"Biotech companies like us can fill the void that's been created by the exit of the big pharmaceutical companies," said Dr. Francis Tally, chief scientific officer at Cubist Pharmaceuticals in Lexington, Mass. "$300 [million] to $400 million in sales won't cut it with big pharmaceutical companies."
Cubist has developed Cubicin, one of the only antimicrobials (drugs specifically targeting microorganisms) to come to market in many years. Initial research on the drug was started in the 1980s by pharmaceutical giant Eli Lilly, which abandoned research efforts on the drug in 1991 but now has a licensing agreement with Cubist.
"The only two new [antimicrobial] drugs in 25 years are Cubicin and Zyvox," Tally said. "And both of these new ones were discovered about 25 years ago."
Pfizer, maker of Zyvox, is one of the only large drug manufacturers that has increased its research efforts in antimicrobials.
"We had around 40 people working in this area -- now we have over 160," said Martin Mackay, senior vice president of worldwide research and technology for Pfizer. "We've mounted a substantial campaign in this area. Our size gives us this benefit."
But Mackay acknowledges the challenges of antibiotic research are significant. One of the most frustrating problems is the ability of bacteria to mutate and develop drug-resistant strains, confounding the best efforts of medical researchers.
"We're in a constant fight with bacteria," Mackay said. "Just when you think you're ahead of the game, lo and behold, 10 years later you're back in the fight again."
"Infectious diseases mutate, so if you work on [a drug] for 20 years, by the time you get it out the door, it's a different disease," added Robins.
The Infectious Diseases Society of America has issued a report entitled "Bad Bugs, No Drugs" that highlights the alarm among some medical professionals and government officials.
The report, issued in July, cites a study from the May issue of the journal Clinical Infectious Diseases that found 506 new drugs in development, but only five were antibiotics, due in large part to the number of companies withdrawing from antibiotic research.
And many of the antibiotics in development are "broad-spectrum" antibiotics, intended to combat a wide range of disease-causing organisms. The use of broad-spectrum antibiotics has been cited as a leading cause of the emergence of antibiotic-resistant bacteria.
In 2003, partly as a result of efforts by the IDSA and others, Sens. Orrin Hatch, R-Utah, and Joseph Lieberman, D-Conn., introduced legislation designed to spur investment by major drug companies in antibiotic research and development.
The legislation, often referred to as BioShield II, seeks to implement a number of incentives to drug companies including tax incentives, liability protection, patent extensions and small business grants.
"The first issue to be addressed is what anti-infectives will be included in Bioshield II, and what kind of disincentives can be removed," said Edwards, one of the authors of the 2004 IDSA report.
The FDA is also looking at ways to facilitate the introduction of new antibiotics.