Genmab — Regulatory Filings 2015

Nov 23, 2015

Company Announcement

-- Phase III study of ofatumumab in follicular lymphoma will be stopped early
-- Planned interim analysis by an Independent Data Monitoring Committee showed
that the study was unlikely to show superiority of ofatumumab if completed
-- No new safety signals for ofatumumab were identified

Copenhagen, Denmark; November 23, 2015 – Genmab A/S (OMX: GEN) announced today
that the Phase III study of single agent ofatumumab compared to single agent
rituximab in patients with follicular non-Hodgkin’s lymphoma (NHL) that has
relapsed at least 6 months after completion of treatment with a
rituximab-containing regimen will be stopped early. The decision to stop the
study was made after a planned interim analysis performed by an Independent
Data Monitoring Committee (IDMC) showed that it was unlikely that ofatumumab
would show superiority if the trial was to be completed as planned.

“The outcome of the interim analysis in this study is disappointing as we had
hoped to see superiority of ofatumumab. The data from the study will now be
prepared so that it can be presented at a future scientific conference,” said
Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

Today’s news does not impact any other ongoing studies with ofatumumab.

About the study
This Phase III study aimed to randomize up to 516 patients to receive
ofatumumab (1000 mg) or rituximab (375 mg/m2) by intravenous infusion for four
weekly doses. Patients who had stable or responsive disease then received
single infusions of ofatumumab or rituximab every two months for four
additional doses for a total of eight doses over nine months. The primary
endpoint of the study was progression free survival.

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. 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 as treatment for relapsed
follicular NHL.

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

Arzerra is marketed under a collaboration agreement between Genmab and Novartis.

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.

Company Announcement no. 60
CVR no. 2102 3884

Genmab A/S
Bredgade 34E
1260 Copenhagen K
Denmark