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AZ and Forest collaborate on anti-infective

Leading firms agree deal to commercialise novel antibiotic as the demand for anti-infectives rises

AstraZeneca (AZ) and Forest Laboratories have agreed a definitive collaboration deal to co-develop and commercialise the antibiotic ceftaroline in all markets outside Canada, Japan and the US.

The deal has been spurred by strong demand for new anti-infectives, driven by the increasing development of bacterial resistance to existing antibiotics. Growing numbers of bacterial infections have few satisfactory treatment options, and the incidence of pneumonia and skin infections caused by MRSA is rising.

"This collaboration complements our existing antibiotic Merrem and our significant investment in antibiotic research, as well as agents in development such as CytoFab," said AZ CEO, David Brennan.

Ceftaroline is Forest's late-stage, next-generation cephalosporin, which is being investigated for the treatment of complicated skin and skin structure infections (cSSSI) and community-acquired bacterial pneumonia (CABP).

Under the terms of the deal, AZ will pay Forest an undisclosed signing fee, sales-related royalties and payments for reaching sales milestones. AZ will be responsible for the development, regulatory approval and commercialisation of ceftaroline in the licensed territory.

Forest has carried out four pivotal, phase III trials with ceftaroline to assess its efficacy and safety profile in treating both cSSSI and CABP. Trials revealed that versus currently marketed comparators, ceftaroline showed activity against gram-positive pathogens (including MRSA and MDRSP) and common gram-negative pathogens. It was also generally well tolerated.

The US-based company expects to file a New Drug Application in the US by the end of 2009 with AZ filing a Marketing Authorisation Application in Europe by the end of 2010. If ceftaroline is approved it could be used as a first-line treatment for both cSSSI and CABP.

12th August 2009

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