Genta's Clinical Quest

In one of the biggest late-stage biotech licensing deals ever, Genta has given Aventis worldwide rights to Genasense. The antisense compound targets Bcl-2, a protein now known to protect cancer cells from death messages. The firms are betting that giving patients this compound in combination with conventional therapies will kill cancer more effectively. The potential is high, but risk remains. Bcl-2 is unproven as a target, and designing clinical trials for two agents is not straightforward. Emerging from a troubled past, Genta initially decided to take the compound to market in the US all on its own. It focused on helping desperately ill patients in small disease indications. Eventually, as encouraging data accumulated, the small firm realized it would be better off partnering. The focused indications that Genta chose, and the way it pursued them, made strategic sense for it-but Aventis aspires to develop the drug against major cancer cancers. The large firm can afford to think bigger: it has more money and resources and the benefit of coming in after Genta laid the groundwork. Both companies are being guided by theories and observations, fully aware that such things mean little to regulators who demand clinical evidence. As befits their respective size and scope, the firms have different approaches to managing the risks of novelty.