Market Access Strategies for Antibiotics Targeting Multidrug-Resistant Gram-Negative Bacteria

Monday 26 August 2013, Amsterdam

Need for Therapies Against MDR Gram-Negative Pathogens Highlights Opportunities for Firms Seeking to Exploit the Marketplace

Since their discovery almost a century ago, antibiotics have revolutionized the global healthcare industry by ushering in an era of significantly reduced morbidity and mortality associated with often-lethal bacterial infections. However, the increasing threat posed by multidrug-resistant (MDRbacteria, in particular gram- negative organisms, has cast a shadow over these remarkable public health achievements. GlobalData’s primary research indicates that this high level of unmet need has generated several opportunities for firms seeking  access  to  the  market.  These  opportunities  include  leveraging  microbiological  diagnostics  to streamline research and development (R&D) and clinical applications, discovering antimicrobial biologics, exploring alternative preclinical testing  environments, enhancing the  activity  of  existing  antibiotics, and utilizing probiotics and  the  natural flora. We expect that  the  increasing rates  of  drug-resistant infections will continue to drive the growth of the antibiotic market in both the US and the 5EU.


Incentive Programs Are Helping Make Antibiotics an Attractive Therapy Area

Many  large  pharmaceutical companies  abandoned  antibiotics  due  to  the  drugs’  risky,  prolonged  R&D process, combined with relatively low prices and short duration of therapy. This has resulted in a stagnant pipeline and has limited the ability of physicians to treat MDR-bacterial infections. The Generating Antibiotic Incentives Now (GAIN) Act, which was passed in the US in 2012, exemplifies an initiative that is intended to drive antibiotic innovation and R&D. Public and private entities are also launching programs to encourage basic research and drug discovery.

The limited variety of current programs is hindering the impact of these initiatives, but we believe that a mixture of push, pull, and hybrid mechanisms will encourage progress throughout all the stages of antibiotic development.


The FDA and EMA Appear Receptive to Aligning Clinical Trial Design and Endpoints to Address Unmet Clinical Needs

According to key opinion leaders (KOLs) interviewed by GlobalData, an outdated and disjointed regulatory landscape across the US and EU has served as a daunting barrier to accessing the marketplace. Given the wide range of indications and pathogens treated by antimicrobial agents, a detailed discussion of indication- specific regulatory requirements is beyond the scope of this report.

Rather, this report focuses on important overarching trends in the regulatory landscape, led primarily by the evolving stances of the Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

Our primary research revealed that both agencies are trending towards increased flexibility, with the goal of better aligning antibiotic approval and labeling mechanisms with unmet medical need. Steps towards this goal include more pragmatic clinical trial endpoints and enrollment criteria, the active engagement of sponsors, and establishing regulatory accord across the US and Europe regarding approval criteria (for example, the Transatlantic Taskforce on Antimicrobial Resistance TATFAR). GlobalData believes that firms seeking to enter the market must foster continuous dialogue with the FDA and EMA in order to streamline the clinical development process.


Antibiotic R&D Requires a Partnership Approach

We believe that the disappearance of Big Pharma from antibiotic R&D is due to the failure of the traditional business model, where a single company would discover, develop, and launch an antibiotic. Given the current state of the market and declining revenue streams associated with antibacterials, the risks associated with this type of venture are no longer justified. We believe that a “partnership approach,” where financial risk is distributed among multiple stakeholders by incentivizing larger companies back into the field through public-private partnerships (PPPs), represents a realistic, balanced approach to the development of novel antibiotics.

In this collaborative model, Big Pharma will foster relationships with academic labs and small and medium enterprises (SMEs) to conduct early-stage R&D, predominantly discovery and preclinical studies, while leveraging its own late-stage R&D expertise to more efficiently push drug candidates through clinical trials. GlobalData also expects incentive programs, such as the GAIN Act and the Biomedical Advanced Research and Development Authority (BARDA), to help facilitate this shift away from the traditional R&D approach. Importantly, financial backing from governments will play a role in all stages of the R&D process. GlobalData believes that PPPs will be a key driver of the MDR gram-negative market in the US and EU, replacing blockbuster drugs with more niche products that possess more modest returns on investment (ROIs), but address clinical unmet needs.