Swiss drugmaker Basilea Pharmaceutica reported a double dose of positive pipeline news today, announcing that it has started a second Phase III trial of antibiotic ceftobiprole and completed patient recruitment into a pivotal trial of dermatitis drug alitretinoin.
Ceftobiprole, partnerd with Johnson & Johnson, is already in a pivotal trial involving patients with skin and soft tissue infections and will now also be studied in community-acquired pneumonia, which affects upwards of five million people worldwide every year.
The antibiotic is the first in a new class of broad-spectrum cephalosporins with activity against problem pathogens, including methicillin-resistant Staphylococcus aureus, according to Basilea. J&J secured rights to the antibiotic in February 2005 in a deal that could bring in 370 million Swiss francs to Basilea in upfront and milestone payments.
Ceftobiprole is one of several new drugs that have been developed to combat emerging resistant organisms in recent years, after a prolonged period where research into new antibiotics was on the wane. Others include Pfizer’s Zeven (dalbavancin) and Zyvox (linezolid), Cubist Pharmaceuticals’ Cubicin (daptomycin), Theravance’s televancin and Wyeth’s Tygacil (tigecycline).
Meanwhile, Basilea said it had enrolled 1,000 patients into its BACH study of oral alitretinoin, a synthetic retinoid drug, for patients with severe dermatitis of the hand who do not respond to topical corticosteroid treatment.
Patients who do not respond to topical therapy currently have limited treatment options, said Basilea, and in severe cases the illness can result in significant disability. The company estimates approximately 1 million patients in leading markets suffer from severe chronic hand dermatitis and do not respond to topical treatments.
