Genmab — Regulatory Filings 2016

Mar 10, 2016

Company Announcement

-- sBLA submitted to US FDA for ofatumumab in combination with fludarabine and
cyclophosphamide in relapsed CLL by Novartis
-- Submission based on data from the Phase III COMPLEMENT 2 study

Copenhagen, Denmark; March 10, 2016 – Genmab A/S (Nasdaq Copenhagen: GEN)
announced today that a supplemental Biologics License Application (sBLA) has
been submitted to the U.S. Food and Drug Administration (FDA) for the use of
ofatumumab (Arzerra®) in combination with fludarabine and cyclophosphamide
(FC) for the treatment of patients with relapsed chronic lymphocytic leukemia
(CLL). The application was submitted by Novartis under the ofatumumab
collaboration between Novartis and Genmab.

The application is based on results from a Phase III study, COMPLEMENT 2 which
evaluated ofatumumab in combination with FC versus FC alone in patients with
relapsed CLL. Top-line results from this trial were reported in April 2015.
The study met the primary endpoint with a median progression free survival in
patients receiving ofatumumab in combination with FC of 28.9 months, compared
to 18.8 months in patients receiving FC alone (HR =0.67, p=0.0032).

“The data from the COMPLEMENT 2 study demonstrated the potential of ofatumumab
in combination with FC to help patients with relapsed CLL. We are pleased that
Novartis has moved forward with a regulatory application for ofatumumab in this
indication in the U.S.,” said Jan van de Winkel, Ph.D., Chief Executive Officer
of Genmab.

About CLL
CLL is the most common form of leukemia in the western world, accounting for
30% of adult leukemias.1 Most CLL patients experience disease progression
despite initial response to therapy and may require additional treatment.2

About COMPLEMENT 2
COMPLEMENT 2 (NCT00824265) is an open-label, two-arm, randomized, Phase III
study, which included 365 patients in 18 countries with relapsed CLL. Patients
in the study were randomized 1:1 to treatment with up to six cycles of
ofatumumab in combination with fludarabine and cyclophosphamide or up to six
cycles with fludarabine and cyclophosphamide alone.

The primary endpoint of the study was PFS, which was assessed by an Independent
Review Committee (IRC) according to the International Workshop for Chronic
Lymphocytic Leukaemia (iwCLL) updated 2008 National Cancer Institute-sponsored
Working Group (NCIWG) guidelines.3 Secondary endpoints included overall
response rate, overall survival, patient reported outcomes, time to response,
duration of response, time to progression, time to next therapy, safety
assessments and quality of life.

About Ofatumumab (Arzerra®)
Ofatumumab is a human monoclonal antibody that is designed to target the CD20
molecule found on the surface of chronic lymphocytic leukemia (CLL) cells and
normal B lymphocytes.

In the United States, Arzerra is approved for use in combination with
chlorambucil for the treatment of previously untreated patients with CLL for
whom fludarabine-based therapy is considered inappropriate. Arzerra is also
approved as extended treatment of patients who are in complete or partial
response after at least two lines of therapy for recurrent or progressive CLL
in the U.S. In the European Union, Arzerra is approved for use in combination
with chlorambucil or bendamustine for the treatment of patients with CLL who
have not received prior therapy and who are not eligible for fludarabine-based
therapy. In more than 50 countries worldwide, Arzerra is also indicated as
monotherapy for the treatment of patients with CLL who are refractory after
prior treatment with fludarabine and alemtuzumab.

Arzerra is not approved anywhere in the world in combination with fludarabine
and cyclophosphamide as treatment for relapsed CLL.

Please see full Prescribing Information, including Boxed WARNING for Arzerra
(ofatumumab).

Arzerra is marketed under a collaboration agreement between Genmab and
Novartis. Novartis has rights to develop ofatumumab in autoimmune indications,
including multiple sclerosis.

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.

References
1 GlobalData. EpiCast Report: Chronic Lymphocytic Leukemia Epidemiology
Forecast to 2023. Published May 2014.

2 Veliz M, Pinilla-Ibarz J. Treatment of relapsed or refractory chronic
lymphocytic leukemia. Cancer Control. 2012; 1:37-53.

3 Hallek M, Cheson BD, Catovsky D, et al. Guidelines for the diagnosis and
treatment of chronic lymphocytic leukemia: a report from the International
Workshop on Chronic Lymphocytic Leukemia updating the National Cancer
Institute-Working Group 1996 guidelines. Blood 2008; 111: 5446-56.

Company Announcement no. 12
CVR no. 2102 3884

Genmab A/S
Bredgade 34E
1260 Copenhagen K
Denmark