Johnson & Johnson terminated a partnership to develop a highly touted drug for MRSA and other dangerous skin infections after European regulators rejected it over concerns that testing data isn’t reliable.
Switzerland’s Basilea Pharmaceutica Ltd. discovered the compound, called ceftobiprole. The company had been J&J’s partner since granting the world’s largest maker of health care products an exclusive worldwide license for it four years ago.
But on Friday, Basel-based Basilea said the European Committee for Medicinal Products for Human Use refused to approve the drug, and Basilea regained full, global rights to it after J&J backed out of their deal. It said there would be a transition period to ensure proper management of ongoing testing, manufacturing and other activities “at no cost to Basilea.”
J&J shares dipped 2 cents to $64.02 in midday trading. Basilea shares jumped 11.4 percent to 74.50 Swiss francs in Swiss trading.
Questions about the quality of clinical testing of the drug surfaced more than a year ago, and an arbitration process Basilea started to recover damages from J&J, based in New Brunswick, N.J., is ongoing.
Last August, the U.S. Food and Drug Administration sent Johnson & Johnson a warning letter, stating “there was a failure to ensure proper monitoring of the studies as well as deficiencies in study conduct.”
The European advisory committee, known by the acronym CHMP, had recommended in November 2008 that ceftobiprole be approved for use in the European Union, releasing what’s called a “positive opinion.”
However, the European Medicines Agency later took the unusual step of stopping the authorization process to review the quality and monitoring of human tests at hospitals and other sites around the world.
Basilea said in a release that CHMP notified it the inspections found the final-stage human studies on which the approval application was based “had not been conducted in compliance with (those rules) in some sites.”
“The CHMP indicated that, although the study results suggest that the medicine was beneficial to patients, it was concerned about how reliable the results were,” Basilea said in a statement. “The committee therefore recommended that, in light of the uncertainty surrounding the results, ceftobiprole should not be granted marketing authorization.”
The drug, which would be known by the brand name Zeftera, or Zevtera in Europe, has been approved in Canada and a couple of other countries.
Basilea and a Johnson & Johnson unit called Janssen-Cilag first applied to European regulators in June 2007 for approval of the drug, which J&J executives had long been touting to analysts.
The collapse of the deal could lead to Basilea becoming a takeover target.
Date: February 19, 2010
Source: Associated Press
Filed Under: Drug Discovery