BOULDER, Colo. and OSAKA, Japan, May 31, 2017 /PRNewswire/
-- Array BioPharma Inc. (Nasdaq: ARRY) and Ono
Pharmaceutical Co., Ltd. ("Ono") today announced a license,
development and commercialization partnership for Array's
late-stage novel oncology compounds, binimetinib and encorafenib.
As a result of this agreement, Ono will receive rights to develop
and commercialize binimetinib and encorafenib in Japan and South
Korea. Binimetinib, a MEK inhibitor, and encorafenib, a BRAF
inhibitor, are currently in two global Phase 3 trials, for the
treatment of patients with BRAF-mutant melanoma (COLUMBUS)
and BRAF-mutant colorectal cancer (BEACON CRC).
Under the terms of the agreement, Array will receive an upfront
payment of $31.6 million (¥3.5
billion) and retains exclusive commercialization rights for
binimetinib and encorafenib in the United
States, Canada and
Israel. Array is entitled to receive up to an additional
$156 million (¥17.3 billion) if
certain development and commercial milestones are achieved. A
portion of these milestones is related to the Phase 3 BEACON CRC
trial. In addition, Array will be eligible for robust,
tiered, double-digit royalties based on product sales in
Japan and South Korea. Ono
will obtain the right to conduct clinical trials of binimetinib and
encorafenib in Japan and
South Korea, as well as
participate in all future global development of binimetinib and
encorafenib by contributing 12% of those future costs.
"In Ono, we selected a market leader in immuno-oncology with a
rapidly growing product portfolio and recent track record of
successful development and commercialization in Japan," said Ron Squarer, Chief Executive
Officer, Array BioPharma. "This partnership allows us to remain
focused on commercializing binimetinib and encorafenib in the US,
while benefiting from Ono's clear expertise in these key
markets."
"We are very delighted to collaborate on binimetinib and
encorafenib with Array, a leading company with proven and
successful experience in research and development of molecularly
targeted therapy," said Gyo Sagara,
President, Representative Director and Chief Executive Officer,
Ono. "These two compounds have shown promising efficacy and safety
in the previous clinical trials and we believe that both compounds
can be a new therapeutic option as a combination therapy for
patients with BRAF-mutant melanoma, BRAF-mutant
colorectal cancer and beyond."
Binimetinib and encorafenib are investigational medicines and
are not currently approved in any country.
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. Seven Array
invented drugs are currently advancing in registration trials:
binimetinib (MEK162), encorafenib (LGX818), selumetinib (partnered
with AstraZeneca), danoprevir (partnered with Roche), larotrectinib
(partnered with Loxo Oncology), tucatinib (partnered with Cascadian
Therapeutics) and ipatasertib (partnered with Genentech). In
November 2015, Array entered into a
binimetinib and encorafenib agreement with Pierre Fabre, including a global development
partnership under which future development costs are shared 60:40
(Array:Pierre Fabre). As part of the agreement, Array
retained exclusive commercial rights to the US, Canada, Japan, South
Korea and Israel, while
Pierre Fabre gained exclusive
commercial rights to all other countries, including
Europe.
About Ono Pharmaceutical Co., Ltd.
Ono Pharmaceutical Co., Ltd., headquartered in Osaka, Japan, is an R&D-oriented
pharmaceutical company committed to creating innovative medicines
in specific areas. It focuses especially on the diabetes and
oncology areas. For more information, please visit the company's
website at http://www.ono.co.jp/eng/index.html.
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 potential to receive milestone and
royalty payments under the Agreement with Ono, the effectiveness of
the agreement with Ono, the timing of the announcement of the
results of clinical trials for the binimetinib and encorafenib
programs, the timing of the completion or initiation of further
development of the binimetinib and encorafenib programs, including
the timing of regulatory filings, expectations that events will
occur that will result in greater value for Array, and the
potential for the results of ongoing preclinical and clinical
trials to support regulatory approval or the marketing success of a
drug candidate. 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 relating to
the regulatory approval process for our drug candidates, which may
not result in approval for our drug candidates, cause delays in
development or require that we expend more resources to obtain
approval than expected; 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 May 31, 2017. 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