BioWorld International Correspondent

PARIS - Innogenetics signed a licensing agreement with Roche Diagnostics, granting it a nonexclusive worldwide license for a genotyping test for hepatitis C.

The deal calls for Roche Diagnostics, a division of the Basel, Switzerland-based F. Hoffmann-La Roche Ltd., to make an up-front payment of €5 million to Innogenetics, of Ghent, Belgium, and to pay royalties on future sales of HCV genotyping products incorporating its intellectual property.

Innogenetics' vice president of investor relations, Jean-Christophe Donck, told BioWorld International that Roche, which is developing a comprehensive platform for the diagnosis and treatment of hepatitis C, plans to launch in the U.S. its first product incorporating Innogenetics' HCV genotyping test in the first half of 2004, but the product will be for research use only. A product for clinical applications is expected to be on the market in Europe in the second half of 2004.

Innogenetics already has licensed the technology to Bayer AG, of Leverkusen, Germany, under an agreement signed in March 2001. In that case, though, Innogenetics also manufactures the kit marketed by Bayer, which started selling it in June 2001.

Innogenetics' HCV genotyping test is based on its Line Probe Assay (LiPA) technology, a multi-parameter assay based on the reverse hybridization principle that allows the simultaneous detection of mutations and genetic variations in samples. The product is one of a range of diagnostics tests it has developed, or is developing, for HCV and other infectious diseases. They include screening, confirmation and genotyping tests (for HIV, hepatitis B and C), genetic tests (for cystic fibrosis, HLA typing) and tests for neurodegenerative diseases such as Alzheimer's.

Regarding hepatitis C in particular, Innogenetics is developing a prophylactic vaccine, which is at the preclinical stage, as well as a therapeutic vaccine that yielded encouraging results in a Phase IIa trial completed last spring. It now is being tested in a Phase IIb trial at several centers in Europe that is due for completion by the end of 2004.

Innogenetics is engaged in other diagnostics collaborations with Roche, one of which is for the development of rapid molecular microbiology tests for the identification of bacteria in hospitals. Three tests are being developed under that program, the first of which is due to be launched in the first half of 2004.

Innogenetics, which is listed on the Euronext Brussels stock exchange, raised €23 million in December through a public share offering.