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"Our opportunity is to educate clinicians, and we've already begun that process," says Stylli. "But the most potent form of education is going to be the clinical validation studies that we're embarking on." The company plans to initiate a 10,000-patient trial for the T21 Down's syndrome test.

The industry may view these sorts of tests as outside the pharma realm, but it fits the bill for companies searching for adjacent markets and a broader arena to play in. Sequenom also acts as a CRO for genetic research, which can help create a more exacting R&D. "It can make R&D a little bit less like dart-throwing," says Miller Tabak's Les Fundleyter. "These companies are the safest of the safe."

With genetic analysis as its core competency, Sequenom's broader set of tools and services make it an attractive target, because an acquirer can use these capabilities to help translate science into personalized medicine. (The company has also licensed an early-stage but very exciting technology that it hopes will allow whole-genome sequencing for $1,000.)

There are signs that personalized medicine is getting closer. The US recently passed legislation banning discrimination based on genetic information. Meanwhile, pharmacy-benefit manager Medco is working with FDA on the use of genetic tests to understand how individual patients respond to different treatments, and the European Commission has demanded more pharmacoeconomic value in treating specific patient types. In 2008, for the first time, it took the step of approving a drug (Amgen's bowel cancer drug Vectibix) only for a specific genetic variation, determined by a predictive test.

This means Sequenom may be attractive to, say, Roche, which clearly understands the importance of companion diagnostics (witness the Ventana acquisition), or to larger diagnostics firms like Invitrogen, which is seeking deals to bolster its portfolio. As for Stylli, he says he designed Sequenom to work as a stand-alone biz or as a piece of a larger company. "But that couldn't happen today," he says. "We still have a lot of mileage to cover."

Glen Giovannetti, global biotech leader, Ernst & Young: "There's been an awful lot of M&A in diagnostics, and that will continue. As more of this technology is introduced, it's going to force a dialogue on where the value is."

ACORDA THERAPEUTICS

Acquisitions to bolster therapeutic franchises

Growing up, Ron Cohen had two separate but equal passions: acting and medicine. At first, he tried to pursue both. He went to Columbia, the only med school with a full-time dramatics group, and during his residency performed in a community production of The Fantasticks. Ultimately, though, he decided to stick with medicine, figuring that the path forward would be easier—and his parents happier.

After medical school, and early on in the biotech revolution, Cohen decided to join a startup biotech that would come to be called Advanced Tissue Sciences. When he told his parents the news about this new career—that the company he joined was run by some friends of friends and funded by a dentist in Albany—his father, a neurologist himself, had a change of heart. "Son," he asked, "Are you sure you don't want to reconsider a career in acting?"

Indeed, Cohen's life—like the lives of many biotech entrepreneurs—hasn't been easy. He helped take Advanced Tissue Sciences public and get the company's skin drug into the clinic; then he founded Acorda on his own dime. He spent the next 13 years raising money and pushing the lead candidate, fampridine-SR, through clinical trials.


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