Forest Labs and Astrazeneca to co-develop and commercialize ceftaroline

Aug 12 2009

Forest Laboratories (NYSE:FRX) and AstraZeneca (NYSE:AZN) announced today 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.

David Brennan, AstraZeneca Chief Executive Officer said: “AstraZeneca and Forest Laboratories, through a successful partnership, aim to battle the growing problem of antibiotic resistance. This collaboration complements our existing antibiotic Merrem^TM, and our significant investment in antibiotic research, as well as agents in development such as CytoFab^TM. We are excited to be partnering with Forest and to be part of ceftaroline’s future.”

Howard Solomon, Chairman and Chief Executive Officer of Forest Laboratories said: “We are pleased to enter this partnership with AstraZeneca for the development and commercialization of ceftaroline outside North America. We believe AstraZeneca’s expertise in the anti-infective field together with their first-class global sales and marketing organization will help bring this important therapeutic, if approved, to patients with severe skin and respiratory infections worldwide. We expect this partnership, along with our more recent product launches, will produce economic benefit during periods when we face patent expirations.”

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.

Ceftaroline is a novel, bactericidal, injectable, broad-spectrum cephalosporin being developed as a therapeutic agent for the treatment of cSSSI and CABP which include gram-positive pathogens such as methicillin-resistant Staphylococcus aureus (MRSA) and multidrug-resistant S. pneumoniae (MDRSP), as well as common gram-negative organisms. Ceftaroline has demonstrated antibacterial activity in-vitro against vancomycin-resistant S. aureus (VRSA) and linezolid-resistant S. aureus. Ceftaroline is a member of the cephalosporin class of antibiotics, the most frequently prescribed class of antibiotics in the world. In clinical trials, ceftaroline has been generally well tolerated with a safety profile consistent with the cephalosporin class of antibiotics. Forest obtained the worldwide rights (excluding Japan, where Takeda Pharmaceuticals holds rights) to ceftaroline when it acquired Cerexa, Inc., a privately held biopharmaceutical company, in 2007.

www.FRX.com and www.astrazeneca.com