ceftobiprole

Basilea shares plunge on major delay for antibiotic

John Carroll — Wed, 26 Nov 2008 08:51:35 -0500

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. 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. 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
- read the Dow Jones report

Basilea shares plunge on antibiotic delay

Tue, 18 Mar 2008 07:59:58 -0400

Switzerland's Basilea took its turn on the public markets' whipping post, shedding 27 percent of share value after announcing that its antibiotic ceftobiprole had failed to quickly win over FDA regulators. The agency said that it would need more information on the antibiotic--which is partnered with Johnson & Johnson. In an approvable letter, the FDA outlined its requirements: more information on the drug's impact on diabetic foot infections, more time to assess the data submitted, and a review of the study sites used to test the therapy. Ceftobiprole is intended to treat complicated skin infections, including MRSA.

In a phone call with analysts, Basilea CEO Anthony Man declined to offer a timeline for an approval, but noted that the agency isn't asking for more studies. Researchers are also testing the drug as a possible therapy for pneumonia.

While analysts suggested that a 9 to 12-month delay was likely, at least one was pleased to see that the FDA was willing to go with Basilea's non-inferiority trial, which could have proved to be a sticking point.

- here's the release
- read the article from MarketWatch

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FDA cancels meeting as hopes rise for Basilea

Wed, 13 Feb 2008 06:59:58 -0500

The FDA has canceled a scheduled advisory board meeting on Basilea's ceftobiprole antibiotic, a move that analysts say makes a quick approval likely. That's what investors wanted to believe, sending shares of Basilea up in hopes that the agency will move swiftly. The FDA, though, gave no reason for the cancellation and the company declined to speculate on what it could mean. The agency granted a standard review of the antibiotic in July.

"Normally, the process takes about ten months," said a spokesperson. "The treatment application was accepted in mid-July." Drug developers have been scrambling to come up with new treatments for MRSA and other infections that have been spreading quickly. But several big companies also exited the antibiotic field several years ago, making it harder to find deep-pocket partners to advance new therapies.

- see this release
- here's the report from AFX

Related Articles:
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Basilea reports positive Phase III antibiotic data

Tue, 09 Oct 2007 06:59:58 -0400

A late-stage trial of the experimental antibiotic ceftobiprole, which is being jointly developed by Basilea and J&J, has demonstrated significant results, with 86 percent of patients being cured of diabetic foot infections. The therapy, which is under review at the FDA, also demonstrated signs of success against antibiotic-resistant bacteria, or Staphylococcus aureus. Researchers unveiled the data at the Infectious Disease Society of America meeting in San Diego.

"Diabetic foot infections are becoming increasingly difficult to treat," said study author, Gary J. Noel, M.D., with Johnson & Johnson Pharmaceutical Research & Development. "These data suggest that ceftobiprole may be useful as stand-alone therapy for this increasingly common type of complicated skin infection."

- check out the release for more info

Related Articles:
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Basilea gets fast track for antifungal drug. Report
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