Basilea is developing and marketing drugs for the treatment of bacterial and fungal infections as well as marketing Toctino for severe forms of hand eczema. Toctino, the company’s first approved drug, was launched in fall 2008 in the EU for the treatment of severe hand eczema. The US Phase III study is ongoing and expected to report clinical results by late 2011. Ceftobiprole, a novel cephalosporin active against methicillin-resistant staph aureus (MRSA), failed to gain US FDA approval in December 2009. Basilea and Johnson & Johnson initiated an arbitration panel that in November 2010 decided that Johnson & Johnson violated a license agreement between the two companies resulting in regulators rejecting the drug for the treatment of severe skin infections. Basilea received a USD 130 mn award including lost milestone payments, damages, and interest.
The company’s antifungal drug Isavuconazole suffered a significant development time delay due to manufacturing and quality issues, pushing initial Phase III results for the treatment of candida infections out to 2013. With the recent co-development deal with Astellas, most of the development costs for Isavuconazole are paid for by Astellas.