THOUSAND OAKS, Calif.,
June 22, 2020 /PRNewswire/ -- Amgen
(NASDAQ: AMGN) today announced it is supporting the further study
of AMG 634, a phosphodiesterase type 4 (PDE4) inhibitor, for the
treatment of tuberculosis (TB) and erythema nodosum leprosum (ENL),
an inflammatory cutaneous and systemic complication of
leprosy. Amgen acquired AMG 634 (formerly CC-11050) as part
of its acquisition of Otezla® (apremilast) from
Celgene in 2019. AMG 634 is currently in Phase 2 studies led by The
Aurum Institute NPC (TB study) and The Leprosy Mission Nepal (ENL
study).
"AMG 634 could have potential for patients suffering from ENL
and TB, two diseases that continue to challenge many countries
around the world," said David M.
Reese, M.D. executive vice president of Research and
Development at Amgen. "We believe that the right organization
focused on global health will be able to help further develop the
molecule and get it directly into the hands of those patients in
need of treatment options."
Approximately 225,000 new cases of leprosy are identified every
year1, and a significant number of leprosy patients
suffer from ENL, an autoimmune complication that can occur many
years after being cured of leprosy and can cause permanent nerve
damage and disability2. Tuberculosis affects 10.4
million patients every year and causes over one million deaths.
Current treatments are often inadequate and can leave patients with
permanent, clinically significant lung damage3.
While intending to support the two Phase 2 clinical trials in
ENL and TB set to begin in 2021 by providing study drug, Amgen is
interested in partnering these programs with a non-government
organziation (NGO) for further development.
More information about the clinical trial in ENL can be found
here and in TB can be found here.
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
collaborations, or potential collaborations, with any other
company, including Adaptive Biotechnologies (including statements
regarding such collaboration's ability to discover and develop
fully-human neutralizing antibodies targeting SARS-CoV-2 to
potentially prevent or treat COVID-19), BeiGene, Ltd., or the
Otezla 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. 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,
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Furthermore, our research, testing, pricing, marketing and other
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CONTACT: Amgen, Thousand Oaks
Megan Fox, 805-447-1423 (media)
Trish Rowland, 805-447-5631
(media)
Arvind Sood, 805-447-1060
(investors)
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1 World
Health Organization website
https://www.who.int/news-room/fact-sheets/detail/leprosy (last
accessed June 15, 2020)
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2
Saunderson P, Gebre S, Byass P. ENL reactions in the multi
bacillary cases of the AMFES cohort in central Ethiopia: incidence
and risk factors. Lepr Rev (2000) 71, 3 1
8-324
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3 Bloom
BR, Atun R, Cohen T, et al. Tuberculosis. In: Holmes KK, Bertozzi
S, Bloom BR, et al., editors. Major Infectious Diseases. 3rd
edition. Washington (DC): The International Bank for Reconstruction
and Development / The World Bank; 2017 Nov 3. Chapter 11. Available
from: https://www.ncbi.nlm.nih.gov/books/NBK525174/ doi:
10.1596/978-1-4648-0524-0_ch11
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