While Big Pharma still has a strong foothold in the antibiotics market, smaller biotechs have tackled the job of replenishing our arsenal of new weapons against infections--especially so-called superbugs, like MRSA, that are resistant to older antibiotics.
Despite those drug-resistant infections, there's been a dearth of FDA approvals of new antibiotics in recent years. San Diego-based Optimer Pharmaceuticals ($OPTR) has a shot to bring a new antibiotic to market this year if the FDA approves its application for marketing Dificid to treat intestinal infections later this month. And over the next three years or so, several others such as Cubist Pharmaceuticals ($CBST), Trius Therapeutics ($TCRX), The Medicines Co. ($MDCO), Paratek Pharmaceuticals and Durata Therapeutics are also expected to be in the running to get U.S. approval for new antibiotics, Bloomberg reports.
Yet let's not forget why Big Pharma seems to have taken a backseat in antibiotic development. Antibiotics don't generally bring in as much money as some drugs that patients take for chronic diseases, in part because doctors take patients off antibiotics once their infections are cleared. So it's not like taking a diabetes drug like Actos for years. Also, regulators have shown that they are not going to give antibiotic developers much or any slack in the regulatory process. The FDA, for example, shot down former Cambridge, MA-based Targanta Therapeutics' application for an antibiotic to treat skin infections called oritavancin in late 2008 because it wanted to see more late-stage data. The Medicines Co. took over the program on the cheap for $42 million in 2009 and has been conducting the necessary late-stage studies of oritavancin in the hopes of gaining FDA approval in 2013.
Still, Lexington, MA-based Cubist is a great example of how Big Pharma's loss can be biotech's gain in the antibiotic market. The company's lead antibiotic for skin infections, Cubicin, hauled in just shy of $600 million last year and has served as the company's foundation for building its pipeline. What some people might not remember is Cubist grabbed rights to Cubicin during its development in the 1990s from Eli Lilly ($LLY), which pivoted away from the product like so many other large drugmakers have done with other antibiotic candidates.
"Pharma abandoned the antibiotic space because they didn't think there was enough of a revenue opportunity," Alan Carr, an analyst at Needham & Co., told Bloomberg. "A smaller, more manageable product with revenue under $1 billion is fine for a biotech company."
- read Bloomberg's report