Emerging Drug Developer: Flexion Therapeutics

A ruthless pursuit of the bold experiment

Mike Clayman and Neil Bodick are no strangers to the development process. Together they founded Chorus, Eli Lilly's in-house, early-stage development group, which was charged with finding the shortest path possible to proof-of-concept data. And they've garnered $33 million from a Series A to finance their own start-up development outfit, bringing all the skills they've learned along the way to advance therapies taken off the shelves of Big Pharma's R&D operations.

"Large pharma is frequently in a position of putting things on the shelf," says Clayman, the CEO at Flexion Therapeutics. "Every large pharma has molecules that they would be interested in moving to proof-of-concept.

"In a little over a year, we looked at over 130 molecules from large pharma," he says.

"We have good networks--our own contacts, venture contacts. Drugs are on the shelf that aren't even being shopped. There's a whole universe of opportunity out there. And I believe that Phase I and II typically gets squeezed in a large organization. "

Flexion has adopted a simple strategy. The start-up plans to acquire a license for the therapies they add to their pipeline, says Clayman. But it's also possible that the company could do a deal where it in-licenses a batch of experimental therapies with an option to return one in the event the proof-of-concept data is compelling--with a success fee, milestones and downstream royalties as a payoff.

For now, the company has a core team of eight people running Flexion. The new financing gives the developer the money to expand that staff, with plans to hire 12 to 15 people by the end of next year.

"Our goal is to hire outstanding, deeply expert and experienced people," says Clayman, "while keeping our numbers as small as possible." Most of the money will be spent generating data. "For each project we'd have an internal team who would oversee it," while reaching out to CROs to get the work done.

What makes Flexion credible, and won over the backing of Versant Ventures along with 5AM Ventures and Sofinnova Partners, is the development history of the company's two founders. Bodick, Flexion's COO, gained a high-profile reputation as COO at Eli Lilly's Chorus, a skunkworks program in which 22 people honed their skills at swiftly advancing new drugs to proof-of-concept at a record speed. Clayman was president of Chorus and they both took an early retirement to go out on their own.

"It normally takes about four years and up to $40 million to reach clinical proof of concept," Rafaèle Tordjman, a partner with Sofinnova Partners, said when the company announced its Series A in October. "Flexion can reach that all-important milestone in about half the time and an eighth of the cost. That is an outstanding achievement and a paradigm shift in terms of productivity for the pharmaceutical industry."

"We're going to large pharma and saying, ‘We're proposing to do with your molecule what Lilly did," says Clayman. "I would submit that what Neil and I have is a ruthless pursuit of the bold experiment that will define the value of a molecule."

They'll soon get a chance to prove it. Flexion's release notes that the developer expects to announce some development pacts with pharma companies in the near-term, and the new round gives them the money to move quickly.

Before Flexion reaches its first set of proof of concept data, Clayman and Bodick have some serious thinking to do about what kind of company Flexion can grow into.

"We're completely prepared for late-stage programs," says Clayman, who can see Flexion "advancing to Phase III and beyond. It's an evolution," he adds, "and it's under active consideration."

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Emerging Drug Developer: Flexion Therapeutics