Antibiotics development is about to get a needed boost with the release of new federal proposals aimed at curbing rising antibacterial-resistant infections caused by so-called superbugs.
|President Barack Obama|
The recommendations, put forth by the President's Council of Advisors on Science and Technology (PCAST), include ways to speed drug development of new antibiotics and make clinical trials of these drugs more efficient in light of a dried-up global pipeline. Coinciding with an executive order signed yesterday, the proposals--if adopted--could help lure companies back to the challenging field.
One proposal that would affect small biotechs and Big Pharma alike is the creation of a "robust, standing national clinical trials network for antibiotic testing" that would be able to quickly enroll patients with dangerous bacterial infections. A benefit of such a network is that it would be able to test multiple new agents from different sponsors that could be evaluated simultaneously for their safety and efficacy.
The report, drafted by an outside panel of industry and academic experts, also pushes for approval of antimicrobial agents for use in limited patient populations so that people suffering from severe infections could benefit as quickly as possible from new drugs. The advisory group also wants to establish a Special Medical Use (SMU) pathway to help the FDA deliver such limited-use drugs to the market faster.
The steep R&D costs associated with antibiotics have largely driven away the industry in recent years, but PCAST also wants to fix that. To spur more development activity in the antibiotics arena, the advisory group is proposing economic incentives with particular attention to new classes of antibiotics.
Only a few major players--including Roche ($RHHBY), Cubist Pharmaceuticals ($CBST), Basilea Pharmaceutica ($BSLN) and Otsuka--are doing late-stage work in antibiotics right now.
"While there is a pressing need for new antibiotics, economic, regulatory and scientific circumstances make their development challenging for companies and have caused many to exit the space," Cubist Pharmaceuticals said in a statement in response to the executive order and PCAST report.
President Barack Obama's executive order also included a $20 million prize to drive the development of new diagnostic tests to identify highly resistant bacterial infections.
Editor's Corner: Cubist exec: Challenges mount in antibiotics discovery