Cubist, like other companies in the anti-infectives space, was founded on the assumption that anti-infective drugs entering the clinic had a significantly lower risk of failure than other therapeutics. That risk profile may be changing because of the FDA's imposition of stricter standards for the approval of anti-microbials. So far, Cubist has met that challenge with respect to daptomycin, the Phase III antibiotic that would be the company's first marketed product. Yet, a cloud of regulatory uncertainty still lingers. But through aggressive dealmaking, Cubist has built a discovery and development pipeline that helps to balance the risk that daptomycin may run into unexpected roadblocks on the way to approval.
By Jeffrey Dvorin
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