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PFIZER LOOKING HIGH AND LOW Researchers continue to exploit natural products in their search for novel antibiotics. AN UPHILL BATTLE With short lives and uncertain profits, antibiotics are a unique DEVELOPMENT CHALLENGE for drug companies LISA M. JARVIS, C&EN NORTHEAST NEWS BUREAU IN THE EARLY 1990s, Eli Lilly & Co. put out to pasture a compound that had once held great promise as the first of a new class of antibiotics. Daptomycin, a lipopeptide discovered in a soil sample taken from Turkey’s Mount Ararat, was just too challenging to bother pursuing any further. The problem was that, despite signs of activity, the drug wasn’t very potent. But when clinicians turned the dosage up or administered the drug more often, trial volunteers developed muscle damage. The therapeutic window—the range in which a drug can be given safely and effectively— was simply too narrow. Lilly had decades of experience developing antibiotics; from the 1940s through the 1960s, it had introduced the seminal drugs erythromycin, vancomycin, and cephalosporin to the market. But for daptomycin, scientists just couldn’t find a path forward that made sense, says Barry I. Eisenstein, who was vice president of Lilly Research COVER STORY Laboratories and head of infectious disease research at the company from 1992 to 1996. The fact that Lilly already marketed vancomycin, a broad-spectrum antibiotic that was considered the gold standard of care at the time, made the decision to scrap the drug easier. Good options to treat infections were already out there. Why waste more time on a drug that would compete with a company breadwinner? Daptomycin was shelved, and a few years later Lilly got out of antibiotics research altogether. In fact, the mid- to late- 1990s was marked by a mass exodus of big pharma firms from antibiotics R&D. The market seemed sated, and research was too slow and financially unrewarding. And yet a decade later, a clear need for new compounds has arisen. Only two novel classes of antibiotics have been introduced MORE ONLINE WWW.CEN-ONLINE.ORG 15 APRIL 14, 2008 in the past 40 years: oxazolidinones and lipopeptides. And the overall number of new, approved antibiotics—almost all members of known classes—has steadily declined, according to the Infectious Diseases Society of America. Meanwhile, several strains of bacteria have outwitted vancomycin and other key antibiotics, leaving doctors with few options to combat what are often referred to as “superbugs.” Methicillin-resistant Staphylococcus aureus (MRSA), in particular, has made headlines because of its alarming ability to strike otherwise healthy people. Thus the conundrum in antibiotics research: Companies aren’t motivated to look for novel drugs in a category that for years was fairly well supplied and not very lucrative. At the same time, bacteria have a crafty way of rendering existing drugs Learn about how tougher FDA approval regulations are affecting developers of new antibiotics; go to www.cen-online.org.
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