BOULDER, Colo., Jan. 23, 2015 /PRNewswire/ -- Array
BioPharma Inc. (NASDAQ: ARRY) today announced that it has reached a
definitive agreement with Novartis Pharma AG to acquire worldwide
rights to encorafenib (LGX818), a BRAF inhibitor currently in Phase
3 development. This agreement is conditional on the
closing of transactions announced by Novartis and GlaxoSmithKline
PLC (GSK) on April 22, 2014, which are expected to close in
the first half of 2015, and the agreement remains subject to the
receipt of regulatory approvals. Array previously announced a
definitive agreement with Novartis to regain global rights to the
Phase 3 MEK inhibitor binimetinib, the material terms of which
remain in place following this agreement. In order to address
competition concerns raised by the European Commission, Array has
agreed to obtain an experienced partner for global development and
European commercialization of both binimetinib and encorafenib. The
European Commission is expected to issue a decision regarding the
Novartis-GSK transaction on January 28,
2015.
"Acquiring worldwide rights to encorafenib, an innovative
late-stage oncology product, represents a tremendous opportunity
for Array," said Ron Squarer, Chief Executive Officer, Array
BioPharma. "There are currently eleven active encorafenib
clinical trials, including the Phase 3 COLUMBUS trial in which
encorafenib is being studied in combination with binimetinib for
BRAF+ melanoma patients. With rights to both encorafenib and
binimetinib, Array would enhance its position to broadly develop
and commercialize each product, as well as this MEK/BRAF
combination, which may have differentiating advantages when
compared to available therapies."
Terms of the Agreement
Upon satisfaction of all conditions and closing of the deal,
Array will acquire global rights to encorafenib. Other than a
de minimis payment due to Novartis from Array, there are no
milestone payments or royalties payable under this agreement by
either party. Novartis has agreed to provide transitional
regulatory, clinical development and manufacturing services as
specified below and will assign or license to Array all patent and
other intellectual property rights Novartis owns to the extent
relating to encorafenib. As part of the transaction, Array
has agreed to obtain an experienced partner for global development
and European commercialization of both binimetinib and
encorafenib. If Array is unable to find a suitable partner in
the prescribed time period, a trustee would have the right to sell
such European rights.
Novartis will conduct and fund the COLUMBUS trial through the
earlier of June 30, 2016 or
completion of last patient first visit. At that time, Array
will assume responsibility for the trial, while Novartis will
reimburse Array for out-of-pocket costs along with 50% of Array's
full time equivalent (FTE) costs in connection with completing the
COLUMBUS trial. Novartis is responsible for conducting all other
encorafenib trials until their completion or transfer to Array for
a defined transition period. For all trials transferred to
Array, Novartis will reimburse Array for out-of-pocket costs and
50% of Array's FTE costs in connection with completing the
trials.
Novartis will supply encorafenib for clinical and commercial use
for up to 30 months after closing and will also assist Array in the
technology and manufacturing transfer of encorafenib.
Novartis will also provide Array continued access to several
Novartis pipeline compounds for use in currently ongoing
combination studies, and possible future studies, including Phase 3
trials, with encorafenib. The effectiveness of the agreement is
subject to the receipt of regulatory approvals and to the
consummation of the Novartis-GSK transaction.
In addition, Array agreed to undertake to obtain certain third
party consents or waivers necessary for Array to consummate the
transactions under the Novartis Agreement.
Conference Call Information
Array will hold a conference call on January 23,
2015 at 9:00 a.m. Eastern Time to discuss this
announcement. Ron Squarer, Chief Executive Officer, will lead
the call.
Date:
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January 23,
2015
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Time:
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9:00 a.m. Eastern
Time
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Toll-Free:
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(844)
464-3927
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Toll:
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(765)
507-2598
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Pass
Code:
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71572963
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Webcast, including Replay and Conference Call Slides:
http://edge.media-server.com/m/p/ykxqbcwi/lan/en
About BRAF and Encorafenib
Raf is a key protein kinase in the RAS/RAF/MEK/ERK signaling
pathway, which regulates several key cellular activities including
proliferation, differentiation, migration, survival and
angiogenesis. Inappropriate activation of this pathway
through BRAF mutations has been shown to occur in many cancers,
such as melanoma, colorectal and thyroid cancers. Encorafenib is a
potent and highly selective small molecule BRAF inhibitor that
targets a key enzyme in this pathway and has shown clinical
activity in a Phase 1 study in advanced tumors including melanoma
and metastatic colorectal cancer. A Phase 3 trial with
encorafenib in combination with binimetinib in BRAF+ melanoma
(COLUMBUS) is actively enrolling patients. In addition,
encorafenib is being studied in ten other clinical trials,
including BRAF+ colorectal cancer.
BRAF Colorectal Cancer
At the 2014 EORTC-NIC-AACR Symposium on Molecular Targets and
Cancer Therapeutics, preliminary results of a Phase 1 study were
presented that showed a combination of encorafenib, cetuximab, an
EGFR inhibitor, and alpelisib, a PI3K pathway inhibitor, may be an
effective treatment for patients with BRAF+ colorectal
cancer. For the Phase 1 study, which continues to enroll
participants, patients with BRAF+ colorectal cancer were randomly
assigned to receive encorafenib plus cetuximab with or without
alpelisib. Results showed that the two-drug combination
produced an objective response rate of 23%, while nearly one third
(32%) of patients treated with the three-drug combination achieved
an objective response. In addition, the median progression-free
survival was 3.7 months and 4.3 months for the two-drug and
three-drug combination groups, respectively. The researchers
noted that the median progression-free survival times observed in
this study are nearly double those for patients who have been
treated with standard therapy in the past. Furthermore, the
combination of drugs was generally well-tolerated among
patients. There are over 200,000 colorectal cancer patients
in the U.S. and it is estimated that the BRAF mutation is found in
approximately 12% of this population.
BRAF Melanoma
Interim results from a Phase 1b study with binimetinib and
encorafenib were presented by Novartis at the 2013 International
Myeloma Conference. The study demonstrated a disease control
rate (>stable disease) of 100%, and an overall response rate
(>partial response) of 89%, including one complete response, in
BRAF inhibitor naive melanoma patients. In melanoma patients
who had been previously treated with a BRAF inhibitor, the disease
control rate was 64%.
Preliminary data from the Phase 1b study also indicate that
binimetinib and encorafenib may be safely combined at the intended
single-agent doses. Unlike other BRAF inhibitor / MEK
inhibitor combinations, in this study there were no febrile (fever)
or photosensitivity events, and a low incidence of rash was
reported to date. There were no signs of increased toxicity
with the combination versus single agent therapy, and the
combination showed early signs that it may mitigate some of the
on-target adverse events common with single-agent BRAF inhibitor
therapy, including cutaneous toxicities, myalgia and
arthralgia.
About MEK and Binimetinib
MEK is a key protein kinase in the RAS/RAF/MEK/ERK pathway,
which regulates several key cellular activities including
proliferation, differentiation, migration, survival and
angiogenesis. Inappropriate activation of this pathway has been
shown to occur in many cancers, in particular through mutations in
BRAF, KRAS and NRAS. Binimetinib is a small molecule MEK
inhibitor that targets a key enzyme in this pathway. Three
Phase 3 trials with binimetinib in advanced cancer patients
continue to enroll: NRAS-mutant melanoma (NEMO), low-grade serous
ovarian cancer (MILO) and BRAF-mutant melanoma (COLUMBUS).
NRAS-mutant melanoma represents the first potential indication for
binimetinib, with a projected regulatory filing estimated in the
first half of 2016.
About Array BioPharma
Array BioPharma Inc. is a biopharmaceutical company focused on
the discovery, development and commercialization of targeted small
molecule drugs to treat patients afflicted with cancer. Six
Phase 3 studies on Array invented drugs, binimetinib (partnered
with Novartis) and selumetinib (partnered with AstraZeneca), are
currently enrolling patients with cancer. For more information on
Array, please go to www.arraybiopharma.com.
Forward-Looking Statement
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995, including statements about the closing of the transaction
with Novartis, the timing of the completion or initiation of
further development of encorafenib or binimetinib, expectations
that the return of rights to encorafenib or binimetinib to Array
and other events will occur that will result in greater value for
Array, the receipt of regulatory approvals and the ability of Array
to locate a suitable development and commercialization partner for
encorafenib or binimetinib in Europe, the potential for the results of
ongoing preclinical and clinical trials to support regulatory
approval or the marketing success of encorafenib or binimetinib,
future plans to progress and develop encorafenib or binimetinib,
and our plans to build a commercial-stage biopharmaceutical
company. These statements involve significant risks and
uncertainties, including those discussed in our most recent annual
report filed on Form 10-K, in our quarterly reports filed on Form
10-Q, 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 our proprietary drugs; our ability to
effectively and timely conduct clinical trials in light of
increasing costs and difficulties in locating appropriate trial
sites and in enrolling patients who meet the criteria for certain
clinical trials; risks associated with our dependence on
third-party service providers to successfully conduct clinical
trials within and outside the United
States; our ability to achieve and maintain profitability
and maintain sufficient cash resources; and our ability to attract
and retain experienced scientists and management. We are providing
this information as of January 23, 2015. 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.
CONTACT:
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Tricia
Haugeto
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(303)
386-1193
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thaugeto@arraybiopharma.com
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SOURCE Array BioPharma Inc.