Press Releases
GlaxoSmithKline and Genmab Announce Amendment to Ofatumumab Agreement
London and Denmark
Jul 1, 2010
GlaxoSmithKline (NYSE and LSE: GSK) and Genmab
A/S (OMX: GEN) announced today an amendment to the ofatumumab
co-development and commercialisation 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 upfront 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 programme will be reduced by 50%. There will be
no change in royalty tiers to Genmab in the oncology programme.
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 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 17 August 2010.
The financial terms of the amendment to the ofatumumab co-development
and commercialisation 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 1 July 2010 which was GBP 1.00 =
DKK 9.0600.
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.
Genmab A/S - 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.
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 2009.
Genmab Forward Looking Statement
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 website. 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.
Source: GlaxoSmithKline plc