BOULDER, Colo., March 19, 2017 /PRNewswire/ -- Array
BioPharma Inc. (Nasdaq: ARRY) today announced that it has withdrawn
from the U.S. Food and Drug Administration's (FDA) Division of
Oncology Products 2 its new drug application (NDA) for binimetinib
monotherapy for the treatment of NRAS-mutant melanoma, a
rare, mutationally-driven subset of skin cancer.
This action was based on thorough discussions and communications
with the FDA, including exploration of various paths to approval,
and followed the late cycle review meeting held with the FDA on
Friday, March 17, 2017. Based
on feedback from the agency, Array concluded that the clinical
benefit demonstrated in the Phase 3 NEMO clinical trial would not
be found sufficient to support approval of the NRAS-mutant
melanoma NDA.
Ongoing clinical trials for binimetinib will continue. This
action will not impact the planned Phase 3 COLUMBUS trial NDA of
binimetinib, in combination with encorafenib, for the treatment of
BRAF-mutant melanoma, which remains on track for
mid-2017.
About NRAS-Mutant Melanoma
Of the estimated
10,000 annual cases of metastatic melanoma in the United States, activating NRAS
mutations are present in approximately 20 percent of these
patients. The presence of an NRAS mutation is a poor
prognostic indicator for these patients, and treatment options for
this population remain limited beyond immunotherapy.
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 registration studies
are currently advancing related to six Array-owned or partnered
drugs: binimetinib (MEK162), encorafenib (LGX818), selumetinib
(partnered with AstraZeneca), danoprevir (partnered with Roche),
larotrectinib (partnered with Loxo Oncology) and tucatinib
(partnered with Cascadian Therapeutics).
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 timing of the announcement of the results of clinical
trials for our proprietary and our partnered programs, the timing
of the completion or initiation of further development of our
wholly-owned and our partnered programs, including the timing of
regulatory filings, 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 partner our proprietary drug candidates for up-front fees,
milestone and/or royalty payments, our future plans to progress and
develop our proprietary programs, our future capital requirements
and the plans of our collaborators to progress and develop programs
we have licensed to them, 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 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 March 19, 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 Inc.