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Cubicin: Spearheading Chiron's Biopharma Push in Europe

Executive Summary

Antibiotic Cubicin, which Chiron expects to file for European approval before year end, is key to the US group's biopharma push in Europe. New EMEA guidelines on anti-infectives may ease the drug's passage onto the European market. But it will still face stiff competition from other new anti-bacterials, most without the legacy of toxicity concerns that have dogged Cubicin.

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Prolysis Ltd.

Prolysis Ltd. reckons it has a head start over other biotechs seeking novel anti-infectives because its core technology--a series of whole cell assays targeting critical bacterial pathways--allows it to select, early on, only those compounds that get inside the bacterial cell.

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.

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