Array BioPharma Inc.,(NASDAQ: ARRY), Boulder, Colo., has reported
financial results for the third quarter of fiscal 2007. Array reported
revenue of $10.4 million for the third quarter of fiscal 2007, compared
to revenue of $11.7 million for the same period in fiscal 2006.
Collaboration revenue decreased as a result of shifting resources to
advance and expand Array's internal proprietary drug discovery
programs. Revenue from license fees and milestone payments increased due
to achieving milestones that trigger payments from AstraZeneca PLC and
InterMune, Inc. Array invested $15.7 million in proprietary research and
development for the quarter in connection with advancing its eight
wholly owned development programs as well as its portfolio of discovery
programs.
This compares to $7.7 million during the same quarter last year.
Array reported a net loss of $14.1 million, or ($0.35) per share, for
the third quarter, compared to a net loss of $9.2 million, or ($0.24)
per share, for the same quarter in fiscal 2006. Array ended the third
quarter of fiscal 2007 with $73.9 million in cash, cash equivalents and
marketable securities. "Array has a deep development pipeline which
now includes five oncology programs and three programs for treating
inflammatory disease," said Robert E. Conway, CEO, Array BioPharma.
"During the remainder of calendar 2007, we anticipate having
catalysts on six wholly-owned Array drugs, including advancing two drugs
into Phase 2 clinical trials and filing two more INDs."
Third Quarter and Subsequent Accomplishments:
Advancing Proprietary Research Programs
ARRY-886 (AZD6244), a novel MEK inhibitor, is being developed by
AstraZeneca and is in Phase 2 clinical assessment in metastatic
melanoma, colorectal, pancreatic and non-small cell lung cancers.
ARRY-704 (AZD8330), a novel MEK inhibitor, entered a Phase 1 clinical
trial initiated by AstraZeneca in cancer patients, triggering a $2
million milestone payment to Array. Array's co-development and
commercialization partnership with AstraZeneca for the oncology portion
of its MEK portfolio, including its lead compound, ARRY-886, included
research and development of additional clinical candidates, which
resulted in the selection of ARRY-704 in December 2005.
Advanced ARRY-543, an oral, selective, reversible, small molecule
tyrosine kinase inhibitor of both ErbB-2 and EGFR for cancer, in a Phase
1 clinical trial. Array reported positive Phase 1 interim results in
December 2006: the compound demonstrated consistent drug exposure and
four patients had stable disease at doses that were well tolerated.
Continued a Phase 1 clinical trial in healthy volunteers for
Array's first-in-class MEK inhibitor for inflammatory disease,
ARRY-162. There have been no serious adverse events through 14 days of
continuous dosing and cytokine production was significantly inhibited
after ex-vivo stimulation of clinical samples. Results of this trial
will be presented at the European League Against Rheumatism (EULAR)
Congress in June 2007.
Continued a Phase 1b combination trial with ARRY-162 and
methotrexate in stable rheumatoid arthritis patients, which will
evaluate safety, tolerability, pharmacokinetics, biomarkers and initial
signs of efficacy.
Completed a Phase 1a single ascending dose escalation study in
healthy volunteers for ARRY-797, a selective, orally active p38
inhibitor for inflammation, which evaluated safety, exposure and
inhibition of mechanism-related biomarkers. Results of this trial will
be presented at the European League Against Rheumatism (EULAR) Congress
in June 2007. Filed an Investigational New Drug (IND) application for
ARRY-797 with the U.S. Food & Drug Administration (FDA) and is now
able to proceed with a Phase 1 clinical trial in cancer patients.
ARRY-797 has shown good efficacy and a low side effect profile in
preclinical models of certain cytokine-driven cancers.
Initiated enrollment of cancer patients to participate in a Phase 1
clinical trial for ARRY-520, a small molecule Kinesin Spindle Protein
(KSP) inhibitor. In vivo, ARRY-520 caused marked tumor regression in
preclinical models of human solid tumors and human leukemias, often
leading to durable responses.
Finishing regulated safety assessment testing for ARRY-380, an
oral, selective ErbB-2 inhibitor for cancer, and preparing an IND
application to submit to the FDA.
Identified and advanced into regulated safety assessment testing a
new compound, ARRY-614, a p38 / Tie-2 inhibitor for inflammation and
cancer. This mechanism simultaneously targets both cytokine
growth-driven and angiogenesis-driven mechanisms in cancer. The compound
has shown to block angiogenesis, inhibit inflammation and antagonize
tumor growth, while also demonstrating a low side effect profile in
preclinical models of human cancer and arthritis.
Partnered Research
Entered into a license agreement with VentiRx Pharmaceuticals Inc.,
a privately held biopharmaceutical company, granting VentiRx exclusive
worldwide rights to Array's Toll-like receptor (TLR) program. The
program contains a number of development candidates targeting TLRs to
activate innate immunity. VentiRx expects to develop its first two
candidates in oncology and allergy. Financial terms of the agreement
were not disclosed, but Array received an equity stake in VentiRx as
well as an upfront payment, and will receive potential milestone
payments and royalties on product sales. Array retains the option to
acquire a 50% ownership position in all VentiRx clinical oncology
products developed under this agreement. Received a $500,000 milestone
payment from InterMune, Inc. for ITMN-191, an oral hepatitis C virus
protease inhibitor, being dosed in patients in a Phase 1a clinical
trial.
Enhancing Leadership
Appointed Neil Spector, M.D., to Array's Scientific Advisory
Board. Dr. Spector will help Array in the development of its cancer
portfolio. Dr. Spector, with 20 years of oncology experience, recently
joined Duke University Medical Center's cancer drug development
team as the new Director of Translational Research in Oncology. He also
serves as Co-Director of the Experimental Therapeutics Program in the
cancer center. Prior to joining Duke, Dr. Spector served as Director of
GlaxoSmithKline's Exploratory Medical Sciences in Oncology, where
he successfully developed two important cancer drugs, Tykerb (lapatinib)
and Nelarabine (ara-G analog), from the bench to the clinic and then
guided them through FDA approval.
Array reported revenue of $29.0 million for the nine-month period
ended March 31, 2007, compared to revenue of $34.9 million for the same
period in fiscal 2006. Net loss for the nine months ended March 31,
2007, was $38.2 million, or ($0.97) per share, compared to a net loss of
$27.6 million, or ($0.71) per share, reported in the same period in
fiscal 2006.
About Array BioPharma
Array BioPharma Inc. is a biopharmaceutical company focused on the
discovery, development and commercialization of targeted small molecule
drugs to treat life threatening and debilitating diseases. Our
proprietary drug development pipeline is focused on the treatment of
cancer and inflammatory disease and includes clinical candidates that
are designed to regulate therapeutically important targets. In addition,
leading pharmaceutical and biotechnology companies collaborate with
Array to discover and develop drug candidates across a broad range of
therapeutic areas.
For more information, vist http://www.arraybiopharma.com or
303/386-1193.
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