Genome Scanning to the Rescue?
This article was originally published in Start Up
Executive Summary
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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Pharmacogenomics has disappointed advocates who saw the opportunity to apply a discovery tool to the near-term goal of increasing approval chances and marketability for late-stage and marketed compounds. In return, they hoped to take a percentage of the highest-cost segment of the pharmaceutical budget. But Big Pharma is by and large not using pharmacogenomics for late-stage and marketed compounds: senior executives don't believe there's enough evidence it works and are afraid of limiting the marketability of the products by segmenting broad target populations into niches. Some also worry about uncovering potential side-effects that non-pharmacogenomic trials wouldn't reveal. Nonetheless, pharmacogenomics has made it to Big Pharma: most companies, for example, are banking samples from clinical trials to be pharmacogenomically tested retrospectively, thereby informing future trials. Not that this means the pharmacogenomics specialists will be able to sign high-value deals with the commercial side of drug companies, who believe that pharmacogenomic analysis is available from a number of sources, including internal ones, and feel they own the key assets for creating meaningful programs: compounds and patient samples. Instead, pharmacogenomics will find its place first as a discovery technology, integrated with other methods for finding, validating and prioritizing targets. That means that to succeed selling pharmacogenomics, biotechs will have to combine their pharmacogenomic assets with other discovery technologies, perhaps through mergers. An alternative: use their technologies to find drug products that they can themselves develop, perhaps later out-licensing them.
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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