OSI Pharmaceuticals and AVEO Pharmaceuticals Expand Oncology Discovery and Translational Research Collaboration
July 21 2009 - 7:30AM
Business Wire
OSI Pharmaceuticals, Inc. (NASDAQ:OSIP) and AVEO
Pharmaceuticals, Inc. today announced that they have expanded the
drug discovery and translational research collaboration announced
in October of 2007. The alliance is anchored around developing
molecular targeted therapies to target the underlying mechanisms of
epithelial-mesenchymal transition (EMT) in cancer and to develop
proprietary datasets of associated patient selection biomarkers to
support OSI’s targeted medicine pipeline. EMT is a process of
emerging significance in tumor development and disease progression
and the focal point of OSI’s proprietary oncology research efforts.
The companies are expanding their efforts to validate cancer
targets and to deploy key elements of AVEO’s proprietary
translational research platform in support of OSI’s clinical
development programs.
Under the terms of the expanded discovery and research
agreement, OSI will pay AVEO a total of $20 million at closing, $5
million of which is an upfront cash payment and $15 million of
which is the purchase of additional equity in AVEO. OSI will also
provide AVEO research funding over the next two years to support
the collaboration, and the potential to achieve additional
royalties and milestones. In return, OSI will immediately receive
rights beyond the original collaboration including rights to
additional EMT targets (including up to 4 antibody targets) and
increased access to AVEO technology (i.e. tumor models, archives
and biomarkers). OSI is also acquiring non-exclusive access to
AVEO’s proprietary bioinformatics platform. In addition, OSI will
have the option to internalize key elements of AVEO’s proprietary
technology platform including the Human Response Platform (HRP™)
for the identification of novel EMT agents and proprietary patient
selection biomarkers in support of OSI’s clinical development
programs.
“Our initial collaboration with AVEO has convinced us that these
platforms represent a valuable and integral component in our
ongoing efforts to maintain our leadership position in exploiting
the biology of EMT,” stated Colin Goddard, Ph.D., Chief Executive
Officer of OSI Pharmaceuticals. “Expanding the collaboration fits
squarely within our strategic plan to deliver a differentiated and
powerful approach to the discovery, development and
commercialization of novel new medicines for the treatment of
cancer.”
“We are very pleased to expand our collaboration with OSI
Pharmaceuticals, a clear leader in the development of
oncotherapeutics,” stated Tuan Ha-Ngoc, president and chief
executive officer of AVEO Pharmaceuticals. “This agreement
demonstrates the unique insights and value AVEO’s novel cancer
biology platform brings to cancer drug development. Furthermore,
our partnerships, including this expanded alliance, have enabled
AVEO to build a sustainable company and underscore our ability to
raise funds without diluting the value of our later-stage
assets.”
About EMT Research at OSI
Epithelial-to-Mesenchymal Transition (EMT), and its reverse
Mesenchymal-to-Epithelial transition (MET) are important phenomena
in developmental biology that are increasingly associated with
tumor biology. EMT is thought to be a marker of tumor
progression, with tumors that express mesenchymal markers having a
greater tendency to be invasive and metastasize than those tumors
only expressing epithelial markers. OSI’s interest in EMT
derived from its translational research efforts into better
understanding which patients optimally benefit from therapy with
the company’s flagship product, Tarceva® (erlotinib). Because
mesenchymal tumor cells co-opt different sets of oncogenic
signaling pathways, EMT targets represent a novel therapeutic
opportunity in an area of significant unmet medical need. OSI
has surmised that understanding and targeting the dynamic
biological processes of EMT has offered it the opportunity to
establish a highly differentiated, industry leading position as the
organization best able to capitalize on this emerging field of
oncology research. The company has focused its oncology research on
discovering and validating EMT related targets; developing novel
therapies – and combinations of therapies – against these EMT
targets; developing specialized animal models that recapitulate EMT
processes; and identifying and validating biomarkers to support
these programs. The company believes that developing a
differentiated and industry leading technology platform for its
oncology research efforts is an essential component in establishing
the strategic value of OSI’s oncology franchise.
About AVEO’s Human Response Platform (HRP™)
For decades, the standard preclinical model for testing the
efficacy of novel oncology drug candidates has been the human tumor
xenograft model. However, well-known challenges with these models
include the artificial nature of the implanted tumor cells, which
have adapted for growth in culture as opposed to an in vivo
environment that would most closely mimic tumor activity in humans.
Despite the low success rate of oncology products in clinical
development – in part due to the high rate of false positives
associated with this method of testing – xenografts are used
broadly throughout the industry because no better model system has
been available to more accurately predict success in the
clinic.
AVEO’s HRP is designed to meet and overcome these challenges.
HRP is based on the company’s proprietary, genetically-defined
mouse models of human cancer, in which each model is engineered to
contain signature genetic mutations that are present in human
disease. Beyond these cancer-initiating engineered mutations, the
resultant tumors acquire common and distinct spontaneous mutations
during tumor progression. These mutations provide additional
natural genetic variation more akin to the range of genetic
heterogeneity encountered across different primary human tumors.
The tumor-to-tumor genetic variation in the system provides the
opportunity to identify genetic correlations between responding and
non-responding tumor populations, and to apply such genetic
profiles in clinical development.
About OSI Pharmaceuticals
OSI Pharmaceuticals is committed to "shaping medicine and
changing lives" by discovering, developing and commercializing
high-quality, novel and differentiated targeted medicines designed
to extend life and improve the quality of life for patients with
cancer and diabetes/obesity. For additional information about OSI,
please visit http://www.osip.com.
About AVEO
AVEO is a late-stage biopharmaceutical company focused on the
discovery and development of novel, targeted cancer therapeutics.
AVEO’s proprietary, integrated cancer biology platform enables the
company to pursue highly efficient drug development strategies in
oncology that increase the probability of clinical success and
provides a discovery engine for high-value targets and therapies.
This approach has resulted in a balanced pipeline of novel cancer
therapies focused on well-validated targets (VEGFR, EGFR) and
promising novel targets (HGF, FGFR, ErbB3 and NOTCH), as well as
collaborations with Eli Lilly, Merck, OSI Pharmaceuticals,
Schering-Plough and Biogen Idec. The company’s lead product,
tivozanib (AV-951), a triple VEGF receptor inhibitor, recently
completed Phase 2 clinical development in patients with metastatic
renal cell cancer and is expected to enter Phase 3 development in
2009. Through a combination of internal drug discovery and
selective in-licensing of targeted therapeutics, AVEO is building a
diversified product pipeline and moving toward its vision of
becoming a fully integrated biopharmaceutical company. For more
information, please visit the company's website at
www.aveopharma.com.
This news release contains forward-looking statements of
OSI. These statements are subject to known and unknown risks and
uncertainties that may cause actual future experience and results
to differ materially from the statements made. Factors that might
cause such a difference include, among others, OSI's and its
collaborators' abilities to effectively market and sell Tarceva and
to expand the approved indications for Tarceva, OSI's ability to
protect its intellectual property rights, safety concerns regarding
Tarceva, competition to Tarceva and OSI's drug candidates from
other biotechnology and pharmaceutical companies, the completion of
clinical trials, the effects of FDA and other governmental
regulation, including pricing controls, OSI's ability to
successfully develop and commercialize drug candidates, and other
factors described in OSI Pharmaceuticals' filings with the
Securities and Exchange Commission.
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