By James DeGiulio --
Over the past five years, the pharmaceutical industry seems to have had little interest in developing new antibiotics despite drug-resistant bacteria representing a serious public health issue. Since the appearance of the first antibiotic-resistant bacterial strains in the 1940's, at least thirteen strains that are impervious to many antibiotics have been discovered. According to the Infectious Disease Society of America, bacteria that are resistant to one or more drugs are responsible for some 100,000 U.S. hospital deaths a year, and cost the health care system more than $34 billion. According to a recent Bloomberg report, however, smaller biotech firms may be assuming the role normally occupied by large pharmaceutical companies, and stepping up to develop new classes of antibiotics.
Due to lack of expected revenue opportunity, the pharmaceutical industry has all but abandoned the development of new antibiotics. While important for quality medical care, antibiotics rarely provide blockbuster potential to a pharmaceutical company. Because antibiotics are used for only weeks at a time, as compared with years for drugs that treat chronic diseases, the revenue stream for antibiotics is not long-term. Furthermore, physicians are advised to limit antibiotic treatment because of concerns that overuse can spur resistance, which can have a negative effect on sales. This removes incentives to spend funds on research and regulatory approval for new antibiotics. Indeed, since 2006, only three of 111 drugs approved by the FDA were antibiotics, and only two of the top six drugmakers are currently developing antibiotics. The top five antibiotics earned a relatively modest combined $6 billion in 2010 in the U.S.
Despite this antibiotic apathy among big industry players, there is certainly a public health need for developing new antibiotics. For patients hospitalized with skin infections, for example, it is reported that about 20 percent will not respond to first-choice treatment with clindamycin or Bactrim. For these patients, the hospital has two options, both of which are much more expensive than clindamycin or Bactrim treatment: a 10-day course of Pfizer's Zyvox, which costs about $1,000, or alternatively, an intravenous drug like vancomycin can be used, which requires a hospital stay.
Smaller biotech companies are beginning to fill the void left by the lack of interest in new antibiotics by big pharma. Smaller companies do not necessarily need a blockbuster drug to flourish, and antibiotics present a manageable product. Some of the early entrants are already projecting solid returns on their efforts. Optimer, a San Diego-based company, is nearing approval for Dificid, a drug that fights stomach infections, which is expected to generate $500 million a year in sales. The Medicines Co., of Parsippany, New Jersey, is developing oritavancin, a skin infection antibiotic which is expected to generate as much as $300 million. Other companies in final testing of drugs that may gain U.S. marketing approval by 2014 include Paratek Pharmaceuticals Inc. (omadacycline, an injectable derivative of tetracycline), Cubist Pharmaceuticals Inc. (drug targeting pneumonia, abdominal and urinary tract infections caused by gram-negative bacteria), and Durata Therapeutics (dalbavancin, a lipoglycopeptide that breaks down the cell walls and membranes of bacteria).