Cubist: The Virtues of Pipeline Diversification
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.
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Peptide Therapeutics' Rising Tide
As emerging technologies begin to overcome peptide therapeutics’ pharmacologic limitations, their compelling potential grows clearer and their deal value has grown. Most if not all of Big Pharma and Big Biotech now have rebuilt their internal peptide drug development programs and show interest in start-ups with peptide pipelines and platforms.
Antibacterials: Biotechs Fill the Big Pharma Void
Big Pharma may have abandoned anti-bacterial research some years ago, but biotechs are filling the void. Their approaches range from improving existing drugs to discovering entirely new targets. Yet although a handful in Europe, including recently floated Basilea and private firm Arrow, has attracted recent investor interest, it hasn't been the anti-bacterials per se that have drawn them in. Basilea benefited from its spin-off status; Arrow from a promising anti-viral project and broad portfolio. Despite growing concerns over bacterial resistance, the field needs success stories to draw investors back for good. Even then, the nature of the diseases and therapies under development mean it's likely to remain the domain of smaller firms.
A Hospital Antibiotic's Closely Watched Launch
Cubist ultimately wants its new hospital antibiotic Cubicin to replace the widely used vancomycin. To do that, it's got to demonstrate that Cubicin, recently approved for a single indication, is safe and effective for a broad spectrum of hard-to-treat infections. As the first company in four years to launch a new hospital antibiotic, Cubist may be a model for the handful of other small companies seeking to capitalize on the opportunity. These start-ups may be better suited than Big Pharma to address what experts see as an important but limited unmet medical need.