BOULDER, Colo., March 2, 2015 /PRNewswire/ -- Following
announcements from both Novartis and GlaxoSmithKline regarding
close of their transactions, Array BioPharma Inc.
(NASDAQ: ARRY) today announced the completion of both the
binimetinib and encorafenib definitive agreements with
Novartis. Along with global ownership of both assets, Array
will receive an upfront payment of $85
million from Novartis.
Ron Squarer, Chief Executive Officer of Array, noted, "With
the close of the Novartis-GSK transaction, Array now owns both
binimetinib and encorafenib, two innovative oncology products in
Phase 3, with plans for regulatory submissions in 2016. These
transformative transactions have accelerated our path to
commercialization and provide us with the opportunity to develop
two potentially broadly active products in a number of
indications."
Leadership Changes
Array announced today
that Andrew Robbins, Array's Senior Vice President of
Commercial Operations, has been appointed Chief Operating Officer,
with responsibility for sales, marketing, manufacturing and
business development activities at Array. In this expanded
role, Mr. Robbins will be instrumental in ensuring successful
commercialization of binimetinib and encorafenib.
Ron Squarer noted, "Since joining Array, Mr. Robbins has
established himself as a key member of the leadership team, helping
to shape Array's strategy and execute our plans. I am
confident in his ability to lead in this broader role as we evolve
into a fully-integrated biopharmaceutical company."
Array also announced that Dr. David
Snitman, Chief Operating Officer, has announced his
intention to retire at the end of June
2015. Until that time, Dr. Snitman will serve as Executive
Vice President of Business Development.
"Since co-founding Array 17 years ago, Dr. Snitman has been
instrumental in creating strategic partnerships that have been key
to the growth and success of the company," said Mr. Squarer.
"The Array Board of Directors and I wish to thank him for his
dedication and service."
Novartis-Array Terms of the
Agreements
Effective March 2,
2015, Novartis' global, exclusive license to binimetinib
terminated with all rights reverting to Array, and Array received
global rights to encorafenib. Array will receive an
$85 million upfront payment from
Novartis and reimbursement for certain transaction-related
expenses. Novartis will provide transitional regulatory,
clinical development and manufacturing services as specified below
and will assign or license to Array patent and other intellectual
property rights it owns to the extent they relate to binimetinib
and encorafenib. All clinical trials involving binimetinib
and encorafenib currently sponsored by Novartis or Array, including
three pivotal trials, COLUMBUS (BRAF-mutant melanoma /
NCT01909453), NEMO (NRAS-mutant melanoma / NCT01763164), and MILO
(low-grade serous ovarian cancer / NCT01849874), will continue to
be conducted as currently contemplated.
Other than a de minimis payment to Novartis from Array, there
are no milestone payments or royalties payable between the parties
under the encorafenib agreement. As part of the transactions,
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. Array entered into a third party agreement
necessary to complete the transactions. Net consideration
Array agreed to pay amounts to $25
million. This payment is consistent with the earnings
guidance provided on the quarterly conference call held on
February 3, 2015.
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's 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 FTE costs
in connection with completing the trials.
Novartis will reimburse Array for all remaining out-of-pocket
expenses and half of all remaining FTE costs associated with MILO,
which Array will continue to conduct. For NEMO and all other
ongoing and planned clinical trials for binimetinib (other than
COLUMBUS, as described above), 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 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 and encorafenib 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 and 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 and binimetinib.
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 are
currently enrolling patients. These programs include two cancer
drugs, binimetinib (MEK162 / wholly-owned) and selumetinib
(AstraZeneca). 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 future development of binimetinib and encorafenib, the
timing of the completion or initiation of further development of
binimetinib and encorafenib, expectations that 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,
our ability to locate a suitable partner for binimetinib and
encorafenib, the impact of the third party payment by Array on our
results of operations, and our plans to build a late-stage
development 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 internal research and development efforts and
to create effective, commercially-viable drugs; 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; 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; 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; and our ability to attract and retain
experienced scientists and management. We are providing this
information as of March 2, 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:
|
Tricia
Haugeto
|
|
(303)
386-1193
|
|
thaugeto@arraybiopharma.com
|
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SOURCE Array BioPharma Inc.