BOULDER, Colo., Nov. 16, 2015 /PRNewswire/ -- Array BioPharma
Inc. (Nasdaq: ARRY) and Pierre Fabre today announced a
collaboration to globally develop and commercialize Array's
late-stage novel oncology products, binimetinib and encorafenib.
Binimetinib, a MEK inhibitor, and encorafenib, a BRAF inhibitor,
are currently advancing in three, global Phase 3 trials for
melanoma and ovarian cancer. Top-line results from NEMO, a Phase 3
study of binimetinib in patients with NRAS-mutant melanoma, are
anticipated before the end of 2015. Array plans to host a
conference call on November 16, 2015
at 9:00 am ET to discuss the
collaboration.
Under the terms of the agreement, Array will receive an upfront
payment of $30 million and retains
exclusive commercialization rights for binimetinib and encorafenib
in the United States, Canada, Japan, Korea and Israel. Pierre Fabre will have exclusive rights to
commercialize both products in all other countries, including
Europe, Asia and Latin
America. Array is entitled to receive up to $425 million if certain development and
commercialization milestones are achieved, and is eligible for
robust, tiered double-digit royalties. Array and Pierre Fabre have agreed to split future
development costs on a 60:40 basis (Array:Pierre Fabre) with
initial funding committed for new clinical trials in colorectal
cancer and melanoma. All ongoing binimetinib and encorafenib
clinical trials remain substantially funded through completion by
Novartis.
Pierre Fabre Oncology, a business unit of the global
10,000-employee Pierre Fabre
company, is supported by over 1,000 employees with a strong focus
on European markets. In 2014, worldwide annual sales of
Pierre Fabre Oncology products surpassed $200 million on the strength of the Oral
Navelbine, Javlor and Busilvex brands. In addition, Pierre Fabre has a significant commitment and
track record in pharmaceutical R&D, developing products for
patients afflicted with lung, breast and other solid tumors and
hematological cancers.
"In Pierre Fabre we selected a partner with a European and
emerging market focus in oncology to develop and commercialize
binimetinib and encorafenib in these geographies," said Ron
Squarer, Chief Executive Officer, Array BioPharma. "With Phase 3
trials approaching data readouts, and over 30 additional Phase 1/2
trials underway, we are confident that binimetinib and encorafenib
are well positioned for near-term regulatory submissions and
significant commercial value."
"Pierre Fabre is strongly
committed to develop and commercialize oncology products," said
Frederic Duchesne, Chief Executive
Officer, Pierre Fabre Pharmaceuticals. "This partnership with Array
is aligned with our growth strategy in Pharmaceuticals, our
geographic footprint, and our corporate mission to bring to
the market novel oncology products which address unmet patient
needs. Binimetinib and encorafenib will fit perfectly with our
broad expertise in oncology and dermatology, and will
strengthen our current portfolio and international presence."
The agreement remains subject to European Commission on
Competition review and approval.
CONFERENCE CALL INFORMATION
Array will hold a
conference call on Wednesday, November 16,
2015 at 9:00 a.m. Eastern Time
to discuss these results. Ron Squarer, Chief Executive
Officer will lead the call.
Date:
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Monday, November 16,
2015
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Time:
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9:00 a.m. Eastern
Time
|
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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80617598
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Webcast, including
Replay and Conference Call Slides:
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http://edge.media-server.com/m/p/x7ng6en5/lan/en
|
About Binimetinib and Encorafenib
RAF and MEK are key protein kinases in the RAS/RAF/MEK/ERK pathway.
Research has shown this pathway regulates several key cellular
activities including proliferation, differentiation, migration,
survival and angiogenesis. Inappropriate activation of proteins in
this pathway has been shown to occur in many cancers, such as
non-small cell lung cancer, melanoma, colorectal, ovarian and
thyroid cancers. Binimetinib is a small molecule MEK inhibitor
and encorafenib is a small molecule BRAF inhibitor, both of which
target key enzymes in this pathway. Three Phase 3 trials in
advanced cancer patients continue to advance: NRAS-mutant melanoma
(NEMO, with binimetinib), low-grade serous ovarian cancer (MILO,
with binimetinib) and BRAF-mutant melanoma (COLUMBUS, with
binimetinib and encorafenib). NRAS-mutant melanoma represents the
first potential indication for binimetinib, with a projected
regulatory filing estimated in the first half of 2016. Array also
projects a regulatory filing of binimetinib in combination with
encorafenib in BRAF melanoma in 2016.
About Pierre Fabre
Pierre Fabre is a French
privately-owned health and beauty care company created in 1961 by
Mr. Pierre Fabre. In 2014, global
sales reached €2.1 billion across 130 countries. The company is
structured around two divisions: Pharmaceuticals (Prescription
drugs, Consumer Health Care) and Dermo-cosmetics (including the
European and Asian market-leader Eau Thermale Avene brand).
Pierre Fabre employs some 10,000
people worldwide and owns subsidiary in 43 countries. In 2014, the
company allocated 17 percent of its pharmaceuticals sales to
R&D with a focus on 4 therapeutic areas: oncology, dermatology,
CNS and consumer health care.
Pierre Fabre's oncology know-how
is based on 3 decades of experience in the discovery, development
and global commercialization of innovative cancer drugs including
monoclonal antibodies and natural cytotoxic agents. The company
performs its oncology R&D in two major research centres: the
Pierre Fabre Immunology Centre (CIPF) based in
Saint-Julien-en-Genevois (France)
and the Pierre Fabre Research Institute (IRPF) located on the
Toulouse-Oncopole campus. The latter is officially recognized by
the French government as a National Center of Excellence for cancer
research.
For more information on Pierre
Fabre, please go to www.pierre-fabre.com.
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
registration studies are currently advancing related to three
cancer drugs. These programs include binimetinib (MEK162),
encorafenib (LGX818) and selumetinib (AstraZeneca). For more
information on Array, please go to www.arraybiopharma.com.
Array BioPharma 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 Pierre
Fabre, the effectiveness of the agreement with Pierre Fabre, 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, the willingness of the European Commission on
Competition to approve the agreement with Pierre Fabre; 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; and our ability to attract
and retain experienced scientists and management. We are providing
this information as of November 16,
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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Kathy
McConnell
|
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Gregory FCA
|
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610-228-2149
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kmcconnell@gregoryfca.com
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SOURCE Array BioPharma Inc.