Forest Laboratories and AstraZeneca announced they have entered into a definitive collaboration agreement to co-develop and commercialize ceftaroline in all markets outside the United States, Canada and Japan.
Ceftaroline is Forest’s late stage, next generation cephalosporin being investigated for the treatment of complicated skin and skin structure infections (cSSSI) and community-acquired bacterial pneumonia (CABP). Ceftaroline demonstrates bactericidal activity against a broad range of pathogens commonly implicated in cSSSI and CABP, including methicillin-resistant Staphylococcus aureus (MRSA) and multi-drug resistant Streptococcus pneumoniae (MDRSP).
Under the terms of the agreement AstraZeneca will pay Forest an undisclosed signing fee, sales-related royalties and payments for reaching certain sales milestones. AstraZeneca will assume responsibility for the development, regulatory approval and commercialization of ceftaroline in the licensed territory. The parties will collaborate on future development activities. Further financial terms were not disclosed.
Forest expects to file a New Drug Application in the U.S. by the end of 2009 with AstraZeneca filing a Marketing Authorization Application in Europe by the end of 2010.
The strong demand for new anti-infectives is being driven by the ever-increasing development of bacterial resistance to marketed antibiotics. Currently, many bacterial infections have few satisfactory treatment options and rates of pneumonia and skin infections being caused by MRSA are increasing.
Forest has conducted four pivotal, Phase III trials with ceftaroline to assess its efficacy and safety profile in treating cSSSI and CABP. The trials showed that versus currently marketed comparators, ceftaroline exhibited activity against gram-positive pathogens (including MRSA and MDRSP) and common gram-negative pathogens and was generally well tolerated. If approved, ceftaroline could be used as a first-line treatment for both CABP and cSSSI.