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April 20 — Basilea Pharmaceutica International Ltd. is getting government help to complete development of a broad-spectrum antibiotic to treat drug-resistant infections and bioterrorism threats, the Department of Health and Human Services announced April 20.
The antibiotic, which was developed with support from the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR), could become the first of its kind to treat both specific gram-negative and gram-positive infections as well as the bioterrorism threat tularemia, the HHS said. The agency noted that the antibiotic, ceftobiprole, is an alternative to methicillin, to which some infections have become resistant.
The Centers for Disease Control and Prevention estimates that in the U.S., more than 2 million people are sickened every year by antibiotic-resistant infections, with at least 23,000 dying as a result. In January, the National Institutes of Health announced it was awarding $5 million in funding for 24 research projects to develop non-traditional therapeutics to help address the growing threat of antibiotic resistance (10 LSLR 02, 1/22/16).
Under an 18-month, $20 million agreement between Basilea and the ASPR’s Biomedical Advanced Research and Development Authority (BARDA), the company will conduct phase III clinical studies of ceftobiprole, in treating specific gram-negative and gram-positive infections.
BARDA has the option to extend the agreement for up to four-and-a-half years and could provide up to $100 million in funding. The phase III studies are necessary for Basilea to apply for Food and Drug Administration approval, which Basilea has been seeking for ceftobiprole since 2007.
In addition, the HHS said, Basilea will evaluate ceftobiprole’s potential as a treatment for tularemia, which can cause deadly pneumonia infections and could be used as an agent of bioterrorism.
Gram-positive and gram-negative refer to the two broad classes of bacteria, characterized by how they respond to the Gram staining procedure. The two bacteria types often require treatment with different classes of antibiotics.
The HHS said ceftobiprole is being developed as a potential treatment for skin infections, bloodstream infections and pneumonia, including those caused by methicillin-resistant and methicillin-susceptible Staphylococcus aureus, which are gram-positive. The antibiotic also is being developed to treat infections caused by gram-negative bacteria such as Pseudomonas aeruginosa, which is linked to ventilator-associated pneumonia and sepsis syndrome.
Ceftobiprole was discovered by Basilea, which is based in Basel, Switzerland, and developed by Johnson & Johnson.
The FDA rejected Basilea's application in 2008, citing unreliable data at the study sites. In June 2014, Basilea reported that the FDA was requiring additional phase III clinical data before it would approve ceftobiprole for treating pneumonia. The European Medicines Agency approved Basilea for use in Europe in 2013.
If approved by the FDA, the drug could be marketed commercially for treating the three infections and also could be available for use in a biodefense emergency, the HHS said. Ceftobiprole is the eighth broad-spectrum antimicrobial that BARDA has supported to date, the agency said.
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