BioCentury
ARTICLE | Company News

Basilea lands BARDA contract for ceftobiprole

April 21, 2016 1:17 AM UTC

Basilea Pharmaceutica AG (SIX:BSLN) said HHS's Biomedical Advanced Research and Development Authority awarded it a 4.5-year contract potentially worth $100 million to support Phase III trials of the company's ceftobiprole medocaril. Basilea markets the broad-spectrum cephalosporin antibiotic in Europe as Zevtera.

Basilea will first receive about $20 million over 18 months. BARDA may exercise additional options over the subsequent three years. Basilea hopes to obtain SPAs from FDA for three Phase III trials it intends to start by early 2017. The studies would be designed to support NDAs for ceftobiprole to treat Staphylococcus aureus bacteremia (SAB), acute bacterial skin and skin structure infections (ABSSSIs) and community-acquired bacterial pneumonia (CABP). The antibiotic has Qualified Infectious Disease Product (QIDP) designation from FDA for the latter two indications. ...