Basilea Pharmaceutica is non-plussed by the news that European approval for its antibiotic ceftobiprole has been delayed and has filed a claim seeking damages from development partner Johnson & Johnson.
The European Medicines Agency’s Committee for Medicinal Products for Hu
man Use has told J&J that the process for giving full approval for Zevtera (ceftobiprole) for the treatment of complicated skin and soft tissue infections (cSSTI) has been delayed. The CHMP actually issued a positive opinion on the drug in November but now says that it needs to inspect the drug trial sites of Janssen-Cilag, the J&J unit responsible for late development of ceftobiprole.
Basilea said that it has not had written confirmation yet from the EMEA but anticipates that the site inspections will be completed by the second half of this year. This means that approval could be delayed until 2010.
This is a major blow for Basilea, which saw its share price sink 37% on the news. The Swiss firm is so perturbed that it has filed claims against J&J and affiliates to the Netherlands Arbitration Institute related to the delays.
Basilea is demanding damages suffered by the firm that result from the delay in the approval of ceftobiprole in the USA and Europe, as well as milestone payments. Zevtera has faced similar problems across the Atlantic in getting approval and Basilea notes that the problems in the USA have not been issues of safety or efficacy but rather a lack of proper monitoring of the studies.
The US Food and Drug Administration has twice delayed approval, and most recently issued a complete response letter in November demanding a new audit plan that also addresses “deficiencies in contract research organisation monitoring”. As a result of this problem, the agency said it was unable to review the drug further “until issues of data integrity have been resolved”.
The importance of getting some cash rolling in from ceftobiprole became clear as Basilea reported its full results for 2008. Net loss widened 13.2% to 143.5 million Swiss francs while revenues rose to 12 million francs from 8.2 million francs.
The company reported its first product revenues during 2008, following the approval of ceftobiprole in Canada and Switzerland, and of the chronic hand eczema treatment Toctino (alitretinoin) in Germany, UK, Denmark, France and Finland.
