DUBLIN--(BUSINESS WIRE)--Research and Markets (http://www.researchandmarkets.com/research/63hx39/pharmafocus) has announced the addition of the "PharmaFocus: Market Access Strategies for Antibiotics Targeting Multidrug-Resistant Gram-Negative Bacteria" report to their offering.
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 (MDR) bacteria, in particular gram-negative organisms, has cast a shadow over these remarkable public health achievements.
The authors'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. The authors expects 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 The authors believes 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 The authors, 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).
The authors's 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]). The authors 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.
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