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to do most of the work on its four drug candidates through contract research organizations. Flexion isn’t saying much specifically about the individual molecules it has obtained, but these molecules have a few things in common, Clayman says. They are targeting inflammatory diseases that represent unmet medical needs, they could be commercialized with a small and specialized sales force that a company like Flexion could build, and they are already in early clinical trials or on the verge of clinical trials, Clayman says.
The plan will be to run randomized, placebo-controlled studies at a range of doses to give Flexion a clear answer on whether a drug can truly generate the “proof of concept” data needed to run a pivotal Phase III program with confidence, he says.
The business model for Flexion is pretty malleable. The deals are structured in two basic ways, Clayman says. One essentially provides Flexion with full ownership rights. The other gives Flexion full ownership in the beginning while allowing the originating company a chance to opt-in later for co-development after a candidate reaches proof of concept.
Clayman wouldn’t disclose which companies got which terms. But in the latter deals, the big drugmakers are essentially getting “a cost-free option to look at proof of concept data” for molecules they invented, while giving up a “significant portion” of the ownership rights to Flexion. The first clinical trials to test these drugs should be up and running by the end of this year, with the first proof of concept data arriving by late 2011, Clayman says.
“Doing these deals and raising $42 million in our Series A is really a validation of our model and the value we think we can create,” he says.
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