GlaxoSmithKline and Genmab Announce Amendment to Ofatumumab Agreement
02 July 2010 - 2:30AM
Summary: GSK and Genmab announce an amendment to the ofatumumab
co-development and commercialization agreement.
GlaxoSmithKline (GSK) and Genmab A/S (Copenhagen:GEN) announced
today an amendment to the ofatumumab co-development and
commercialization agreement. Under the terms of the amendment, GSK
will take responsibility for developing ofatumumab in autoimmune
indications whilst continuing to jointly develop ofatumumab with
Genmab in oncology indications.
Genmab will receive an up front payment of GBP 90 million (DKK
815 million) from GSK. Genmab's future funding commitment for the
development of ofatumumab in oncology indications will be capped at
a total of GBP 145 million (DKK 1,314 million), including a yearly
spending cap of GBP 17 million (DKK 154 million) for each of the
next six years starting with 2010. Future milestones due to Genmab
under the oncology development program will be reduced by 50%.
There will be no change in royalty tiers to Genmab in the oncology
program.
GSK is currently planning a number of Phase II clinical studies
to take ofatumumab forward in autoimmune indications. "Autoimmune
diseases represent an area of high unmet medical need. GSK's
growing biopharmaceutical capabilities coupled with our deep
therapy area expertise will greatly facilitate the development of
ofatumumab in these indications," said Ian Tomlinson, Senior Vice
President, Biopharmaceutical R&D, GSK. GSK will be solely
responsible for funding the development in these indications. As a
result, Genmab will forego development milestones for autoimmune
indications and the first two sales milestones while retaining a
double digit royalty on sales.
"The amendment to the ofatumumab agreement clearly highlights
Genmab and GSK's commitment to further develop this important
product," said Prof. Jan G.J. van de Winkel, Ph.D., Chief Executive
Officer of Genmab. "We have a really excellent partner in GSK.
Their flexibility has allowed us to not only ensure that we extract
the best possible value from ofatumumab, but also strengthen the
financial security of Genmab."
The amendment to the ofatumumab agreement is expected to have a
material impact on Genmab's 2010 financial guidance which will be
updated with the company's second quarter report on August 17,
2010.
The financial terms of the amendment to the ofatumumab
co-development and commercialization agreement are denominated in
British Pounds (GBP). Solely for the convenience of the reader,
this press release contains a conversion of such GBP amounts into
Danish Kroner (DKK) using the Danish Central Bank closing rate on
July 1, 2010 which was GBP 1.00 = DKK 9.0600.
Genmab will hold a conference call to discuss today's news on
July 2 at:
10:00 AM CEST 9:00 AM BST 4:00 AM EDT
The conference call will be held in English.
The dial in numbers are as follows:
+1 866 966 9439 (in the US) and provide conference ID no.
85618918 + 44 1452 555 566 (outside the US) and provide conference
ID no. 85618918
A live webcast of the call and relevant slides will be available
at www.genmab.com. The webcast will also be archived on Genmab's
website.
About GlaxoSmithKline
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. For company information, visit
GlaxoSmithKline at http://www.gsk.com.
About Genmab A/S
Genmab is a leading international biotechnology company focused
on developing fully human antibody therapeutics for the potential
treatment of cancer. Genmab's world class discovery and development
teams are using cutting-edge technology to create and develop
products to address unmet medical needs. Our primary goal is to
improve the lives of patients who are in urgent need of new
treatment options. For more information on Genmab's products and
technology, visit www.genmab.com.
This Stock Exchange 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 www.genmab.com. Genmab does not undertake any
obligation to update or revise forward looking statements in this
Stock Exchange Release 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-HepC(TM);
HuMax-CD38(TM); HuMax-CD32b(TM); HuMax-TF(TM); HuMax-Her2(TM);
HuMax-VEGF(TM); HuMax-Wnt; HuMax-cMet(TM) and UniBody(R) are all
trademarks of Genmab A/S. Arzerra(R) is a trademark of
GlaxoSmithKline.
Stock Exchange Release no. 24/2010
CONTACT: Genmab A/S
Helle Husted, Vice President, Investor Relations
+45 33 44 77 30,
Mobile: +45 25 27 47 13
h.husted@genmab.com