Genmab — Regulatory Filings 2016

Jul 26, 2016

Company Announcement

-- Daratumumab receives Breakthrough Therapy Designation in combination with
standard of care regimens for multiple myeloma patients who have received
at least one prior line of therapy
-- Potential for accelerated review
-- Marks second Breakthrough Therapy Designation for daratumumab

Copenhagen, Denmark; July 26, 2016 – Genmab A/S (Nasdaq Copenhagen: GEN)
announced today that the U.S. Food and Drug Administration (FDA) has granted
Breakthrough Therapy Designation for DARZALEX® (daratumumab) injection 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. Breakthrough Therapy Designation is a
program intended to expedite the development and review of drugs to treat
serious or life-threatening diseases in cases where preliminary clinical
evidence shows that the drug may provide substantial improvements over
available therapy. In August 2012, Genmab granted Janssen Biotech, Inc. an
exclusive worldwide license to develop and commercialize daratumumab.

“This is the second time daratumumab has earned the distinction of a
Breakthrough Therapy Designation. We are pleased that the FDA continues to
recognize the potential of daratumumab to help patients with multiple myeloma.
We continue to work with our strategic partner Janssen and the regulatory
authorities to advance daratumumab to bring this treatment to more patients
suffering from multiple myeloma as quickly as possible,” said Jan van de
Winkel, Ph.D., Chief Executive Officer of Genmab.

The Breakthrough Therapy Designation for daratumumab was granted on the basis
of data from two Phase III studies: CASTOR (MMY3004; NCT02136134) evaluating
daratumumab in combination with bortezomib and dexamethasone versus bortezomib
and dexamethasone alone in patients with relapsed or refractory multiple
myeloma, and POLLUX (MMY3003; NCT02076009) evaluating daratumumab in
combination with lenalidomide and dexamethasone versus lenalidomide and
dexamethasone in patients with relapsed or refractory multiple myeloma.

About Breakthrough Therapy Designation
The Breakthrough Therapy Designation was enacted as part of the 2012 FDA Safety
and Innovation Act (FDASIA) and is intended to expedite development of drugs to
treat serious and life-threatening medical conditions when preliminary clinical
evidence demonstrates that the drug may have substantial improvement on at
least one clinically significant endpoint over available therapies.
Breakthrough Therapy Designation includes all the features of the Fast Track
Designation, as well as more intensive guidance from the FDA on a drug’s
clinical development program.

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. 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,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 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.1,5

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 indication.

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 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: 311-321.

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

5Krejcik, MD et al. Daratumumab Depletes CD38+ Immune-regulatory Cells,
Promotes T-cell Expansion, and Skews T-cell Repertoire in Multiple Myeloma.
Blood. 2016; pii: blood-2015-12-687749. [Epub ahead of print].

Company Announcement no. 31
CVR no. 2102 3884

Genmab A/S
Bredgade 34E
1260 Copenhagen K
Denmark