Clinical Update (11/2006)
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.
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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.
Benefiting from lessons learned during the more than two decades of futile efforts to develop a sepsis treatment, Lilly is primed to launch the first sepsis therapeutic. Lilly's apparent success reflects a revised view of the disease as multi-factorial in nature, involving not only the body's inflammatory processes--long thought to be at the heart of the disease--but also its interlocking coagulation and clot-busting systems. Zovant's development is also marked by a series of business decisions that could have long-term implications for the company, including a renewed commitment to large molecule drugs and the creation of a critical care business. Critical care pharmaceuticals and protein therapeutics are, in many ways, complementary pursuits for Lilly that could help the company maintain its independence by generating big money products that won't require the huge commercialization costs associated with mass-marketed drugs.