Forest Laboratories and AstraZeneca to Co-Develop and Commercialize a Late Stage Next Generation Anti-Infective
August 12 2009 - 4:00AM
Business Wire
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
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.
Except for the historical information contained herein, this
release contains forward-looking statements within the meaning of
the Private Securities Litigation Reform Act of 1995. These
statements involve a number of risks and uncertainties, including
the difficulty of predicting FDA approvals, the acceptance and
demand for new pharmaceutical products, the impact of competitive
products and pricing, the timely development and launch of new
products, and the risk factors listed from time to time in Forest
Laboratories' Annual Report on Form 10-K, Quarterly Report on Form
10-Q, and any subsequent SEC filings.
Merrem is a trademark of the AstraZeneca group of companies.
CytoFab is a trademark of Protherics Inc., a BTG plc group
company.
Forest Road Acquisition (NYSE:FRX)
Historical Stock Chart
From May 2024 to Jun 2024
Forest Road Acquisition (NYSE:FRX)
Historical Stock Chart
From Jun 2023 to Jun 2024