Glaxo Puts SNPs to Work
Glaxo Wellcome was naturally disappointed that it had to withdraw troglitazone (Romozin), a new treatment for Type II diabetes, from the UK market in December 1997, just four months after launch. The problems with troglitazone only really started showing up once the drug came to market, and started being used in patient populations far larger than those assembled for clinical trials. "If we could've identified people who would have adverse events, then we would've had a market for that drug," asserts Alan Roses, MD, a clinical neurologist who became Glaxo's VP and worldwide director, genetics, in June 1997. In fact.Glaxo could have predicted the complications with troglitazone by examining patients' genetic profiles, Roses asserts.
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The FDA is now sorting through public comments on draft guidance the agency issued recently, to encourage drug developers to voluntarily share pharmacogenomic data with it. Companies have some serious concerns that the agency means to address by the summer with the issuance of formal guidelines and the launching of a public forum for discussion about pharmacogenomics.
As yet, pharmacogenomics has failed to set the world on fire--either as a basic drug-discovery method, or as a way of helping drug candidates win regulatory approval. Perlegen Sciences Inc., a spin-off of Affymetrix, thinks its technology can deliver on the promise. The start-up has used high-density chips to sequence the genomes of 25 people, and from that work assembled a definitive catalog of 1.5 million SNPs or single nucleotide polymorphisms. The company claims its techology is 225 times less expensive than anything anyone else has, and therefore makes whole-genome scanning possible. Perlegen recently announced it would work on behalf of GlaxoSmithKline PLC, seeking genetic markers of disease, and the firm expects to sign more deals soon. To protect itself against getting stuck as a service company, Perlegen is beginning to deploy its technology on its own behalf, hunting genes for major diseases. The firm expects to gain bargaining power as it accumulates proof of its capabilities. The prospect of commoditization is not as threatening as it was when financing markets were good--given the funding slow-down, new technologies that might have competed will not be hurrying along as fast.
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