDA 2015. Daratumumab Prescribing information. Available at:
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/761036Orig1s000lbledt.p
df.
Last accessed December 2016.

7 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.

8 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.

9 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.

10 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. 16
CVR no. 2102 3884
LEI Code 529900MTJPDPE4MHJ122

Genmab A/S
Bredgade 34E
1260 Copenhagen K
Denmark