The Development of DNA-Based Tests for Drug Response Will Help to
Deliver to Each Individual Patient the Safest and Most Effective Treatment
Regimes
Copenhagen, DENMARK and Reykjavik, ICELAND, June 12, 2001 -
Genmab A/S (CSE:GEN and Neuer Markt:GE9) and deCODE genetics (Nasdaq/Nasdaq
Europe:DCGN) today announced the signing of an agreement to develop a
DNA-based test to predict individual clinical response to Genmab’s antibody
treatment for rheumatoid arthritis (RA). Such tests promise to become a
standard means of delivering more personalized therapeutic regimes, helping
to ensure that each individual patient is prescribed the medicines that will
give them the best results as early as possible. Exclusive of potential sales
royalties, Genmab will provide deCODE with a significant package of committed
research funding and potential milestone payments for a successfully marketed
product.
Under the terms of the agreement, deCODE and its pharmacogenomics and
clinical trials subsidiary Encode will conduct studies using Icelandic
patients and patients from broader populations aimed at identifying key
genetic factors that can accurately predict clinical response to treatments
for moderate to severe RA. These studies will identify genetic factors
predictive of responsiveness to HuMax-CD4, a fully human monoclonal antibody
developed by Genmab and now in Phase II clinical trials for use in treating
the disease. With the results of this research, deCODE will develop an RNA-
or DNA-based test that can be employed by doctors to determine the best
treatment regimes for individual RA patients. deCODE and Genmab will also
analyze the findings from their pharmacogenomics research to identify
promising targets for the development of additional monoclonal antibody
therapeutics. deCODE is already working with Roche to identify genes linked
to RA for the purpose of developing novel small molecule treatments.
Since becoming a wholly-owned deCODE subsidiary in November 2000, Encode has
enrolled large numbers of patients for clinical trials being conducted in
Iceland and in Europe for companies such as Merck, Novartis, AstraZeneca,
Schering-Plough and Biogen.
“We think that genomics based diagnostic tests will help patients receive the
product most likely to benefit them. As not all products work for all
patients, this should result in the best and most cost effective treatment
for patients, and will minimize the risk of side effects from ineffective
drugs,” said Lisa N. Drakeman, Ph.D., Chief Executive Officer of Genmab. “We
hope to develop a diagnostic test to identify patients most likely to respond
to our antibody and thus position HuMax-CD4 to reach the appropriate patients
as early in their course of treatment as possible.”
“This collaboration is a very exciting validation of the power of our
approach to the study of drug response,” said Kari Stefansson, CEO of deCODE.
“I believe very firmly that RNA- and DNA-based diagnostics such as those we
will be creating with Genmab will be at the heart of next generation medicine
in RA and other diseases, making sure that the right drugs get to the right
patients without a process of trial and error. Fully human monoclonal
antibodies also offer great promise for the development of more effective
treatments, and Genmab is a clear leader in this field.”
RA is a common, chronic, debilitating disease of the joints that affects 2.5
million people in the United States alone. Hu-Max-CD4 is a biologic product
designed to interrupt the inflammation and deterioration of joint mobility
and function that characterizes RA. Biologics are the first family of drugs
shown to be effective in slowing the progression of the disease, making
pharmacogenomic tests like those deCODE and Genmab will be developing a
crucial element in future treatment regimes. Employed together, these tests
and new drugs like Hu-Max-CD4 offer the possibility of giving patients safe,
personally tailored therapeutics that can be of real benefit even to those
with only mild symptoms of the disease.
deCODE and Encode analyze drug response as a phenotype with strong genetic
components. This is the same approach deCODE has used to identify key genes
involving common diseases, and it enables the company to combine powerful
genetic linkage analysis - utilizing its genealogical database covering the
entire Icelandic population - with more traditional gene expression and
candidate gene research. By combining these methodologies, deCODE has already
developed a highly predictive genetic test for responsiveness to steroid
treatments among asthma patients and expects to be able to develop the RA
products in less than two years. deCODE and Genmab will also analyze the
findings from their pharmacogenomics research to identify promising targets
for the development of additional monoclonal antibody therapeutics. deCODE is
already working with Roche to identify genes linked to RA for the purpose of
developing novel small molecule treatments.