HAMBURG, Germany - Epidauros Biotechnologie AG, a German pharmacogenomic start-up, has entered an exclusive collaboration with Parexel International Corp., of Boston, the world's third-largest contract research and medical marketing services organization.

Under the terms of the deal, Parexel will make an equity investment in Epidauros, of Bernried, Germany. Epidauros was founded in 1998 as the first German pharmacogenomics company. G|nther Heinrich, its founder, experienced the urgent need for pharmacogenomic knowledge during his career in the research departments of the pharmaceutical giants CIBA and Sandoz.

"When I was developing two antibodies to control the rejection of organ transplants, they showed excellent results in animal studies and early-stage clinical trials," he said. "However, as a result of Phase III trials, one of the antibodies had to be withdrawn because it failed in some of the patients."

Only 20 percent of all drugs developed in the labs of the pharmaceutical industry achieve admission. All others fail during clinical trials, because in some participants they lead to severe side effects or show no effects at all. Therefore, the number of trials and patients involved has more than doubled during the last 20 years - one of the main reasons for the growing development costs of new drugs.

"Usually, the reason for failure in clinical trials is simple," Heinrich said. "Every patient is different. Slight variations in the genetic makeup lead to different metabolic activities, and these in turn influence the individual's reaction to a certain drug."

Epidauros will aid companies developing new drugs with insights into these differences, Heinrich said. Parexel, a company with 15 years of experience in drug development services, clinical trials management and regulatory consulting, will address the legal, ethical and logistical problems of recruiting patients and collecting blood samples.

Currently, Epidauros is setting up automatic sequencers, and it will soon have the capacity to sequence 2 million base pairs a day. The sequencing lab is headed by Hans-Peter Klenk, who participated in the sequencing of three of the first 10 bacterial genomes.

"If polymorphisms have been identified, we'll have to establish a correlation between genotypes and enzymes involved in the metabolism of the drug in question," Heinrich said.

As soon as pharmacologically important polymorphisms are identified, Epidauros will develop diagnostic kits for the rapid and easy identification of these phenotypes. "In the future, we will have drugs that are prescribed only after a test has been performed which will predict the response of the patient," Heinrich added. "This will lead to cheaper and safer drugs, and the number of drugs entering the market will surely rise."

Werner Herrmann, CEO of Parexel in Germany and chief scientific officer for the company in Boston, told BioWorld International: "Today, there is much hope that one can indeed individualize drug prescriptions. However, no one knows exactly how long it will take and how much effort will be necessary. So, Parexel was looking for ways to make pharmacogenomics economically feasible, and the situation in Germany is very favorable, as we get excellent funding there."

Under the terms of the cooperation, Parexel has acquired an interest in Epidauros and will be paid for the rendering of services. Both companies are part of a research consortium that was founded to develop methods for routine genotyping of polymorphisms of enzymes involved in drug metabolism. The group comprises several university research departments and OPAL Jena, of Jena, Germany, a company that focuses on the development of instrumentation for biotechnology applications.

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