In Sepsis, Having the Right Drug Still May Not Be Enough
In conjunction with the initial sales numbers for its sepsis drug, Xigris, manufacturer Eli Lilly cautioned that "the selection of patients with severe sepsis as indicated on the label has been complex for physicians initially." To address the knowledge gap, the National Institutes of Health has awarded a $6 million grant for a study of risk factors for sepsis, the first study of its kind and the biggest single R1 grant ever funded through NIH's National Institute of General Medical Sciences. The Xigris pivotal trial was the only one of 31 Phase III trials of sepsis drugs that didn't fail. "It's not just understanding how the drug works, it's believing in it," says the principal investigator for the NIH study, which should help move the process forward.
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Short summaries of notable clinical findings impacting the device industry; sepsis gets a new ProCESS; antibiotic-resistant bacteria, and computer automation reduces time on ventilator.
Eli Lilly hopes that renewed focus on patient selection and a practical message targeted at a variety of hospital personnel--not just prescribers--can boost disappointing sales of its severe sepsis treatment, Xigris, as it gears up to launch the expensive treatment in the price-conscious and heterogeneous European market.
At a time when the pharmaceutical industry is desperately looking for ways to increase productivity and fatten pipelines, it would only seem sensible for drug companies to maximize their opportunities by creating substantial large molecule capabilities. But even with the renewed interest in monoclonal antibodies, there's little evidence that more than a few major drug companies have made a serious commitment to macromolecule drug discovery and development. Some industry observers contend that companies failing to make such a commitment do so at considerable peril. On the other hand, new technologies may help to make large molecules easier, cheaper, and thus more palatable for drug firms to work with. The question is whether those companies caught up in the small molecule paradigm will seize the opportunity before being left in the dust by those already focusing on macromolecules.