AstraZeneca anticipates filing for approval in Europe by the end of 2010.
AstraZeneca and Forest Laboratories agreed to co-develop and commercialize the latter’s Phase III broad-spectrum antibiotics in all markets outside the U.S., Canada, and Japan. The drug called ceftaroline is in development for the treatment of complicated skin and skin structure infections (cSSSI) and community-acquired bacterial pneumonia (CABP).
AstraZeneca will take on all development, regulatory, and commercialization activities in its licensed territories and pay Forest a signing fee, sales-related royalties, and sales-related milestones. Forest anticipates filing an NDA for ceftaroline in the U.S. by the end of 2009, with AstraZeneca aiming to submit an MAA to European regulatory authorities by the end of 2010.
Forest has already conducted four pivotal Phase III trials with ceftaroline. The company claims the results show the new drug demonstrates activity against gram-positive pathogens including MRSA and MDRSP as well as against common gram-negative pathogens. In vitro studies have also shown ceftaroline to have antibacterial activity against vancomycin-resistant S. aureus and linezolid-resistant S. aureus.
Forest acquired worldwide rights to ceftaroline, excluding Japan, through its acquisition of Cerexa in 2007. Japanese rights to the drug are held by Takeda Pharmaceutical.