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GEN News Highlights : May 28, 2013

Cempra Wins $58M BARDA Contract

The Biomedical Advanced Research and Development Authority (BARDA) awarded Cempra a five-year contract valued up to $58 million for the development of solithromycin to treat infections in pediatric populations and for the treatment of infections by bioterror threat pathogens. Cempra is a clinical-stage pharmaceutical company focused on developing differentiated antibiotics, and solithromycin is its lead product candidate.

Solithromycin, a fourth-generation macrolide antibiotic in the fluoroketolide family, is currently in Phase III development for community-acquired bacterial pneumonia (CABP) in adults.

The up-front contract is for a two-year base period with guaranteed funding of $17.7 million and is extendable up to five years; if it is extended that far, the value of the total contract would go up to $58 million. The contract is expected to fund activities that are planned to lead to the pediatric as well as the Animal Rule New Drug Applications (NDA) for use of solithromycin against bioterror threat pathogens. The full funding, if received, will support Phase I, Phase II, and the majority of the Phase II/III studies on a pediatric oral suspension, oral capsules, and the intravenous formulation for CABP. The contract should also fund nonhuman primate pilot studies of activity against biothreat pathogens, anthrax, and tularemia.

"Macrolides have traditionally been favored for use in pediatrics because of their safety and efficacy," said Prabhavathi Fernandes, Ph.D., CEO of Cempra. "Solithromycin's approval would be the first orally administered antibiotic approved in decades, and azithromycin (Zithromax® or Z-Pak) was the last macrolide approved, which was in 1991. We view BARDA's funding of this project as recognition of the potential of solithromycin to have broad utility in all age groups."

BARDA is also currently working with GlaxoSmithKline to develop drugs to fight both antibiotic resistance and bioterrorism through an agreement that could be worth up to $200 million should it be renewed over five years.