Genmab — Regulatory Filings 2011

Aug 5, 2011

News Details

Ad-hoc | 5 August 2011 18:15

Genmab Announces Top-Line Phase II Results for Ofatumumab Combined with Chemotherapy in Second Line Aggressive Lymphoma

Genmab A/S

05.08.2011 18:15

Dissemination of a Adhoc News, transmitted by DGAP - a company of
EquityStory AG.
The issuer is solely responsible for the content of this announcement.

---

• Overall response rate of 61% in patients with relapsed/refractory aggressive
  lymphoma
• No unexpected safety findings
• Data to be submitted for presentation at ASH

Copenhagen, Denmark; August 5, 2011 - Genmab A/S (OMX: GEN) announced today
top-line results from a Phase II study of ofatumumab in combination with
salvage chemotherapy to treat relapsed or refractory aggressive lymphoma,
including Diffuse Large B-Cell Lymphoma (DLBCL).

A total of 61 patients with aggressive lymphoma, who had persistent or
progressive disease after first-line treatment with rituximab combined with
chemotherapy, were treated in the study. The overall response rate (ORR) was
61%. There were no unexpected safety findings. The most common grade 3 or
higher adverse events were thrombocytopenia (59% of pts), anemia (36%),
neutropenia (26%), lymphopenia (23%), leukopenia (18%), febrile neutropenia
(13%) and hypokalemia (13%).

These data will be submitted for presentation at the 2011 Annual Meeting of the
American Society of Hematology (ASH) in San Diego, US this December.

About the study
Patients in the study had previously received first line treatment with
rituximab combined with standard chemotherapy. Patients received three cycles
of ofatumumab in combination with ICE or DHAP salvage chemotherapy, which is
used when cancer recurs or does not respond to first line treatment. The
primary objective of the study was to evaluate the overall response rate of
patients to ofatumumab in combination with ICE or DHAP chemotherapy according
to criteria recognized by regulatory authorities known as the Revised Response
Criteria for Malignant Lymphoma.

About Diffuse Large B-Cell Lymphoma
Diffuse Large B-Cell Lymphoma is a cancer of B-lymphocytes. DLBCL represents
30% of non-Hodgkin's lymphomas in adults and is the most common lymphoid
malignancy in the western world. Relapsed DLBCL occurs when the cancer returns
after a period of improvement. Refractory DLBCL occurs when the cancer is
resistant to or does not respond to initial treatment.

About ofatumumab
Ofatumumab is a human monoclonal antibody which targets an epitope in the CD20
molecule encompassing parts of the small and large extracellular loops (Teeling
et al 2006). Ofatumumab is not approved in any country for treatment of
relapsed or refractory DLBCL. Ofatumumab is being developed under a
co-development and commercialization agreement between Genmab and
GlaxoSmithKline.

In the United States, ofatumumab is indicated for the treatment of patients
with chronic lymphocytic leukemia (CLL) refractory to fludarabine and
alemtuzumab. The effectiveness of ofatumumab is based on the demonstration of
durable objective responses. No data demonstrate an improvement in
disease-related symptoms or increased survival.

Ofatumumab can cause serious infusion reactions, prolonged and severe
cytopenias, Progressive Multifocal Leukoencephalopathy (PML), including fatal
PML, and Hepatitis B infection and reactivation.

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, Arzerra(r) (ofatumumab), was approved to treat chronic lymphocytic
leukemia that is 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 &
Communication
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
product discovery and development, 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
section 'Risk Management' in Genmab's Annual Report, which is 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); HuMax-EGFr(tm);
HuMax-IL8(tm); HuMax-TAC(tm); HuMax-CD38(tm); HuMax-TF(tm); HuMax-Her2(tm); HuMax-cMet(tm),
HuMax-CD74(tm), DuoBody(tm) and UniBody(r) are all trademarks of Genmab A/S. Arzerra(r)
is a trademark of GlaxoSmithKline.

Company Announcement no. 26
CVR no. 2102 3884

Genmab A/S
Bredgade 34
1260 Copenhagen K
Denmark

Click on, or paste the following link into your web browser, to view the associated documents

https://newsclient.omxgroup.com/cds/DisclosureAttachmentServlet?messageAttachmentId=357899

News Source: NASDAQ OMX

05.08.2011 DGAP's Distribution Services include Regulatory Announcements,
Financial/Corporate News and Press Releases.
Media archive at www.dgap-medientreff.de and www.dgap.de

---

Language: English
Company: Genmab A/S

          Dänemark

Phone:
Fax:
E-mail:
Internet:
ISIN: DK0010272202
WKN:

End of Announcement DGAP News-Service

---