Genaissance patent for novel methods to correlate genetics with drug safety and efficacy

Genaissance Pharmaceuticals received a Notice of Allowance from the United States Patent and Trademark Office for a patent claiming methods for identifying correlations between the safety and efficacy of drugs and patients' unique genetic signatures.

Genaissance developed this technology, the DecoGen(R) Informatics System, with the goal of reducing adverse events and increasing positive outcomes of broadly used medicines through more informed prescribing decisions. The allowed patent claims specifically cover novel haplotype correlation methods for identifying drug safety and efficacy markers as well as disease susceptibility markers.

The DecoGen(R) Informatics System combines a comprehensive database of genetic variation information with a set of computer applications for storing and analyzing genetic variation, especially in the context of pharmacogenetic clinical trials. The Company expects that the patent, titled "Methods for Obtaining and Using Haplotype Data," will issue in the first half of 2005.

The DecoGen(R) system is a key component in Genaissance's Phase II pharmacogenetic development plans for vilazodone, an antidepressant drug candidate recently licensed from Merck KGaA, and also in the fulfillment of obligations in support of clinical trials with its pharmaceutical and biopharmaceutical partners.

"DecoGen(R)'s throughput and accuracy have established it as an important technology for discovering genetic variables that are likely to interfere with a drug's intended features," notes Kevin Rakin, President and Chief Executive Officer of Genaissance. "This knowledge can be of immense value to physicians in their current prescribing patterns and may also help in the reformulation of drugs to avoid adverse events."

"Our unique informatics-intensive approach of utilizing haplotype-based association methods has increased our ability to identify genetic markers of clinical significance. Recently published results from STRENGTH and data from CARING have identified haplotype markers of drug response (both efficacy and safety) that are of greater specificity and sensitivity than have previously been discovered using standard pharmacogenetic association methods," stated Richard Judson, Ph.D., Chief Scientific Officer of Genaissance.

Genaissance has patent applications pending that cover other methods within the DecoGen(R) Informatics System, including Genaissance's HAP(TM) Builder software, which builds haplotypes with high accuracy from genotypes for multiple single nucleotide polymorphisms (SNPs) in a gene.