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Genaissance Throws Hat into Drug-Market Ring; FDA to Review First Candidate in 05

SAN FRANCISCO, Jan. 24 - Genaissance Pharmaceuticals is taking its pharmacogenomics research to a new level as it unveiled plans to  begin developing novel forms of the schizophrenia drug clozapine and a statin. The company, which said it plans to produce these personalized drugs by combining them with targeted genetic markers, intends to submit its first candidate for US Food and Drug Administration approval in 2005.


"We are beginning our own HAP drug pipeline," Genaissance Chief Technology Officer Gerald Vovis told attendees at the 4th annual Personalized Medicine conference here. "We are evolving into a pharmaceutical company."


The company's HAP technology uses algorithms to sift through SNPs in order to uncover disease markers. Genaissance has a cache of almost 100,000 haplotypes from more than 5,400 genes, it said.


The company is taking this step "because we've demonstrated our HAP technology and it's time to work on drugs to maximize the return to our investors," said Vovis, who compared the company's evolution to Human Genome Sciences' and Millennium Pharmaceuticals'. "We've developed pharmacogenomics technology, [we have] all the elements needed for the drug development process."


Genaissance will focus on developing drugs already off-patent or with significant side-effect related safety issues.


"We're trying to take the lowest possible risk, to take compounds which already have clinical results," Vovis said. "Either drugs coming off patent or stalled someplace in a clinical trial because there are issues. We're looking to develop best-in-class drugs."


In addition to offering a marker with the drug, the company may also alter the compound to offer improved efficacy for a specific patient population, said Vovis. A compound alteration may allow the company to file for a patent, he said.


Clozapine, while said to be an effective treatment for many patients, in some cases causes dangerous white blood cell depletion, according the company. Genaissance hopes its technology will lead to a marker to better target a patient population that will not experience that side effect.


The company is currently conducting a study of statin drugs to link genetic differences with varying patient responses to the medication.