Genmab — Regulatory Filings 2016

Apr 1, 2016

Company Announcement

-- CHMP issued positive opinion for DARZALEX for relapsed and refractory
multiple myeloma
-- Final decision from European Commission expected in the coming months

Copenhagen, Denmark; April 1, 2016 – Genmab A/S (Nasdaq Copenhagen: GEN)
announced today that the Committee for Medicinal Products for Human Use (CHMP)
of the European Medicines Agency (EMA) has issued a positive opinion
recommending the grant of a conditional marketing authorization for DARZALEX®
(daratumumab) in the European Union. The recommendation is for the use of
DARZALEX as monotherapy for the treatment of adult patients with relapsed and
refractory multiple myeloma, whose prior therapy included a proteasome
inhibitor (PI) and an immunomodulatory agent and who have demonstrated disease
progression on the last therapy.

The positive opinion of the CHMP was predominantly based on data from the Phase
II study (SIRIUS MMY2002, published in The Lancet in January 2016) of
daratumumab in multiple myeloma patients who have received at least three prior
lines of therapy including both a PI and an immunomodulatory agent, or who are
double refractory to a PI and an immunomodulatory agent. Additional data from
four other studies, including the Phase I/II GEN501 monotherapy study
(published in The New England Journal of Medicine in August 2015) support the
opinion. In August 2012, Genmab granted Janssen Biotech, Inc. an exclusive
worldwide license to develop, manufacture and commercialize daratumumab.

“We are very pleased to receive the positive opinion from the CHMP for the use
of DARZALEX as monotherapy in patients with relapsed and refractory multiple
myeloma. The CHMP opinion brings Genmab and its partner Janssen one step
closer towards offering a fundamentally new treatment option to patients with
multiple myeloma in Europe, and we look forward to the decision of the European
Commission,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

A CHMP opinion is one of the final steps in the regulatory process of the
European Medicines Agency. The CHMP reviewed DARZALEX under the EMA’s
accelerated assessment program. A final decision by the European Commission is
anticipated in 60 – 90 days.

In November 2015, DARZALEX was approved by the U.S. FDA under a Breakthrough
Therapy Designation and Priority Review 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.

Safety and Efficacy Data from the Phase II MMY2002 (SIRIUS) Study
Results from the pivotal Phase II SIRIUS study showed that treatment with
single-agent DARZALEX resulted in an overall response rate (ORR) of 29.2% in
patients who had received a median of five prior lines of therapy, including a
PI and an immunomodulatory agent. Stringent complete response (sCR) was
reported in 2.8% of patients, very good partial response (VGPR) was reported in
9.4% of patients, and partial response (PR) was reported in 17% of patients.1

For responders, the median duration of response was 7.4 months. At baseline,
97% of patients were refractory to their last line of therapy, 95% were
refractory to both a PI and an immunomodulatory agent, and 77% were refractory
to alkylating agents.1

The warnings and precautions for DARZALEX include infusion-related reactions
(IRRs) and interference with serological testing.1 The most commonly occurring
adverse reactions (in 20 percent or more of patients in three pooled clinical
studies) were IRRs, fatigue, nausea, back pain, anemia, neutropenia (abnormally
low levels of neutrophils, a type of white blood cell) and thrombocytopenia
(abnormally low levels of platelets in the blood).1

In data from three pooled clinical studies including a total of 156 patients,
four percent of patients discontinued treatment due to adverse reactions, none
of which were considered drug-related. IRRs were reported in approximately half
of all patients treated with DARZALEX, the majority of which (91 percent)
occurred during the first infusion. Seven percent of patients had an IRR at
more than one infusion. Common (?5 percent) symptoms of IRRs included nasal
congestion, chills, cough, allergic rhinitis, throat irritation, dyspnea, and
nausea, and these were mild to moderate in severity.1 Severe IRRs (4 percent),
including bronchospasm (1.3 percent), hypertension (1.3 percent), and hypoxia,
or decreased oxygen supply to the tissues (0.6 percent), were also reported.1

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.2 Multiple
myeloma is the third most common blood cancer in the U.S., after leukemia and
lymphoma.3 Approximately 26,850 new patients were estimated to be diagnosed
with multiple myeloma and approximately 11,240 people would die from the
disease in the U.S. in 2015.4 Globally, it was estimated that 124,225 people
would be diagnosed and 87,084 would die from the disease in 2015.5 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.6 Patients who relapse after
treatment with standard therapies, including proteasome inhibitors or
immunomodulatory agents, have poor prognoses and few treatment options.7

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,1,8 and multiple immune-mediated
mechanisms, including complement-dependent cytotoxicity,1,8 antibody-dependent
cellular phagocytosis9,10 and antibody-dependent cellular cytotoxicity.1,8 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 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: 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 DARZALEX Prescribing Information, November 2015.

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

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

4 American Cancer Society. "What are the key statistics about multiple
myeloma?"
http://www.cancer.org/cancer/multiplemyeloma/detailedguide/multiple-myeloma-key-
statistics.
Accessed September 2015.

5 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 September 2015.

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

7 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.

8 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: 1840-1848.

9 Overjijk 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 and Mark. Potential role of daratumumab in the treatment of multiple
myeloma. Onco Targets Ther. 2014; 7: 1095–1100.

Company Announcement no. 17
CVR no. 2102 3884

Genmab A/S
Bredgade 34E
1260 Copenhagen K
Denmark