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The war against superbugs intensifies

06 January 2015 Margaret Labban, Ph.D.

The serious public health threat of microbial resistance is not breaking news, however global efforts to mitigate the impact of this catastrophic yet potentially avoidable situation have notably picked up recently. US President Barack Obama issued an executive order and national strategy to combat antibiotic resistance in September 2014, almost exactly a year after the UK government published its " Five Year Antimicrobial Resistance Strategy".

The World Health Organisation's first surveillance report released in April of this year highlights the ongoing struggle with superbugs, and the dire need to address this issue particularly in developing markets in order to avoid reaching a "post-antibiotic era" where simple medical procedures become very high risk, and infections that were once curable become increasingly deadly.

Results from an economic review commissioned by UK Prime Minister David Cameron have also been announced revealing the startling potential consequences of antimicrobial resistance (AMR). By 2050, an estimated 10 million individuals will die from AMR infections every year surpassing cancer as a cause of death, and costing the global economy a cumulative $100 trillion if the AMR epidemic is not addressed.

I sat down to discuss the superbug threat, and if we are to expect more investment towards drugs to tackle infectious diseases moving forward.

Need for new treatments
The misuse and excessive use of antibiotics has accelerated that rate of bacterial resistance against drugs we have on the market today. As governments, multi-national organisations, and regulators work to impose strict guidelines for appropriate use of antibiotics that could decelerate the prevalence of superbugs, the world is turning to the pharmaceutical industry to help secure a sure-fire victory in this ongoing battle against resistance. The pace at which pharma has advanced new antibiotics to the highly generecised market has lagged considerably; until relatively recently, the fight against infectious disease was generally seen as under control following the development of highly effective antibiotics in the 1970s and 1980s. Hence, antibiotics development was neglected for many years in favour of areas where there seemed to be a much greater need for development.

Incentives for antibiotic development
The tides seem to be turning, and we are seeing considerable investment into anti- from the pharmaceutical industry. In 2014 alone, three new antibiotics have entered the market - Durata Therapeutics' Dalvance (dalbavancin), Cubist Pharmaceuticals' Sivextro (tedizolid phosphate), and The Medicines Co's Orbactiv (oritavancin) all with potency against difficult-to-treat methicillin-resistant Staphylococcus aureus (MRSA) infections. Since then, Durata has been snapped up by Actavis for around $675 million, and Merck & Co made a substantial $9.5 billion acquisition bid for Cubist.

The increased interest is likely a reflection of the notable medical need for new antibiotics, compounded with a favourable regulatory, as well as pricing and reimbursement (P&R) environment that significantly facilitates their development. The FDA has so far granted 39 antibiotic candidates Qualified Infectious Disease Product (QIDP) designations; a status that provides an expedited pathway for clinical development and could prolong market exclusivity for an approved antibiotic by up to ten years among other perks.

While the doomsday scenarios of what could happen cast a shadow on the future, the trajectory set this year with regards to new product development looks promising, and we may very well look back on this time as a key point when a crisis was closely averted.

Margaret Labban is a life sciences analyst for IHS
Posted January 5, 2014



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