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insights LIFESCIENCELEADER.COM MARCH 2014 58 PHARMA BUSINESS owever, it didn't take long for the shadow of drug-resistant infections to creep in, and drug developers and physi- cians have been fighting what is now a losing battle against drug-resistant bugs. Unfortunately, creating more antibiotics, whether broad- or narrow-spectrum, is unlikely to solve the problem, as resistance is virtually inevitable. However, the search for a solution in the form of new nonantibi- otic-based approaches is providing a new opportunity, particularly for biotechs and for their future pharma collaborators and partners. These tactics include bacterio- phages (bacteria-killing viruses), and non- bacteriophage proteins, from companies such as Novolytics, AvidBiotics, AmpliPhi Biosciences, and Pherecydes Pharma. FROM ANTIBIOTICS TO THE POST-ANTIBIOTIC ERA In early 2013, Professor Dame Sally Davies, the chief medical officer for England, stated that the danger presented by the growing resistance to antibiotics should be ranked alongside terrorism as a threat to the nation. However, this threat isn't unique to the United Kingdom. In 2013, the first case of a totally drug-resistant infection was discovered; a New Zealand teacher was found to have a bacterial infection resistant to all known forms of antibiotic, probably picked up while teach- ing overseas. What will this mean? There could be deaths from infections following routine operations, especially in the very young and very old, and in people with compro- mised immune systems. Furthermore, it could result in no organ transplants or chemotherapeutics that suppress the immune system. "Broad-spectrum antibiotics have been critical for most surgical procedures and many medical interventions. They have saved many lives and limbs since their launch. However, antibiotic resistance has emerged and has now become ram- pant worldwide," says David Martin, CEO and cofounder of AvidBiotics, a company that generates nonantibody therapeutic and prophylactic proteins that specifically target bacteria. So, if the old antibiotics don't work, then surely the solution is simply to develop new ones, right? Unfortunately, this hasn't worked so far, as shown by the lack of new classes of antibiotics since 1987 when oxazolidinines were introduced. The first of these, linezolid, was discovered in the 1990s and launched in the U.S. in 2000 by Pfizer. However, there were reports of resistance as early as 1999. "The antibiotics industry is well estab- lished, but over the last two to three decades the amount of research effort placed behind new antibiotics has tailed off. Evidence for this comes from the fact that between 1983 and 1987 the FDA approved 16 new antibiotics, but between 2008 and 2012 they approved just two," says John Hardcastle, CEO of Novolytics, a company working to combat antibiotic- resistant bacteria using bacteriophages. Besides the inevitability of resistance, economic forces are also likely to be behind this reduction in antibiotic R&D.; Infectious diseases generally require a short course of treatment, compared with statins or antihypertensives that are used lifelong. And payors expect infectious dis- ease treatments to be low cost. Because resistance can set in quite quickly, antibi- otics also have a limited life. "For good commercial reasons, drug companies have become more focused on chronic diseases, such as depression, cardiovascular disease, diabetes, and can- cer, which is reflected in the top 10 drug revenue statistics published each year," says Hardcastle. Another black mark against broad-spec- NONANTIBIOTICS SPUR BIOTECH-PHARMA COLLABORATIONS By S. Elvidge Nonantibiotics Spur Biotech-Pharma Collaborations S U Z A N N E E L V I D G E Contributing Editor H Since the discovery of penicillin in 1929, the birth of the antimicrobial era meant the beginning of a brave new world, where people no longer died from common bacterial infections, and surgery could be approached with confidence. 0 3 1 4 _ P h a r m a _ B u s i n e s s _ A n t i b i o t i c . i n d d 2 0314_Pharma_Business_Antibiotic.indd 2 2 / 1 9 / 2 0 1 4 2 : 4 4 : 2 5 P M 2/19/2014 2:44:25 PM