Basilea shares ($BSLN) were dented today after the company's half-year report included a note that the FDA isn't backing away from demands for two pivotal studies of its antibiotic ceftobiprole ahead of any marketing decision.
The Basel, Switzerland-based developer has been steaming ahead in Europe, anticipating a final decision on using ceftobiprole to fight pneumonia before the end of this year, with a possible marketing launch in some countries in the second half. "Regarding the U.S.," the company added, "the FDA indicated that their current guidelines mandating two pivotal trials per indication are still valid. Basilea is continuing its discussions with the agency."
That spelled trouble for analysts following the company.
"We are concerned that the FDA is persevering with its guidance of requesting two trials per pneumonia indication," noted Helvea's Olav Zilian, according to a Bloomberg report.
Basilea's shares dropped about 7% on the news.
New incentives have been put in place aimed at encouraging the development of new antibiotics, deemed particularly crucial after Big Pharma distanced itself from the field years ago. But several antibiotics companies in the U.S. still complain about FDA regulations governing development.
- here's the release
- read the Bloomberg report