THOUSAND OAKS, Calif. and
BOULDER, Colo., July 18, 2017 /PRNewswire/ -- Amgen (NASDAQ:AMGN)
and Array BioPharma (NASDAQ:ARRY) today announced a collaboration
agreement for the discovery and development of novel drugs for
autoimmune disorders. The undisclosed target and lead inhibitors
were discovered through Array's proprietary platform that leverages
Array's expertise in chemistry and early lead
development.
"We are pleased to enter this collaboration with Array that
builds on our continued focus in inflammation, one of Amgen's key
strategic areas of interest," said Flavius
Martin, M.D., vice president of Research, Inflammation and
Oncology at Amgen. "We look forward to partnering with Array
BioPharma to advance molecules into the clinic that may offer a new
treatment option for patients."
"We look forward to collaborating with Amgen, a leader in
treatments for inflammatory disease, on this exciting target which
was discovered using Array's proprietary Kinase-Directed Phenotypic
Screening Platform," said Nicholas A.
Saccomano, Ph.D., chief scientific officer at Array
BioPharma. "The identification of this novel target, along with our
team's deep experience in kinase inhibitor chemistry, gives us
confidence that our efforts will result in a drug which will
address a significant unmet medical need for patients with
inflammatory disease."
Under the terms of the agreement, Amgen and Array will
collaborate on preclinical development with Array leading the
medicinal chemistry work. Amgen is responsible for clinical
development and commercialization. In exchange for exclusive rights
to Array's preclinical program, Amgen will make upfront and
milestone payments, as well as pay royalties on sales of resulting
therapies.
About Amgen
Amgen is committed to unlocking
the potential of biology for patients suffering from serious
illnesses by discovering, developing, manufacturing and delivering
innovative human therapeutics. This approach begins by using tools
like advanced human genetics to unravel the complexities of disease
and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and
leverages its expertise to strive for solutions that improve health
outcomes and dramatically improve people's lives. A biotechnology
pioneer since 1980, Amgen has grown to be one of the
world's leading independent biotechnology companies, has reached
millions of patients around the world and is developing a pipeline
of medicines with breakaway potential.
For more information, visit www.amgen.com and follow
us on www.twitter.com/amgen.
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. Eight 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),
ipatasertib (partnered with Genentech), larotrectinib (partnered
with Loxo Oncology) and tucatinib (partnered with Cascadian
Therapeutics).
Amgen Forward-Looking Statements
This news
release contains forward-looking statements that are based on the
current expectations and beliefs of Amgen. All statements, other
than statements of historical fact, are statements that could be
deemed forward-looking statements, including estimates of revenues,
operating margins, capital expenditures, cash, other financial
metrics, expected legal, arbitration, political, regulatory or
clinical results or practices, customer and prescriber patterns or
practices, reimbursement activities and outcomes and other such
estimates and results. Forward-looking statements involve
significant risks and uncertainties, including those discussed
below and more fully described in the Securities and Exchange
Commission reports filed by Amgen, including its most recent annual
report on Form 10-K and any subsequent periodic reports on Form
10-Q and Form 8-K. Unless otherwise noted, Amgen is providing
this information as of the date of this news release and does not
undertake any obligation to update any forward-looking statements
contained in this document as a result of new information, future
events or otherwise.
No forward-looking statement can be guaranteed and actual
results may differ materially from those Amgen project. Amgen's
results may be affected by its ability to successfully market both
new and existing products domestically and internationally,
clinical and regulatory developments involving current and future
products, sales growth of recently launched products, competition
from other products including biosimilars, difficulties or delays
in manufacturing its products and global economic conditions. In
addition, sales of Amgen's products are affected by pricing
pressure, political and public scrutiny and reimbursement policies
imposed by third-party payers, including governments, private
insurance plans and managed care providers and may be affected by
regulatory, clinical and guideline developments and domestic and
international trends toward managed care and healthcare cost
containment. Furthermore, Amgen's research, testing, pricing,
marketing and other operations are subject to extensive regulation
by domestic and foreign government regulatory authorities. Amgen or
others could identify safety, side effects or manufacturing
problems with its products after they are on the market. Amgen's
business may be impacted by government investigations, litigation
and product liability claims. In addition, Amgen's business may be
impacted by the adoption of new tax legislation or exposure to
additional tax liabilities. If Amgen fails to meet the compliance
obligations in the corporate integrity agreement between it and the
U.S. government, Amgen could become subject to significant
sanctions. Further, while Amgen routinely obtains patents for its
products and technology, the protection offered by its patents and
patent applications may be challenged, invalidated or circumvented
by its competitors, or Amgen may fail to prevail in present and
future intellectual property litigation. Amgen performs a
substantial amount of its commercial manufacturing activities at a
few key manufacturing facilities and also depends on third parties
for a portion of its manufacturing activities, and limits on supply
may constrain sales of certain of its current products and product
candidate development. In addition, Amgen competes with other
companies with respect to many of its marketed products as well as
for the discovery and development of new products. Discovery or
identification of new product candidates or development of new
indications for existing products cannot be guaranteed and movement
from concept to product is uncertain; consequently, there can be no
guarantee that any particular product candidate or development of a
new indication for an existing product will be successful and
become a commercial product. Further, some raw materials, medical
devices and component parts for Amgen's products are supplied by
sole third-party suppliers. Certain of Amgen's distributors,
customers and payers have substantial purchasing leverage in their
dealings with Amgen. The discovery of significant problems with a
product similar to one of Amgen's products that implicate an entire
class of products could have a material adverse effect on sales of
the affected products and on its business and results of
operations. Amgen's efforts to acquire other companies or products
and to integrate the operations of companies Amgen has acquired may
not be successful. Amgen may not be able to access the capital and
credit markets on terms that are favorable to it, or at all. Amgen
is increasingly dependent on information technology systems,
infrastructure and data security. Amgen's stock price may be
volatile and may be affected by a number of events. Amgen's
business performance could affect or limit the ability of the Amgen
Board of Directors to declare a dividend or its ability to pay a
dividend or repurchase its common stock.
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 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 July 18, 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:
Amgen, Thousand
Oaks
Kristen Davis,
805-447-3008 (Media)
Kristen Neese, 805-313-8267
(Media)
Arvind Sood, 805-447-1060
(Investors)
Array, Boulder
Tricia
Haugeto
303-386-1193
thaugeto@arraybiopharma.com
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SOURCE Amgen; Array BioPharma