THOUSAND OAKS, Calif.,
Oct. 27, 2020 /PRNewswire/ -- Amgen
(NASDAQ:AMGN) today announced that it has completed trial design
discussions through two Complex Innovative Trial Designs (CID)
Pilot Program meetings with the U.S. Food and Drug
Administration (FDA) for its planned Phase 2 efficacy and
safety trial for efavaleukin alfa (formerly known as AMG 592), an
investigational candidate for Systemic Lupus Erythematosus (SLE)
treatment. The CID Pilot Program aims to modernize drug
development, improve efficiency, and promote innovation. The
efavaleukin alfa participation in the CID Pilot Program is based on
an innovative adaptive clinical trial design developed to foster
the acceleration of a potential therapeutic option that could
benefit patients living with SLE.
"Systemic Lupus Erythematosus is an area with significant need
for new therapies for those living with the condition, but one that
has been challenging to address given the complexity of this
autoimmune disease," said Rob Lenz,
M.D., Ph.D., senior vice president, Global Development at Amgen.
"Our partnership with the FDA on the CID Pilot Program should drive
the development of a new treatment for lupus to address unmet need
for patients."
"Amgen welcomes the opportunity to partner with the FDA through
participation in the CID Pilot Program, which intends to advocate
innovative clinical trial designs, as well as provide the FDA an
opportunity to communicate these advances publicly," said
Steven Galson, M.D., senior vice
president, Global Regulatory Affairs and Strategy at Amgen. "We
appreciate the FDA's efforts, significant contributions and
feedback provided throughout the Pilot process."
The CID Pilot Program fulfills a performance goal agreed to
under the Prescription Drug User Fee Act (PDUFA) VI, aiming to
facilitate and advance the use of novel clinical trial designs that
support the development and regulatory review of new therapeutics.
Designs under the CID umbrella include, but are not limited to,
complex adaptive, Bayesian, and other novel clinical trial designs
which often require simulations to determine the statistical
properties of the trial. The FDA considers several eligibility
factors when selecting qualifying programs, including the level of
innovation of the trial design, and the therapeutic need.
About Systemic Lupus Erythematosus
Systemic Lupus
Erythematosus (SLE) is a chronic autoimmune disease that can impact
multiple organ systems leading to fatigue, kidney failure,
arthritis, rash and cardiovascular disease. While SLE disease
activity is variable, most patients continue to experience periods
of increased symptoms or flares which are associated with permanent
organ damage and is associated with increased risk of death due to
cardiovascular disease, infection and renal disease. Current
treatments for SLE aim to control the symptoms by suppressing the
immune response.
Efavaleukin alfa
Efavaleukin alfa is an IL-2 mutein Fc fusion protein. It is being
investigated for the treatment of inflammatory diseases, including
Systemic Lupus Erythematosus.
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.
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 collaborations, or potential
collaborations, with any other company, including BeiGene, Ltd. or
any collaboration or potential collaboration in pursuit of
therapeutic antibodies against COVID-19 (including statements
regarding such collaboration's, or our own, ability to discover and
develop fully-human neutralizing antibodies targeting SARS-CoV-2 or
antibodies against targets other than the SARS-CoV-2 receptor
binding domain, and/or to produce any such antibodies to
potentially prevent or treat COVID-19), 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, effects of pandemics or other widespread health problems
such as the ongoing COVID-19 pandemic on our business, outcomes,
progress, or effects relating to studies of Otezla as a potential
treatment for COVID-19, 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
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from concept to product is uncertain; consequently, there can be no
guarantee that any particular product candidate or development of a
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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,
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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
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Our results may be affected by our ability to successfully
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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. An outbreak of disease or similar public
health threat, such as COVID-19, and the public and governmental
effort to mitigate against the spread of such disease, could have a
significant adverse effect on the supply of materials for our
manufacturing activities, the distribution of our products, the
commercialization of our product candidates, and our clinical trial
operations, and any such events may have a material adverse effect
on our product development, product sales, business and results of
operations. 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
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a material adverse effect on sales of the affected products and on
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with or acquire other companies, products or technology, and to
integrate the operations of companies or to support the products or
technology we have acquired, may not be successful. A breakdown,
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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.
CONTACT: Amgen, Thousand
Oaks
Trish Rowland, 805-447-5631
(media)
Jessica Akopyan, 805-447-0974
(media)
Arvind Sood, 805-447-1060
(investors)
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SOURCE Amgen