THOUSAND
OAKS, Calif., Nov. 13,
2024 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today issued
the following statement on the MariTide (maridebart cafraglutide,
formerly AMG 133) Phase 1 data.
"As previously stated, Amgen does not see an association between
the administration of MariTide and bone mineral density changes.
The Phase 1 study results do not suggest any bone safety concern or
change our conviction in the promise of MariTide. We look forward
to sharing the Phase 2 topline data later this year."
Amgen Forward-Looking Statements
This communication
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collaborations, with any other company (including BeiGene, Ltd. or
Kyowa Kirin Co., Ltd.), the performance of Otezla® (apremilast)
(including anticipated Otezla sales growth and the timing of
non-GAAP EPS accretion), our acquisitions of Teneobio, Inc.,
ChemoCentryx, Inc., or Horizon Therapeutics plc (including the
prospective performance and outlook of Horizon's business,
performance and opportunities, any potential strategic benefits,
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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
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Even when clinical trials are successful, regulatory authorities
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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
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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
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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
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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, products or technology, and to
integrate the operations of companies or to support the products or
technology we have acquired, may not be successful. There can be no
guarantee that we will be able to realize any of the strategic
benefits, synergies or opportunities arising from the Horizon
acquisition, and such benefits, synergies or opportunities may take
longer to realize than expected. We may not be able to successfully
integrate Horizon, and such integration may take longer, be more
difficult or cost more than expected. A breakdown, cyberattack or
information security breach of our information technology systems
could compromise the confidentiality, integrity and availability of
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ability of our Board of Directors to declare a dividend or our
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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
Elissa Snook, 609-251-1407
(media)
Justin Claeys, 805-313-9775
(investors)
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SOURCE Amgen