NEW YORK & LONDON--(BUSINESS WIRE)--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 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.
Source: Forest Laboratories
AstraZeneca
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