Basilea shares plunge on major delay for antibiotic

Shares of Switzerland's Basilea Pharmaceutica were hammered after the developer announced that it faced a major delay in gaining an approval from the FDA for its antibiotic ceftobiprole [1]. In a letter to Johnson & Johnson Pharmaceutical Research and Development, the FDA raised questions about data integrity from its clinical program for the antibiotic. J&J is partnered on the drug [2]. The FDA wants further auditing of its clinical sites and more information on J&J's quality assurance program.

"The drug will probably be delayed by up to 18 months," Birgit Kulhoff, a pharmaceutical analyst in Zurich, said to Dow Jones. Commercialization may have to wait until 2011. And that is not what investors wanted to hear. Basilea's shares plunged 31 percent. And the company's shares are down almost by half from last January. Basilea had been hoping for an approval in the first quarter of 2009.

"We are deeply disappointed with the further delay," said Anthony Man, Basilea's CEO. "We will be working with J&JPRD and the FDA to address these outstanding issues as soon as possible. These events have not altered in any way our confidence in the efficacy and safety profile of ceftobiprole and its potential to satisfy a high medical need."

- here's Basilea's release [3]
- read the Dow Jones report [4]

Related Articles:
Basilea shares plunge on antibiotic delay [1]
FDA cancels meeting as hopes rise for Basilea [5]
Basilea reports positive Phase III antibiotic data [6]
J&J files Ceftobiprole in Switzerland [2]