Increased Government Efforts Aim to Reinvigorate a Stagnant Antibiotics Market
Christopher Pace, PhD, GlobalData’s Analyst covering Infectious Diseases, says “On July 1, 2014, UK Prime Minister David Cameron revealed the formation of an independent review panel to address the growing threat of antibiotic resistance. Mr. Cameron’s claim that inaction will result in “an almost unthinkable scenario where antibiotics no longer work and we are cast back into the dark ages of medicine” is a valid conclusion that has been echoed by experts interviewed by GlobalData. Over the last two decades, many large pharmaceutical companies have abandoned antibiotic research due to the risky and prolonged research and development (R&D) process, combined with the difficulty in commanding premium-pricing and the short durations of therapy.
“The clear need for novel antibiotics and increased stewardship initiatives has led governments and regulatory bodies across the European Union (EU) to step up their efforts in bringing the pharmaceutical industry back to the antibiotics table. For example, Europe’s COMBACTE program, funded by the Innovative Medicines Initiative (IMI), fosters collaboration between public and private organizations, with the goal of streamlining antibiotic clinical trial design and implementation, while the IMI’s TRANSLOCATION program seeks to gain a better understanding of drug permeability into gram-negative bacteria. These efforts, along with an increased willingness of the European Medicines Agency (EMA) to engage in discussions surrounding antibiotic clinical trial design and relevant endpoints, have begun to entice drug developers back into the antibiotics space.
“In the US, the Food and Drug Administration (FDA) is also tackling head-on the issue of antibiotic resistance through the Generating Antibiotic Incentives Now (GAIN) Act. The GAIN Act aims to stimulate antibiotic R&D through economic incentives, most notably Fast-Track regulatory review and five additional years of market exclusivity for pipeline agents that are designated as Qualified Infectious Disease Products (QIDPs). Any pipeline products that target antibiotic-resistant bacteria, such as methicillin-resistant Staphylococcus aureus (MRSA), Acinetobacter, Klebsiella, Pseudomonas and E. coli, are eligible to receive the coveted QIDP designation. The recent approvals of two QIDP recipients – Durata Therapeutics’ Dalvance (dalbavancin) and Cubist Pharmaceuticals’ Sivextro (tedizolid phosphate) – demonstrate that the GAIN Act is already producing results, and with approximately 20 drugs being awarded QIDP status to date, GlobalData expects more approvals to come over the coming years.”
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