To: nigel bates who wrote (23 ) 6/12/2001 1:55:05 AM From: nigel bates Respond to of 313 The Development of DNA-based Tests for Drug Response Will Help to Deliver to Each Individual Patient the Safest And Most Effective Treatment Regimes REYKJAVIK, Iceland and COPENHAGEN, Denmark, June 12 /PRNewswire/ -- deCODE genetics Inc. (Nasdaq: DCGN; Nasdaq Europe) and Genmab A/S (CSE: GEN; Neuer Markt: GE9) 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. ``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.'' ``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.'' 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 diseease. 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....