Genmab — Regulatory Filings 2012

Dec 9, 2012

News Details

Ad-hoc | 9 December 2012 18:01

New Preliminary Efficacy Data for Daratumumab Presented at ASH

Genmab A/S

09.12.2012 18:01

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Company Announcement

-- Preliminary safety and efficacy data from final patients in part 1 of study
continue to be encouraging
-- Data presented in oral presentation today at the ASH Annual Meeting
-- Part 2 of study, evaluating 24 month daratumumab dosing initiated

Copenhagen, Denmark; December 9, 2012 - Genmab A/S (OMX: GEN) announced today
new preliminary safety and efficacy data from the Phase I/II clinical study of
daratumumab (HuMax(r)-CD38) in multiple myeloma. Of the three patients treated
at the highest (and final) dose level in the study (24 mg/kg of daratumumab),
two achieved a partial response (PR) and one achieved a minimal response (MR).
Altogether, 8 of 12 patients in the study who received daratumumab at a dose
level of 4 mg/kg or higher achieved at least a MR.

The data presented today at the American Society of Hematology (ASH) annual
meeting was from 32 patients who received daratumumab in doses up to 24 mg/kg.
The data continued to show no major safety issues with daratumumab. The most
relevant drug related adverse events were brief, low-grade infusion related
reactions and a temporary drop in the level of NK cells.

Part 2 of the study in which patients will receive multiple 8 mg/kg doses of
daratumumab for 24 months or until disease progression has been initiated.

'Data from this ongoing study of daratumumab in heavily pretreated multiple
myeloma patients continues to be very encouraging and we are excited that the
second part of the study where we will collect data on extended dosing of
daratumumab has begun,' said Jan van de Winkel, Ph.D., Chief Executive Officer
of Genmab.

Prof. Torben Plesner, Vejle Hospital, Denmark, will present the slides from
today's oral presentation as part of Genmab's Post ASH Seminar, which will be
webcast on December 17 at www.genmab.com.

About the study
This ongoing Phase I/II dose escalation study will include a maximum of 108
patients with multiple myeloma that is relapsed or refractory to at least two
different prior treatments. The primary objective of the study is to establish
the safety profile of daratumumab and secondary objectives are to establish
maximum tolerated dose and efficacy. An independent data monitoring committee
evaluates the safety data for each cohort before dose-escalation.

About daratumumab
Daratumumab is a human CD38 monoclonal antibody with broad-spectrum killing
activity. Daratumumab is in clinical development for multiple myeloma (MM).
Daratumumab targets the CD38 molecule which is highly expressed on the surface
of multiple myeloma cells. Daratumumab could also have potential in other
cancers on which CD38 is expressed, including diffuse large B-cell lymphoma,
chronic lymphocytic leukemia, acute lymphoblastic leukemia, plasma cell
leukemia, acute myeloid leukemia, follicular lymphoma and mantle cell lymphoma.
In August 2012, Genmab granted Janssen Biotech, Inc. an exclusive worldwide
license to develop and commercialize daratumumab.

About Genmab A/S
Genmab is a publicly traded, international biotechnology company specializing
in the creation and development of differentiated human antibody therapeutics
for the treatment of cancer. Founded in 1999, the company's first marketed
antibody, ofatumumab (Arzerra(r)), was approved to treat chronic lymphocytic
leukemia in patients who are refractory to fludarabine and alemtuzumab after
less than eight years in development. Genmab's validated and next generation
antibody technologies are expected to provide a steady stream of future product
candidates. Partnering of 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(r); the Y-shaped Genmab logo(r); HuMax(r); HuMax-CD20(r); DuoBody(r) and UniBody(r)
are all trademarks of Genmab A/S. Arzerra(r) is a trademark of GlaxoSmithKline.

Company Announcement no. 36
CVR no. 2102 3884

Genmab A/S
Bredgade 34E
1260 Copenhagen K
Denmark

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Language: English
Company: Genmab A/S

          Denmark

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ISIN: DK0010272202
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