New antibiotic drug delayed

New antibiotic drug delayed

3rd March 2009, Comments 0 comments

A Swiss drugs firm files claims against Johnson & Johnson for delaying ceftobiprole, an antibiotic for dangerous skin infections.

TRENTON — Johnson & Johnson's experimental antibiotic for dangerous skin infections had two more setbacks — a delay from European regulators, followed by legal action from its Swiss partner in developing the drug.

New Brunswick, New Jersey-based Johnson & Johnson long publicised ceftobiprole as a promising treatment for complicated skin and soft tissue infections, including MRSA, a deadly drug-resistant staph germ.

But the Food and Drug Administration twice delayed approval, most recently saying it wants more audit work done at clinical-investigator sites and answers to questions related to the monitoring done at these sites, where the drug was tested on patients.

In late February, Johnson & Johnson's Jansen-Cilag International NV unit said that the Committee for Medicinal Products for Human Use, an advisory panel of the European Medicines Agency, delayed approval pending completion of what's called a "good clinical practice inspection".

That mainly involves reviewing records at the European hospitals and other sites where patient testing was conducted, said J&J spokesman Ernie Knewitz.

On Tuesday, Basel, Switzerland-based Basilea Pharmaceutica, claiming financial damages from the repeated delays, submitted a request for arbitration to the Netherlands Arbitration Institute. A company statement said the arbitration request also involves milestone payments.

"In this environment, for small biotechs, any delay is absolutely devastating," said analyst Steve Brozak of WBB Securities.

"What is absolutely essential for" Basilea is just one of many projects for Johnson & Johnson, he added.

The company said it could win approval of seven other new drugs in 2009 alone.

Basilea, which discovered ceftobiprole, granted Johnson & Johnson an exclusive worldwide license in 2005 for the drug, which would be sold under the brand name Zevtera in European Union countries.

The company applied for approval to sell the drug in the European Union in June 2007. The advisory committee recommended approval in November 2008, but the committee halted the EU process until it finishes inspections.

Basilea said in a statement that it expects both that process, and submission of the new information requested by the FDA, to be completed in the second half of 2009.

"Given the paucity of new antibiotics on the horizon, it's not a question of if it will be approved, it's a question of when," Brozak said.

In 2008, ceftobiprole was approved in Switzerland, Canada and Ukraine. Basilea also has a dermatology drug, alitretinoin, on the market.

Johnson & Johnson, on the other hand, is the world's most broad-based health care company, with nearly USD 64 billion (CHF 75 billion) in annual revenue.

Still, Brozak said, "there is potential blowback" for Johnson & Johnson, which is steadily buying other companies and does not want to acquire a reputation as difficult to deal with for small companies.

Text: Linda A. Johnson / AP / Expatica 2009

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