Genmab — Regulatory Filings 2015

Sep 4, 2015

Company Announcement

-- U.S. FDA grants Priority Review to daratumumab
-- PDUFA target date has been set to March 9, 2016

Copenhagen, Denmark; September 4, 2015 – Genmab A/S (OMX: GEN) announced today
that the U.S. Food and Drug Administration (FDA) has granted Priority Review to
the Biologics License Application (BLA) for daratumumab. The BLA is for
daratumumab as a treatment for patients with multiple myeloma who have received
at least three different lines of therapy including both a proteasome inhibitor
and an immunomodulatory agent (IMiD) or who are double refractory to a
proteasome inhibitor and an IMiD. A rolling BLA submission was started by
Genmab’s licensing partner, Janssen Biotech, Inc. in June and was completed on
July 9, 2015. In August 2012, Genmab granted Janssen an exclusive worldwide
license to develop, manufacture and commercialize daratumumab.

Priority Review is an FDA designation for drugs that treat a serious condition
and may provide a significant improvement in safety or efficacy. The FDA aims
to complete its review of the daratumumab BLA within six months and has
assigned a Prescription Drug User Fee Act (PDUFA) target date of March 9, 2016.

“We are pleased that the FDA has granted Priority Review for daratumumab in
double refractory multiple myeloma. If approved, daratumumab has the potential
to make a real difference in the lives of people who have run out of other
treatment options for multiple myeloma,” said Jan van de Winkel, Ph.D., Chief
Executive Officer of Genmab.

The BLA submission includes data from the Phase II study (Sirius MMY2002) of
daratumumab in multiple myeloma patients who have received at least three prior
lines of therapy including both a PI and an IMiD, or who are double refractory
to a PI and an IMiD. However, safety and efficacy data from the Phase I/II
study (GEN501) and safety data from three other studies, have also been
included in the BLA submission. Daratumumab received a Breakthrough Therapy
Designation for this indication from the FDA in May 2013.

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 26,850 new patients will be diagnosed with multiple
myeloma and approximately 11,240 people will die from the disease in the U.S.
in 2015.3 Globally, it is estimated that 124,225 people will be diagnosed and
87,084 will 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 PIs or IMiDs, have poor prognoses and few treatment
options.6

About daratumumab
Daratumumab is an investigational 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 induces rapid tumor cell death through
multiple immune-mediated mechanisms7, including complement-dependent
cytotoxicity7, antibody-dependent cellular phagocytosis8 and antibody-dependent
cellular cytotoxicity7, as well as via induction of apoptosis9. Five Phase III
clinical studies with daratumumab in relapsed and frontline settings are
currently ongoing. 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 lymphoma. Daratumumab
has been granted Breakthrough Therapy Designation from the US FDA.

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 currently has one marketed
antibody, Arzerra® (ofatumumab) for the treatment of certain chronic
lymphocytic leukemia indications and daratumumab in clinical development for
multiple myeloma and non-Hodgkin’s lymphoma, in addition to other clinical
programs, and an innovative pre-clinical 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.
Genmab's deep antibody expertise is expected to provide a stream of future
product candidates. Partnering of selected innovative product candidates and
technologies is a key focus of Genmab’s strategy and the company 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 Pharma AG.

References
1 American Cancer Society. "Multiple Myeloma Overview." Available at
http://www.cancer.org/cancer/multiplemyeloma/detailedguide/multiple-myeloma-what
-is-multiple-myeloma.
Accessed August 2015.

2 National Cancer Institute. "A Snapshot of Myeloma." Available at
www.cancer.gov/research/progress/snapshots/myeloma. Accessed August 2015.

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

4 GLOBOCAN 2012: Estimated Cancer Incidence, Mortality and Prevalence
Worldwide. 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 August 2015.

5 American Cancer Society. "How is Multiple Myeloma Diagnosed?"
http://www.cancer.org/cancer/multiplemyeloma/detailedguide/multiple-myeloma-diag
nosis.
Accessed August 2015.

6 Kumar, SK et al. Leukemia. 2012 Jan;26(1):149-57.

7 Michael 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. February 1, 2011vol. 186 no. 3
1840-1848.

8 Yulian Khagi and Tomer M Mark. Potential role of daratumumab in the treatment
of multiple myeloma. Onco Targets Ther. 2014; 7: 1095–1100.

9 Jing Yang and Qing Yi. Therapeutic monoclonal antibodies for multiple
myeloma: an update and future perspectives. Am J Blood Res. 2011; 1(1): 22–33.

Company Announcement no. 41
CVR no. 2102 3884

Genmab A/S
Bredgade 34E
1260 Copenhagen K
Denmark