Swiss biotechnology company Basilea Pharmaceutica says that partner Janssen Cilag, a unit of Johnson & Johnson, has filed its broad-spectrum antibiotic ceftobiprole for marketing approval in Switzerland.
The submission to the healthcare regulator Swissmedic, which had previously granted the drug a fast-track assessment, is for the use of ceftobiprole in the treatment of complicated skin and soft tissue infections, including diabetic foot infections. The drug, which has already been filed for approval in the USA, Canada and the European Union, is the first broad-spectrum cephalosporin to show efficacy in a large clinical trial against methicillin-resistant Staphylococcus aureus (MRSA) and demonstrated clinical activity against Gram-positive as well as Gram-negative pathogens.
The news of the Swiss filing came as Basilea posted a net loss of 64.4 million francs, around $53.4 million, for the first half of 2007, which is an increase of 61.8% but was in line with expectations. The rise was due to the initiation of the firm’s Phase III clinical programme for broad-spectrum antifungal treatment isavuconazole, as well as from expenses related to the manufacturing of alitretinoin, a synthetic retinoid drug for patients with severe dermatitis of the hand who do not respond to topical corticosteroid treatment. Basilea hopes to get market approval for the latter before the end of the year.
General and administrative expenses reached 10.8 million francs in the first six months of 2007, which Basilea said reflected initial set-up costs for an international sales and marketing organisation. Revenues for the period were down 12.9% to 3.4 million francs.