London, UK & Philadelphia, USA and Copenhagen, Denmark;
December 19, 2006 - GlaxoSmithKline (GSK) and Genmab A/S (CSE:GEN)
today announced a worldwide agreement to co-develop and commercialize
HuMax-CD20™ (ofatumumab), a fully human monoclonal antibody in late stage
development for CD20 positive B-cell chronic lymphocytic leukemia (B-CLL)
and follicular non-Hodgkin's lymphoma (NHL) and in Phase II for
rheumatoid arthritis (RA).
Under the terms of the agreement, Genmab will receive a license fee of DKK
582 million (approximately £ 52 million and approximately $102 million*),
and GSK will invest DKK 2,033 million (approximately £ 183 million and
approximately $357 million) to purchase, 4,471,202 ordinary shares of
Genmab. The total potential value of this agreement, in the event of full
commercial success, in cancer and various autoimmune and inflammatory
diseases, could exceed DKK 12.0 billion (approximately £ 1.1 billion and
approximately $2.1 billion), including the initial license fee and equity
purchase, milestone payments, totaling DKK 9.0 billion (approximately £ 0.8
billion and approximately $ 1.6 billion) and expected development,
commercial manufacturing and commercialization costs.
In addition, Genmab will be entitled to receive tiered double digit
royalties on global sales of HuMax-CD20.
GSK will receive an exclusive worldwide license to HuMax-CD20 as well as
any other antibodies with affinity for the CD20 antigen which Genmab may
develop. GSK will also have an exclusive option to a CD20 UniBody™ to be
developed in collaboration with Genmab. GSK and Genmab will co-develop
HuMax-CD20. Genmab will be responsible for development costs until 2008,
including costs of the two ongoing late stage oncology studies after which
development costs will be shared equally between GSK and Genmab. GSK will
be solely responsible for the manufacturing and commercialization of
HuMax-CD20.
Genmab will have an option to co-promote HuMax-CD20 in a targeted oncology
setting in the US and in the Nordic region. Should this be undertaken,
Genmab will also have the option co-promote Bexxar™ and Arranon™ in the US
and Atriance™ in the relevant countries of the Nordic region.
The agreement is subject to review by the US Government under the
Hart-Scott-Rodino Act and will become effective after clearing review.
Dr. Moncef Slaoui, Chairman of Research and Development, GSK, commented,
"We believe that this alliance is a significant step for GSK and
Genmab. By combining the skills and knowledge of Genmab in developing fully
human antibodies, such as HuMax-CD20, and the substantial experience of GSK
in clinical and commercial development, we hope to be able to bring this
innovative and potentially valuable medicine to patients as soon as
possible."
"This alliance puts the tremendous strength of GSK's development,
sales and marketing expertise behind HuMax-CD20," said Lisa N.
Drakeman, Ph.D., Chief Executive Officer of Genmab. "We are looking
forward to our collaboration and working together to maximize the value of
this product that has the potential to benefit so many patients with
different diseases."
Conference Call
Genmab will hold a conference call about the news today, December 19th at
3:30 PM CET
2:30 PM GMT
9:30 AM EST
The dial in numbers are as follows:
+1 800 475 3716 (in the US)
+1 719 457 2728 (outside the US)
The conference call will be held in English.
To listen to a live webcast of the call please visit:
https://cis.premconf.com/sc/scw.dll/usr?cid=vlllrcrwwszvmlnx
Simultaneously with this release, Genmab will publish a separate stock
exchange release containing more information regarding the placement of
Genmab shares to GSK which is made in direct connection with the global
development and commercialization agreement regarding HuMax-CD20.
About HuMax-CD20 (ofatumumab)
HuMax-CD20 is a fully human antibody which binds to the CD20 antigen on the
surface of B-cells, white blood cells that normally play a positive role in
the immune system. Since certain lymphomas and leukemias arise from the
same sources as white blood cells, these cancers frequently have CD20 on
the surface. When HuMax-CD20 binds to CD20 the antibody recruits the
body's natural defenses to attack and kill these selected cells, which
can be implicated in various forms of cancer, autoimmune and inflammatory
diseases. Stem cells (B-cell progenitors) in bone marrow lack the CD20
antigen, allowing healthy B-cells to regenerate after treatment and return
to normal levels within several months. Mature B-cells, known as plasma
cells, which produce antibodies that support immunity do not carry the CD20
marker and are thus also spared to continue their vital role.
About CLL, NHL and RA
CLL is the most common leukemia in adults in the US and most of Western
Europe. The incidence is 8,100 to 12,500 new cases in the US per year and
85-95% of the cases are of B-cell origin. CLL is a subgroup of
non-Hodgkin's lymphoma (NHL) and together with small lymphocytic
lymphoma (SLL) corresponds to around 20% of all NHL cases.
The incidence of NHL in the US is approximately 54,000 new cases per year,
accounting for approximately 5% of all US cancer deaths. Follicular
lymphoma (FL) is a subgroup of NHL. FL is the second most common lymphoma
in the US and Europe, accounting for 11 to 35% of all NHL.
RA is a systemic inflammatory disease which affects 0.8-1% of all
populations, approximately 2 million people in the US alone. B-cells are
crucial pathogenic elements in the induction and development of RA. As
B-cells are involved in various cellular interactions with immune cells,
B-cell depletion after HuMax-CD20 treatment may diminish RA disease
activity.
The Global Co-Development and Commercialization Agreement regarding
HuMax-CD20 including the Private Placement to GlaxoSmithKline will not
affect the Company's financial guidance for 2006. The impact on 2007
will be included in the Company's financial guidance for 2007.
* Figures based on an exchange rate of 11.0992 from Danish kroner to
Pounds sterling and an exchange rate of 5.6920 from Danish kroner to US
dollars as of December 18th 2006.
About GlaxoSmithKline
GlaxoSmithKline is one of the world's leading research-based
pharmaceutical and healthcare companies and is committed to improving the
quality of human life by enabling people to do more, feel better and live
longer. For more information, visit GlaxoSmithKline on the World Wide Web
at www.gsk.com
About Genmab A/S
Genmab A/S is a biotechnology company that creates and develops human
antibodies for the treatment of life-threatening and debilitating diseases.
Genmab has numerous products in development to treat cancer, infectious
disease, rheumatoid arthritis and other inflammatory conditions, and
intends to continue assembling a broad portfolio of new therapeutic
products. At present, Genmab has multiple partnerships to gain access to
disease targets and develop novel human antibodies including agreements
with Roche and Amgen. A broad alliance provides Genmab with access to
Medarex, Inc.'s array of proprietary technologies, including the
UltiMAb® platform for the rapid creation and development of human
antibodies to virtually any disease target. In addition, Genmab has
developed UniBody™, a new proprietary technology that creates a stable,
smaller antibody format. Genmab has operations in Europe and the US. For
more information about Genmab, visit www.genmab.com.
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. Genmab is not under an
obligation to up-date statements regarding the future following the
publication of this release; nor to confirm such statements in relation to
actual results, unless this is required by law.
GlaxoSmithKline Forward-Looking Statements
Under the safe harbor provisions of the US Private Securities
Litigation Reform Act of 1995, the company cautions investors that any
forward-looking statements or projections made by the company, 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 the Group's operations are described under
'Risk Factors' in the Operating and Financial Review and Prospects
in the company's Annual Report on Form 20-F for 2005.