THOUSAND OAKS, Calif.,
Jan. 13, 2020 /PRNewswire/ -- Amgen
(NASDAQ: AMGN) today announced strategic collaborations with
leading diagnostic companies Guardant Health, Inc. and QIAGEN N.V.
to develop blood- and tissue-based companion diagnostics (CDx),
respectively, for investigational cancer treatment AMG 510. AMG 510
is the first KRASG12C inhibitor to advance to the clinic
for investigation in treatment of multiple tumor types. KRAS
G12C is one of the most frequently mutated oncogenes in human
cancers. The agreements with both companies will initially focus on
CDx tests for non-small cell lung cancer (NSCLC) but allow for
further development of the diagnostic tests for Amgen's other
oncology clinical development programs.
"Amgen is committed to driving broad accessibility to biomarker
testing in order to select appropriate patients who will directly
benefit from targeted treatments," said David M. Reese, M.D., executive vice president
of Research and Development at Amgen. "With one in eight
patients with NSCLC having KRAS G12C, there's a critical
need to improve access to high quality diagnostics and more routine
screening. Collaborating with QIAGEN and Guardant Health to have
both tissue- and blood-based diagnostic tests available will help
to identify patients with NSCLC who may benefit from AMG 510."
Amgen will work with QIAGEN to develop a tissue-based diagnostic
test utilizing its therascreen® platform to
identify patients whose cancers have the KRAS G12C mutation.
QIAGEN will also pursue global regulatory approvals, including
Pre-Market Approval (PMA) from the U.S. Food and Drug
Administration (FDA). To enable biomarker testing in patients for
whom insufficient tissue remains a challenge, Amgen is also
collaborating with Guardant Health to develop a liquid biopsy CDx.
Guardant360 CDx is a multi-tumor comprehensive NGS (Next Generation
Sequencing) test that is being developed to identify patients with
actionable alterations, in this instance with the KRAS G12C
mutation in NSCLC. Guardant Health will seek global regulatory
approvals for the test, including a PMA from the FDA.
AMG 510 is currently enrolling patients in a potentially
registrational Phase 2 study (CodeBreak™ 100). The FDA
granted Orphan Drug Designation to AMG 510 for previously treated
metastatic NSCLC and colorectal cancer with KRAS G12C
mutation and Fast Track Designation for previously treated
metastatic NSCLC with KRAS G12C mutation.
Amgen established RAS as the first actionable biomarker
in metastatic colorectal cancer and is now pioneering the
development of KRAS mutation specific inhibitors in lung
cancer and other solid tumors with AMG 510.
About
KRAS
The subject of almost four decades of research, the RAS gene
family are the most frequently mutated oncogenes in human
cancers.1,2 Within this family, KRAS is the most
prevalent variant and is particularly common in solid
tumors.2 A specific mutation known as KRAS G12C
is found in approximately 13% of non-small cell lung cancers, three
to five percent of colorectal cancers and one to two percent of
numerous other solid tumors.3 KRASG12C has
been considered "undruggable" due to a lack of traditional small
molecule binding pockets on the protein.4 Amgen is
exploring the potential of KRASG12C inhibition across a
broad variety of tumor types.
About Amgen Oncology
Amgen Oncology is searching for and finding answers to incredibly
complex questions that will advance care and improve lives for
cancer patients and their families. Our research drives us to
understand the disease in the context of the patient's life – not
just their cancer journey – so they can take control of their
lives.
For the last four decades, we have been dedicated to discovering
the firsts that matter in oncology and to finding ways to reduce
the burden of cancer. Building on our heritage, Amgen continues to
advance the largest pipeline in the Company's history, moving with
great speed to advance those innovations for the patients who need
them.
At Amgen, we are driven by our commitment to transform the lives
of cancer patients and keep them at the center of everything we
do.
For more information, follow us on
www.twitter.com/amgenoncology.
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.
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 any statements on the outcome, benefits and synergies of
collaboration with any other company, including BeiGene, Ltd.,
or the Otezla® (apremilast) acquisition, including
anticipated Otezla sales growth and the timing of non-GAAP EPS
accretion, as well as 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 our most
recent annual report on Form 10-K and any subsequent periodic
reports on Form 10-Q and current reports on 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 we project. 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, preclinical results do not
guarantee safe and effective performance of product candidates in
humans. The complexity of the human body cannot be perfectly, or
sometimes, even adequately modeled by computer or cell culture
systems or animal models. The length of time that it takes for us
to complete clinical trials and obtain regulatory approval for
product marketing has in the past varied and we expect similar
variability in the future. Even when clinical trials are
successful, regulatory authorities may question the sufficiency for
approval of the trial endpoints we have selected. We develop
product candidates internally and through licensing collaborations,
partnerships and joint ventures. Product candidates that are
derived from relationships may be subject to disputes between the
parties or may prove to be not as effective or as safe as we may
have believed at the time of entering into such relationship. Also,
we or others could identify safety, side effects or manufacturing
problems with our products, including our devices, after they are
on the market.
Our results may be affected by our 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 our products and global
economic conditions. In addition, sales of our 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, our research, testing,
pricing, marketing and other operations are subject to extensive
regulation by domestic and foreign government regulatory
authorities. Our business may be impacted by government
investigations, litigation and product liability claims. In
addition, our business may be impacted by the adoption of new tax
legislation or exposure to additional tax liabilities. If we fail
to meet the compliance obligations in the corporate integrity
agreement between us and the U.S. government, we could become
subject to significant sanctions. Further, while we routinely
obtain patents for our products and technology, the protection
offered by our patents and patent applications may be challenged,
invalidated or circumvented by our competitors, or we may fail to
prevail in present and future intellectual property litigation. We
perform a substantial amount of our commercial manufacturing
activities at a few key facilities, including in Puerto Rico,
and also depend on third parties for a portion of our manufacturing
activities, and limits on supply may constrain sales of certain of
our current products and product candidate development. We rely on
collaborations with third parties for the development of some of
our product candidates and for the commercialization and sales of
some of our commercial products. In addition, we compete with other
companies with respect to many of our marketed products as well as
for the discovery and development of new products. Further, some
raw materials, medical devices and component parts for our products
are supplied by sole third-party suppliers. Certain of our
distributors, customers and payers have substantial purchasing
leverage in their dealings with us. The discovery of significant
problems with a product similar to one of our products that
implicate an entire class of products could have a material adverse
effect on sales of the affected products and on our business and
results of operations. Our efforts to collaborate with or acquire
other companies or products, and to integrate the operations of
companies or in support of products we have acquired, may not be
successful. A breakdown, cyberattack or information security breach
could compromise the confidentiality, integrity and availability of
our systems and our data. Our stock price is volatile and may be
affected by a number of events. Our business performance could
affect or limit the ability of our Board of Directors to declare a
dividend or our ability to pay a dividend or repurchase our common
stock. We may not be able to access the capital and credit markets
on terms that are favorable to us, or at all.
The scientific information discussed in this news release
related to our product candidates is preliminary and investigative.
Such product candidates are not approved by the U.S. Food and
Drug Administration, and no conclusions can or should be drawn
regarding the safety or effectiveness of the product candidates.
Further, any scientific information discussed in this news release
relating to new indications for our products is preliminary and
investigative and is not part of the labeling approved by
the U.S. Food and Drug Administration for the products.
The products are not approved for the investigational use(s)
discussed in this news release, and no conclusions can or should be
drawn regarding the safety or effectiveness of the products for
these uses.
CONTACT: Amgen, Thousand
Oaks
Jessica Akopyan, 805-447-0974
(Media)
Trish Hawkins, 805-447-5631
(Media)
Arvind Sood, 805-447-1060
(Investors)
References:
- Cox A, et al. Drugging the undruggable RAS: Mission
possible? Nat Rev Drug Discov. 2014;13:828-851.
- Fernandez-Medarde A, Santos E. Ras in cancer and
developmental diseases. Genes Cancer.
2011;2:344-358.
- Lipford, JR. Pre-clinical development of AMG 510: the first
inhibitor of KRASG12C in clinical testing. Oral
presentation at AACR 2019, Atlanta, GA. March 29-April 3, 2019.
- Stephen AG, et al. Dragging ras back in the ring. Cancer
Cell. 201417;25:272-281.
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SOURCE Amgen