Basilea has announced that BARDA, a division of the US Department of Health & Human Services Office, has awarded a contract of up to $100m for the Phase III development of antibacterial agent ceftobiprole (Zevtera) for the US market. Critically, this means that the Phase III trials in skin and bacteraemia (blood) infections could start as soon as late 2016/early 2017 once the company has agreed the Phase III study Special Protocol Assessments (SPAs) with the FDA. The BARDA contract now removes the uncertainty in timing for the Phase III clinical trial programme that would support Zevtera’s US regulatory filing. We value Basilea at CHF1,114m or CHF103.2/share.

22 Apr 2016
Zevtera US development full steam ahead

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Zevtera US development full steam ahead
Basilea Pharmaceutica AG (BSLN:SWX) | 0 0 0.0%
- Published:
22 Apr 2016 -
Author:
Dr Susie Jana -
Pages:
5 -
Basilea has announced that BARDA, a division of the US Department of Health & Human Services Office, has awarded a contract of up to $100m for the Phase III development of antibacterial agent ceftobiprole (Zevtera) for the US market. Critically, this means that the Phase III trials in skin and bacteraemia (blood) infections could start as soon as late 2016/early 2017 once the company has agreed the Phase III study Special Protocol Assessments (SPAs) with the FDA. The BARDA contract now removes the uncertainty in timing for the Phase III clinical trial programme that would support Zevtera’s US regulatory filing. We value Basilea at CHF1,114m or CHF103.2/share.