Genmab and GlaxoSmithKline Announce Positive Top-Line Results in Ofatumumab Chronic...

Genmab and GlaxoSmithKline Announce Positive Top-Line Results in Ofatumumab
Chronic Lymphocytic Leukemia Pivotal Study
Summary: Phase III Pivotal Study of Ofatumumab in Refractory CLL Meets Primary
Endpoint

COPENHAGEN, July 31 /PRNewswire-FirstCall/ -- Genmab A/S (OMX: GEN) and
GlaxoSmithKline (LSE and NYSE: GSK) announced today positive top-line results
from an interim analysis of the Phase III pivotal study evaluating ofatumumab
(HuMax-CD20(R)) to treat two groups of chronic lymphocytic leukemia (CLL)
patients with high unmet medical need. At the interim analysis, the study met
the primary endpoint in both populations and the results from the secondary
endpoints also support the primary endpoint.
The activity of ofatumumab was evaluated in 154 patients in this interim
analysis of whom 138 patients with refractory CLL were evaluable. About half
of the patients (59) in the study were refractory to both fludarabine and
alemtuzumab. The analysis also included a second group (79) who were
refractory to fludarabine and considered inappropriate candidates for
alemtuzumab due to bulky tumor in their lymph nodes. An objective response
rate of 51% (p<0.0001) consisting of 30 partial responses (PR) was achieved
in the group of patients refractory to fludarabine and alemtuzumab. In the
fludarabine refractory, alemtuzumab inappropriate patient group, an objective
response rate of 44% (p<0.0001) was achieved, including 1 complete response
(CR), and 34 PR. Achievement of the reported objective response rates are
based on evaluations by an independent committee and are subject to review
and confirmation by the regulatory authorities.
Ofatumumab was generally well tolerated by CLL patients in the study. The
most frequently reported adverse events (those that occurred at a greater
than 15% frequency) were: pyrexia, diarrhea, fatigue, cough, neutropenia,
anemia and pneumonia. There were no unexpected safety findings. None of the
14 patients tested for human anti-human antibodies (HAHA) demonstrated their
presence at 12 months.
A pre-BLA (Biologics License Application) meeting has been requested with
the FDA during which these data will be discussed with the potential of a
2008 BLA filing. There is also the potential to submit to the EU regulatory
authorities in this time frame. The full data will be submitted for
presentation to an academic meeting in due course.
"We are thrilled to report a positive outcome for the CLL patients in
this trial," said Lisa N. Drakeman, Ph.D., Chief Executive Officer of Genmab.
"This also represents a significant achievement for Genmab as we now move
toward filing of the first marketing applications for a Genmab antibody and
we look forward to working with GSK on the submissions."
"These very encouraging results suggest that ofatumumab has the potential
to provide benefits to CLL patients with very refractory disease and limited
treatment options," said Kathy Rouan, Vice President and Medicine Development
Leader at GSK. "GSK and Genmab are collaborating on a comprehensive
development program for CLL as well as non-Hodgkin's lymphoma (NHL), which we
hope will make a significant contribution to the management of these
haematologic malignancies for both patients and their physicians."
Ofatumumab is an investigational new generation fully human monoclonal
antibody that uniquely targets the small loop epitope (specific antibody
binding site) of the CD20 molecule on B cells. Ofatumumab is being developed
to treat chronic lymphocytic leukemia, follicular non-Hodgkin's lymphoma,
diffuse large B-cell lymphoma, rheumatoid arthritis and relapsing remitting
Multiple Sclerosis under a co-development and commercialization agreement
between Genmab and GlaxoSmithKline. It is not yet approved in any country.
About the trial The study includes CLL patients who are refractory to
both fludarabine and alemtuzumab and patients who are refractory to
fludarabine who are considered inappropriate candidates for alemtuzumab due
to bulky tumor in their lymph nodes. All patients in the study receive 8
weekly infusions of ofatumumab, followed by 4 monthly infusions of
ofatumumab. Patients receive 300 mg of ofatumumab at the first infusion and
2000 mg of ofatumumab at each subsequent infusion. Disease status is assessed
every 4 weeks until week 28 and then every 3 months until disease progression
or month 24. Patient recruitment is ongoing and a final analysis will be
conducted on the full study population, expected to be 100 patients in each
group.
The primary endpoint of the study is objective response over a 24 week
period from start of treatment as assessed according to the National Cancer
Institute Working Group guidelines. The secondary endpoints are duration of
response, progression free survival, time to next CLL therapy, overall
survival and adverse events.
Conference Call Genmab will hold a conference call to discuss these
results today, July 31, 2008 at:
6:00 pm CEST
5:00 pm BST
12:00 pm EDT

The conference call will be held in English.
The dial in numbers are as follows:
+1-888-740-6137 (in the US) and ask for the Genmab conference call
+1-913-312-1480 (outside the US) and ask for the Genmab conference call
To listen to a live webcast of the call please visit
http://www.genmab.com.
About Genmab A/S Genmab is a leading international biotechnology company
focused on developing fully human antibody therapeutics for unmet medical
needs. Using cutting-edge antibody technology, Genmab's world class
discovery, development and manufacturing teams have created and developed an
extensive pipeline of products for potential treatment of a variety of
diseases including cancer and autoimmune disorders. As Genmab advances
towards a commercial future, we remain committed to our primary goal of
improving the lives of patients who are in urgent need of new treatment
options. For more information on Genmab's products and technology, visit
http://www.genmab.com.
About GlaxoSmithKline One of the world's leading research-based
pharmaceutical and healthcare companies - is committed to improving the
quality of human life by enabling people to do more, feel better and live
longer.
Forward Looking Statement for Genmab: This press release 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
http://www.genmab.com. Genmab does not undertake any obligation to update or
revise forward looking statements in this press release nor to confirm such
statements in relation to actual results, unless required by law.
GlaxoSmithKline Cautionary statement regarding forward-looking statements
Under the safe harbor provisions of the U.S. Private Securities Litigation
Reform Act of 1995, GSK cautions investors that any forward-looking
statements or projections made by GSK, including those made in this
announcement, are subject to risks and uncertainties that may cause actual
results to differ materially from those projected. Factors that may affect
GSK' s operations are described under 'Risk Factors' in the 'Business Review'
in the company' s Annual Report on Form 20-F for 2007.
GlaxoSmithKline Enquiries:
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SOURCE Genmab A/S

Contact: Helle Husted, Sr. Director, Investor Relations, T: +45-33-44-77-30,
M: +45-25-27-47-13, E: hth@genmab.com