BOULDER, Colo., Dec. 3, 2014 /PRNewswire/ -- Array BioPharma
Inc. (NASDAQ: ARRY) today announced that it has reached a
definitive agreement with Novartis International Pharmaceutical
Ltd. to regain full worldwide rights to binimetinib, a MEK
inhibitor in three Phase 3 trials. This agreement is
conditional on the closing of transactions announced by Novartis
and GlaxoSmithKline PLC (GSK) on April 22,
2014, which are expected in the first half of 2015, and
remain subject to regulatory approval. Array had previously granted
Novartis worldwide exclusive rights to develop and commercialize
binimetinib under a 2010 License Agreement, which will terminate
and be superseded by a new set of agreements between the
parties.
"Regaining full worldwide rights to binimetinib, an innovative
late-stage oncology product, represents a tremendous opportunity
for Array," said Ron Squarer, Chief Executive Officer, Array
BioPharma. "Binimetinib is currently advancing in three Phase
3 clinical trials and, we expect to file for our first regulatory
approval during the first half of 2016. With this agreement,
we are in a strong position to successfully develop and
commercialize binimetinib to the benefit of cancer patients."
Novartis stated, "Binimetinib has demonstrated promising results
for cancer patients across several different clinical trials.
We are committed to supporting a successful transition to
Array."
Terms of the Agreement
Upon deal close, Array will
receive up to $85 million and
Novartis' global, exclusive license to binimetinib will terminate
with all rights reverting to Array. Novartis has agreed to
provide transitional regulatory, clinical development and
manufacturing services as specified below and will assign to Array
patent and other intellectual property rights it owns to the extent
relating to binimetinib. All clinical trials involving
binimetinib, including the COLUMBUS, NEMO and MILO pivotal trials,
will continue to be conducted as currently contemplated.
Novartis will be responsible for continued conduct and funding
of the COLUMBUS trial. This obligation will transfer to any
future owner of LGX818 (encorafenib). Following deal close,
Novartis will reimburse Array for all remaining out-of-pocket
expenses and half of all remaining fully-burdened full time
equivalent (FTE) costs associated with MILO, which Array will
continue to conduct. For NEMO and all other ongoing and
planned clinical trials, Novartis will conduct and solely fund each
trial, until a mutually agreed-upon transition date to Array.
Following this transition, Novartis will reimburse Array for all
remaining out-of-pocket expenses and half of all remaining
fully-burdened FTE costs required to complete these studies.
Novartis will remain responsible for conducting and funding
development of the NRAS melanoma companion diagnostic until
Premarket Approval is received from the U.S. Food and Drug
Administration. Following approval, Novartis will transfer
the product and Premarket Approval to a diagnostic vendor of
Array's designation.
Novartis also retains binimetinib supply obligations for all
clinical and commercial needs for up to 30 months after closing and
will also assist Array in the technology and manufacturing transfer
of binimetinib. Novartis will also provide Array continued
access to several Novartis pipeline compounds including, but not
limited to, LEE011 (CDK 4/6 inhibitor) and BYL719 (α-PI3K
inhibitor), for use in currently ongoing combination studies, and
possible future studies, including Phase 3 trials, with
binimetinib.
Conference Call Information
Array will hold a
conference call on Thursday, December 4,
2014 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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Thursday, December 4,
2014
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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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(800)
708-4540
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Toll:
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(847)
619-6397
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Pass
Code:
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38529167
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Webcast, including
Replay and Conference Call Slides:
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http://investor.arraybiopharma.com/phoenix.zhtml?c=123810&p=irol-EventDetails&EventId=5176145
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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 binimetinib,
expectations that the return of rights to binimetinib to Array and
other events will occur that will result in greater value for
Array, the potential for the results of ongoing preclinical and
clinical trials to support regulatory approval or the marketing
success of a drug candidate, future plans to progress and develop
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 December 3,
2014. 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:
|
Tricia
Haugeto
|
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(303)
386-1193
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thaugeto@arraybiopharma.com
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SOURCE Array BioPharma