Array BioPharma Receives Phase 2 Milestone Payment From AstraZeneca
BOULDER, Colo., Sept. 14 /PRNewswire-FirstCall/ -- Array BioPharma Inc.
(Nasdaq: ARRY) today announced that it received a $3 million payment from
AstraZeneca (NYSE: AZN) for achieving a Phase 2 milestone for AZD6244
(ARRY-142886). The payment was triggered upon dosing the first patient in a
Phase 2 trial. AZD6244 (ARRY-142886) is a selective MEK inhibitor that was
in-licensed by AstraZeneca from Array in December 2003.
The previously announced Phase 2 randomized study will compare AZD6244
(ARRY-142886) to temozolomide in the treatment of stage III / IV melanoma
patients. AstraZeneca expects to enroll up to 180 patients at approximately
40 centers worldwide. Additional Phase 2 studies, in a range of other
tumors, are scheduled to start this year.
Initiation of the Phase 2 study is based on the results of the Phase 1b
study which recently completed recruitment, and which included patients
with melanoma and a variety of other solid tumors. The Phase 1 study
clearly demonstrated that AZD6244 (ARRY-142886) inhibits MEK and associated
downstream markers in tumors at doses deemed well tolerated. The full
results of this study will be published later in the year.
Array was responsible for filing the IND and conducting the Phase 1
clinical testing of AZD6244 (ARRY-142886). AstraZeneca is responsible for
all other aspects of clinical development and commercialization.
About the Collaboration:
AstraZeneca acquired exclusive worldwide rights to AZD6244 and certain
second-generation compounds for all oncology indications in December 2003.
Array retains the rights to all therapeutic indications outside of oncology
for compounds not selected by AstraZeneca as part of the collaboration.
About AZD6244 (ARRY-142886)
AZD6244 (ARRY-142886) is a potent, selective MEK inhibitor that is
orally active, that blocks signal transduction pathways implicated in
cancer cell proliferation and survival. AZD6244 (ARRY-142886) has shown
tumour suppressive activity in multiple pre-clinical models of human cancer
including melanoma, pancreatic, colon, lung, and breast cancers.
About MEK Inhibition
MEK is a critical enzyme at the intersection of several biological
pathways, which regulates cell proliferation and survival as part of the
Ras/Raf/MEK/ERK pathway. Activation of the Ras/Raf/MEK/ERK pathway has been
implicated in many cancers, including lung, pancreatic, colon, melanoma and
thyroid cancer. MEK inhibition is an attractive anti-cancer strategy as it
has the potential to block inappropriate signal transduction regardless of
the upstream position of the oncogenic aberration.
About Melanoma
More than 80,000 people are diagnosed with malignant melanoma each
year, approximately 20% of them with advanced disease. Current treatments
for advanced melanoma offer little survival benefit and are associated with
considerable toxicities for the majority of patients. The outlook for
patients with metastatic disease is poor with median survival time of
between 6-12 months and a 5-year survival rate of approximately 10%. There
is a great need for new and effective treatments for advanced melanoma that
can extend the life of patients and improve their quality of life while
receiving treatment by reducing the burden of toxicities associated with
today's treatments.
About AstraZeneca
AstraZeneca is a major international healthcare business engaged in the
research, development, manufacture and marketing of prescription
pharmaceuticals and the supply of healthcare services. It is one of the
world's leading pharmaceutical companies with healthcare sales of $23.95
billion and leading positions in sales of gastrointestinal, cardiovascular,
neuroscience, respiratory, oncology and infection products. AstraZeneca is
listed in the Dow Jones Sustainability Index (Global) as well as the
FTSE4Good Index. For further information please visit
www.astrazenecapressoffice.com.
About Array BioPharma
Array BioPharma is a biopharmaceutical company focused on the
discovery, development and commercialization of orally active drugs to
address significant unmet medical needs. Our proprietary drug development
pipeline is primarily focused on the treatment of cancer and inflammatory
disease and includes several small molecule drug candidates that are
designed to regulate targets in therapeutically important biologic
pathways. We currently have three drugs in clinical development including
our MEK inhibitor for cancer, AZD6244 (ARRY-142886), which is in Phase 2
with AstraZeneca, and two Array wholly-owned drugs in Phase 1: ARRY-543,
our ErbB-2 / EGFR inhibitor for cancer, and ARRY-162, our MEK inhibitor for
inflammatory disease. For more information on Array, please go to
www.arraybiopharma.com.
Array BioPharma's Forward-Looking Statement
This press release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995 that
involve significant risks and uncertainties, including those discussed in
our annual report filed on form 10-K for the year ended June 30, 2006, and
in other reports filed by Array with the Securities and Exchange
Commission. Because these statements reflect our current expectations
concerning future events, our actual results could differ materially from
those anticipated in these forward-looking statements as a result of many
factors. These factors include, but are not limited to, our ability to
continue to fund and successfully progress internal research efforts and to
create effective, commercially viable drugs, our ability to achieve and
maintain profitability, the extent to which the pharmaceutical and
biotechnology industries are willing to in-license drug candidates for
their product pipelines and to collaborate with and fund third parties on
their drug discovery activities, our ability to out-license our proprietary
candidates on favorable terms, risks associated with our dependence on our
collaborators for the clinical development and commercialization of our
out-licensed drug candidates, the ability of our collaborators and of Array
to meet objectives tied to milestones and royalties, and our ability to
attract and retain experienced scientists and management. We are providing
this information as of September 14, 2006. We undertake no duty to update
any forward-looking statements to reflect the occurrence of events or
circumstances after the date of such statements or of anticipated or
unanticipated events that alter any assumptions underlying such statements.
SOURCE Array BioPharma Inc.
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