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GeneProt, Duke University and Novartis Collaborate for Industrial-Scale Proteomic Study of Coronary Heart Disease.

GENEVA -- GeneProt Inc. today announced that during the second half of 2001 more than 12 liters of plasma was collected by investigators at Duke University Medical Center, Durham, NC, for plasma proteomic analysis by GeneProt for a study sponsored by Novartis Pharma AG of Basel, Switzerland. This study is the first of its kind in heart disease and is expected to reveal novel factors involved in the number one killer in the Western world, coronary heart disease.

Subjects were enrolled through the Duke Databank for Cardiovascular Disease, the worlds largest and longest running cardiac catheterization-based database. From the tens of thousands of patients in the database, 241 carefully selected patients consisting of a population with coronary artery disease and a control population with no disease were sampled. After matching of gender, age, and ethnicity, and excluding patients with obvious plasma protein abnormalities, 6 liters of pooled plasma from a set of 53 patients and from a set of 53 control subjects were established.

"It is absolutely necessary to use large volumes in order to have sufficient quantities of those proteins present at very low concentration; this involves pooling, which also serves to dilute normal differences which occur between individuals unrelated to the disease process," explained Keith Rose, GeneProt's CSO.

GeneProt began in Q1 2002 comparing the total protein profile (the proteome) found in the two plasma pools at its industrial-scale proteomics facility in Geneva, Switzerland. Proteins that are present in one sample but not the other, or are present in widely differing amounts, are likely to be associated with the disease process and are therefore promising candidates for further investigation to better understand what causes the disease and to guide development of new biomarkers and therapeutics. Using two-and-a-half liters of each of the diseased and control pools, GeneProt has completed the analysis of the polypeptides and smaller proteins using its MicroProt(TM) process. It expects to finish analysis of the larger proteins using its MacroProt(TM) process in Q4 2002. This is the first time that in-depth proteomic analysis has been tackled on the scale of many liters of plasma, which is over one thousand times more than is usually used. This allows identification of proteins in low concentration that may be novel important factors in causing and treating disease. One of the world's most powerful computers will be used to analyze the complex information coming from this study. Interesting and differentially expressed proteins are being synthesized for further study and the unpooled individual portions of plasma are available for follow-up studies. Patent applications are being filed on the proteins of interest.

"We analyzed more than 25,000 fractions in our analysis of the small proteins and have delivered to Novartis a protein database; some interesting new proteins have already been synthesized, which validates our vision of an industrial-scale proteomics approach," said Keith Rose, GeneProt's CSO.

"Proteomics is a key to future pharmaceutical development. We look forward to continued collaboration with Duke and Novartis to leverage our combined expertise in the effort to accelerate the pace of pharmaceutical innovation," said Bertrand Damour, GeneProt's CFO and Co-Chair.

"The quality of the samples analysed by GeneProt in the frame of our collaboration to uncover all significant plasma proteins related to Coronary Artery Disease was a key element to our future success. To the best of my knowledge and thanks to the Duke clinicians, it is the first time that this amount of plasma sample with such a quality was collected. It will allow us to capitalize on this unique comparison of the plasma proteome, the gene expression profile of blood cells and the DNA of strictly phenotyped CAD patients vs. normal subjects," said Jacky Vonderscher global head of "Integrative Compound & Product Profiling" at Novartis Pharma and sponsor of the study.

"This study is a completely new approach to unraveling the mysteries of the world's number one health problem," says Christopher Granger, the main investigator at the Duke Clinical Research Institute. "Although the sequencing of the human genome was heralded as one of science's greatest accomplishments, studies such as this one are essential to bridge from the code of life in the genome to the specific factors that are actually causing disease that may be detected in the human blood in the form of the proteome."

About GeneProt(TM) -- GeneProt, Inc. is an industrial-scale proteomics company focused on separating, identifying, characterizing, selecting and, when appropriate, synthesizing certain human proteins on behalf of life sciences companies and for its own account for use in the discovery and development of new therapeutic proteins, protein drug targets and protein biomarkers. GeneProt has brought together and integrated international teams of leading experts in proteomics and bioinformatics with the vision, insight and ability to speed the development and enhance the quality of tomorrow's human therapies. GeneProt's partners include leading pharmaceutical and technology companies and academic and scientific institutions such as Novartis, Hewlett Packard, Bruker Daltonics, Waters Corporation, Lion bioscience and the Swiss Institute of Bioinformatics. The company will pursue additional partnerships with organizations that can derive value from or bring value to GeneProt's unique offerings in proteomics discovery and production. For more information, please visit http://www.geneprot.com/.

About Duke -- Duke University Medical Center, consistently ranks as one of the best in the country. The hospital, which is licensed for 1,019 beds, is the site of cutting edge patient care based on the latest findings from the laboratories of Duke scientists. It is also the training ground for the health care leaders of tomorrow through Duke's renowned schools of medicine and nursing, as well as through its advanced residency and fellowship programs. Duke Medical Center researchers receive more than $200 million annually in funding from the National Institutes of Health. The Duke Clinical Research Institute is an international leader in the design and coordination of large international multi-center clinical trials as well as the analysis of the data collected. For more than 30 years, the DCRI has been a leader in the development and testing of the latest medications for heart and other diseases.

About Novartis -- Novartis AG is a world leader in healthcare with core businesses in pharmaceuticals, consumer health, generics, eye-care, and animal health. In 2001, the Group's businesses achieved sales of CHF 32.0 billion (USD 19.1 billion) and a net income of CHF 7.0 billion (USD 4.2 billion). The Group invested approximately CHF 4.2 billion (USD 2.5 billion) in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ about 74 000 people and operate in over 140 countries around the world. For further information please consult http://www.novartis.com

CONTACT: Bertrand Damour of GeneProt, +41-22-719-88-75; Bertrand.Damour@Geneprot.com

Web site: http://www.geneprot.com/ http://www.novartis.com/
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Date:Sep 9, 2002
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