Wednesday, 12 August 2009
AstraZeneca and Forest Laboratories announced today they have entered into a definitive collaboration agreement to co-develop and commercialise 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 MerremTM, and our significant investment in antibiotic research, as well as agents in development such as CytoFabTM. 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.
NOTES TO EDITORS:
About Ceftaroline
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.
About AstraZeneca
AstraZeneca is a major international healthcare business engaged in the
research, development, manufacturing and marketing of meaningful
prescription medicines and supplier for healthcare services. AstraZeneca
is one of the world's leading pharmaceutical companies with healthcare
sales of US$ 31.6 billion and is a leader in gastrointestinal,
cardiovascular, neuroscience, respiratory, oncology and infectious
disease medicines. For more information about AstraZeneca, please visit:
www.astrazeneca.com
About Forest Laboratories
Forest Laboratories (NYSE: FRX) is a U.S.-based pharmaceutical company
with a long track record of building partnerships and developing and
marketing products that make a positive difference in people's lives. In
addition to its well-established franchises in therapeutic areas of the
central nervous and cardiovascular systems, Forest's current pipeline
includes product candidates in all stages of development and across a
wide range of therapeutic areas. The company is headquartered in New
York, NY. To learn more about Forest Laboratories, visit www.FRX.com.
Merrem is a trademark of the AstraZeneca group of companies.
CytoFab is a trademark of Protherics Inc., a BTG plc group company.
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