Diagnostics as Venture Investments
This article was originally published in Start Up
Will the emergence of new biological targets as a result of genomics and proteomics change venture investors' prejudice against diagnostics? No--or at least not until patented biomarkers can be tied more closely to the cause of the disease and to a therapeutic that treats it.
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Tessera Diagnostics, founded in December 2000, is focusing on developing a group of protein markers for early detection of cancer. It's first indication is prostate cancer, and it has in-licensed a group of 14 markers from a family of proteins called NMPs for early detection of the disease. It believes some of these markers are specific and highly sensitive to the disease, and as a group they will provide better information than any test currently available.
Corixa's recent deal with Ortho-Clinical Diagnostics brings Ortho exclusive worldwide diagnostics rights to Corixa's breast cancer genes and antigens and helps Ortho gain a foothold in the emerging area of molecular testing. It also illustrates how biotech companies caught up in long-term programs for therapeutics can capture some near-term value. While Corixa's lead drug is delayed at the FDA, the deal gives the company a source of revenues that may be small but is at least real.
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.