NEW YORK, Jan. 18-Third Wave Technologies is developing a pharmacogenomic test for a chemotherapy drug in collaboration with major Japanese drug manufacturer Daiichi Pure Chemical Co., the company said on Friday.
The test, developed with Third Wave's SNP-based analysis techniques, will measure patient predisposition to side effects from Irinotecan, a cancer therapeutic manufactured by Daiichi.
Clinical trials for the new diagnostic will begin in Japan next quarter, and Third Wave hopes to have the product on the market in early 2003, said company CEO and chairman Lance Fors. According to Fors, the product may be the first pharmacogenomic test for adverse drug reactions to reach the market.
Researchers at Daiichi and at Nagoya University will run clinical studies in Japan to validate the clinical relevance of SNPs in the UGT 1A1 gene that may be associated with Irinotecan side effects.
Ultimately, Third Wave and Daiichi will develop a diagnostic product to be marketed in tandem with Irinotecan. That drug was recently approved to treat colon and rectal cancer in the United States and reached $425 million in sales in this country in 2000, according to the company.
However, the chemotherapy drug can cause serious diarrhea in approximately one of four patients. This test will be designed to predict which patients will be likely to develop this adverse reaction, and which are likely to do well with the treatment.
Daiichi will market the test in Japan, but Pharmacia controls the marketing rights to Irinotecan the United States. Fors said that Third Wave would retain the rights to the diagnostic outside Japan, but had not yet struck any additional marketing agreements.
"This is part of the larger strategy for us to focus on both efficacy and adverse events for existing and new drugs," said Fors. "Of all the polymorphisms in the scientific literature related to drug metabolism enzymes, we've been able to end-license 75 percent of them. Our long-term strategy is to enable and bring solutions to personalized medicine. We'll be doing a lot of these studies with pharma, managed care, and with different academic institutions to develop profiles around certain drugs."
Fors did not say what the test would cost, but that its price would be consistent with "outcome benefit," namely, preventing the expensive hospitalizations that Irinotecan-related diarrhea can cause.
Third Wave is a publicly owned company headquartered in Madison, Wisc.
Daiichi Pure Chemicals develops and markets diagnostic products in Japan and internationally, and plans to develop a line of pharmacogenomic diagnostics.