THOUSAND OAKS, Calif.,
Sept. 13, 2021 /PRNewswire/
-- Amgen (NASDAQ: AMGN) today announced that new data from its
expanding inflammation pipeline and marketed portfolio will be
presented at the European Academy of Dermatology and Venereology
(EADV) 30th Congress, which will take place virtually
Sept. 29 – Oct. 2.
In a late-breaking data presentation, detailed results from a
Phase 2 moderate-to-severe atopic dermatitis study of AMG
451/KHK4083, a potential first-in-class anti-OX40 monoclonal
antibody jointly under development by Amgen and Kyowa Kirin Co.,
Ltd. (TSE: 4151) for the treatment of moderate-to-severe atopic
dermatitis, will be presented. Additionally, new 32-week outcomes
data from the Phase 3 ADVANCE trial investigating the efficacy and
safety of Otezla® (apremilast) to improve psoriasis
symptoms and involvement in special areas (scalp or nails) in
adults with mild-to-moderate plaque psoriasis will also be
presented.
"Amgen looks forward to sharing new late-breaking research at
EADV alongside our partners at Kyowa Kirin, highlighting a
potential new treatment option for the millions of people worldwide
with moderate-to-severe atopic dermatitis," said David M. Reese, M.D., executive vice president
of Research and Development at Amgen. "We are deeply committed to
driving innovation in dermatologic inflammatory diseases, and this
research – as well as other data for presentation from across our
portfolio – demonstrates the important strides we are making to
help improve outcomes for patients with these serious skin
conditions."
Inflammation Pipeline Abstracts
- Efficacy and safety results of KHK4083/AMG 451 (anti-OX40
mAb) in subjects with moderate to severe atopic dermatitis: a phase
2, multicentre, randomized, double-blind, parallel-group,
placebo-controlled study
-
- Abstract #D3T01.1B, Late-breaking Oral Presentation, Session:
Late-breaking News, Saturday, Oct. 2
from 10:15-10:30 am CEST
Otezla Clinical Data Abstracts
- Improvement in Psoriasis Symptoms and Involvement in Special
Areas: 32-Week Results From ADVANCE
-
- Abstract #P1425, E-Poster, Session: Psoriasis, Wednesday, Sept. 29 from 6
am-11:59 pm CEST
- Improvement in Patient- and Physician-Reported Outcomes With
Apremilast Treatment in Patients With Mild to Moderate Plaque
Psoriasis in the Phase 3 ADVANCE Trial: Results of Subgroup
Analyses by Baseline Psoriasis-Involved BSA and PASI
-
- Abstract #P1334, E-Poster, Session: Psoriasis, Sept. 29 from 6 am-11:59
pm CEST
- Efficacy of Apremilast in Mild to Moderate Psoriasis
Including Special Areas and Itch: 32-Week Results From the
PROMINENT Study in Japan
-
- Abstract #P1352, E-Poster, Session: Psoriasis, Sept. 29 from 6 am-11:59
pm CEST
- Efficacy and Safety of Apremilast in Japanese Patients With
Mild to Moderate Psoriasis: 32-Week Results From PROMINENT
-
- Abstract #P1422, E-Poster, Session: Psoriasis, Sept. 29 from 6 am-11:59
pm CEST
Real-World Study Abstracts
- Differences in Patient and Dermatologist Perspectives on
Psoriasis Treatment: Results From the UPLIFT Survey
-
- Abstract #FC03.01, Oral Presentation, Session: Free
Communications, Sept. 30 from
2:30-2:40 pm CEST
- Greater Disease Burden in Patients With Psoriasis Who Report
Joint Pain Without a Diagnosis of Psoriatic Arthritis: Results From
the 2020 UPLIFT Survey
-
- Abstract #P1465, E-Poster, Session: Psoriasis, Sept. 29 from 6 am-11:59
pm CEST
- Analysis of Real-world Systemic-Naive Patients With Mild or
Moderate vs Severe Plaque Psoriasis: Patient Characteristics and
Disease Burden Findings From CorEvitas' Psoriasis Registry
-
- Abstract #P1409, E-Poster, Session: Psoriasis, Sept. 29 from 6 am-11:59
pm CEST
Abstracts can be found on the EADV website.
Amgen Webcast Investor Call
Amgen will host a webcast
call for the investment community at 8:30
a.m. ET on Monday, Oct. 4, 2021. David M. Reese, M.D., executive vice president
of Research and Development at Amgen, along with other members of
Amgen's management team, will discuss clinical data being presented
at EADV, including data from the AMG 451/KHK4083 Phase 2 trial in
patients with moderate-to-severe atopic dermatitis, as well as the
broader inflammation portfolio.
Live audio of the conference call will be broadcast over the
internet simultaneously and will be available to members of the
news media, investors and the general public.
The webcast, as with other selected presentations regarding
developments in Amgen's business given at certain investor and
medical conferences, can be accessed on Amgen's website,
www.amgen.com, under Investors. Information regarding presentation
times, webcast availability and webcast links are noted on Amgen's
Investor Relations Events Calendar. The webcast will be archived
and available for replay for at least 90 days after the event.
About the AMG 451/KHK4083 Phase 2 Study
The Phase 2,
multicenter, randomized, double-blind, placebo-controlled trial
(NCT03703102) investigated the efficacy and safety of AMG
451/KHK4083 in adults with moderate-to-severe atopic dermatitis who
were not adequately controlled with topical agents. The study
randomized 274 patients in the U.S., Japan, Canada
and Germany across four
dose-ranging active treatment arms, which received subcutaneous AMG
451/KHK4083, and a comparator placebo arm.
The primary endpoint was percentage change from baseline in
Eczema Area and Severity Index (EASI) score at week 16.
About Atopic Dermatitis
Atopic dermatitis is a chronic
inflammatory disease that causes excessively dry, itchy skin that
can be painful. Repeated scratching can cause the skin to thicken,
harden or become vulnerable to infection. Atopic dermatitis is the
most common form of eczema – affecting 15-20% of children and 1-3%
of adults worldwide – and the prevalence is increasing. The disease
typically manifests in childhood followed by other allergy
symptoms.
About AMG 451/KHK4083
AMG 451/KHK4083 is an anti-OX40
fully human monoclonal antibody engineered with Kyowa Kirin's
patented POTELLIGENT® defucosylation technology to
enhance its antibody-dependent cellular cytotoxicity (ADCC)
activity. The initial AMG 451/KHK4083 antibody was discovered in
collaboration between Kyowa Kirin US Research and La Jolla
Institute for Immunology. AMG 451/KHK4083 targets and inhibits the
activity of the OX40 receptor expressed on the surface of effector
T-cells, and has been shown to deplete activated OX40+
T-cells by ADCC. It has been reported that effector T cells
expressing OX40 are present in the lesions of patients with atopic
dermatitis and are critical in their development.
Amgen and Kyowa Kirin Collaboration
On June 1, 2021, Amgen (NASDAQ:AMGN) entered into an
agreement with Kyowa Kirin (TSE: 4151) to jointly develop and
commercialize AMG 451/KHK4083. Under the terms of the agreement,
Amgen will lead the development, manufacturing, and
commercialization of AMG 451/KHK4083 for all markets globally,
except Japan, where Kyowa Kirin
will retain all rights. If approved, the companies will co-promote
the asset in the United States and
Kyowa Kirin has opt-in rights to co-promote it in certain other
markets including Europe and
Asia.
About ADVANCE (PSOR-022)
ADVANCE (NCT03721172) is a
Phase 3, multicenter, randomized, placebo-controlled, double-blind
study evaluating the efficacy and safety of Otezla in patients with
mild-to-moderate plaque psoriasis (defined as BSA involvement of 2%
to 15%, Psoriasis Area and Severity Index (PASI) score of 2 to 15,
Physician's Global Assessment (sPGA) score of 2 to 3). The study
randomized 595 patients 1:1 to receive Otezla (n=297) 30 mg twice
daily or placebo (n=298) for the first 16 weeks. All patients then
received Otezla during an open-label extension phase through week
32.
The primary endpoint was the percentage of patients with sPGA
response [defined as a sPGA score of clear (0) or almost clear (1)
with at least a 2-point reduction from baseline] at week 16.
About PROMINENT
PROMINENT (NCT03930186) is Phase
3b, multicenter, open-label,
single-arm study evaluating the efficacy and safety of Otezla in
Japanese patients with mild-to-moderate psoriasis (sPGA score of 2
to 3) not adequately controlled by topical therapy. The study
recruited 152 patients to receive Otezla 30 mg twice daily for 32
weeks on top of their existing topical therapy.
The primary endpoint was percentage of patients who achieved an
sPGA score of 0 or 1 at week 16.
About the UPLIFT Survey
In 2020, Amgen conducted the
global Understanding Psoriatic Disease Leveraging Insights for
Treatment (UPLIFT) survey exploring the evolution of attitudes and
behaviors of 3,806 people living with psoriasis and psoriatic
arthritis, 473 dermatologists and 450 rheumatologists in eight
countries in North America,
Europe and Asia. The survey was conducted in 2020 and was
overseen by an academic steering committee of thought-leaders in
dermatology and rheumatology. The survey builds upon findings from
the 2012 Multinational Assessment of Psoriasis and Psoriatic
Arthritis (MAPP) survey, a first-of-its-kind study conducted by
Celgene that looked in-depth at the effect of psoriasis and
psoriatic arthritis on people living with these conditions.
About Psoriasis
Psoriasis is a serious, chronic
inflammatory disease that causes raised, red, scaly patches to
appear on the skin, typically affecting the outside of the elbows,
knees or scalp, though it can appear on any
location.1 Approximately 125 million people
worldwide have psoriasis, including around 14 million people in
Europe and more than 7.5 million
people in the United
States.2,3 About 80% of those patients have
plaque psoriasis.4
About Otezla®
(apremilast)
OTEZLA® (apremilast) is an oral
small-molecule inhibitor of phosphodiesterase 4 (PDE4) specific for
cyclic adenosine monophosphate (cAMP). PDE4 inhibition results in
increased intracellular cAMP levels, which is thought to indirectly
modulate the production of inflammatory mediators. The specific
mechanism(s) by which Otezla exerts its therapeutic action in
patients is not well defined.
Otezla® (apremilast) U.S.
INDICATIONS
Otezla® (apremilast) is indicated for the treatment of
adult patients with moderate to severe plaque psoriasis who are
candidates for phototherapy or systemic therapy.
Otezla is indicated for the treatment of adult patients with
active psoriatic arthritis.
Otezla is indicated for the treatment of adult patients with
oral ulcers associated with Behçet's Disease.
Otezla® (apremilast) U.S. IMPORTANT SAFETY
INFORMATION
Contraindications
- Otezla® (apremilast) is contraindicated in patients
with a known hypersensitivity to apremilast or to any of the
excipients in the formulation
Warnings and Precautions
- Diarrhea, Nausea, and Vomiting: Cases of severe diarrhea,
nausea, and vomiting were associated with the use of Otezla. Most
events occurred within the first few weeks of treatment. In some
cases, patients were hospitalized. Patients 65 years of age or
older and patients taking medications that can lead to volume
depletion or hypotension may be at a higher risk of complications
from severe diarrhea, nausea, or vomiting. Monitor patients who are
more susceptible to complications of diarrhea or vomiting; advise
patients to contact their healthcare provider. Consider Otezla dose
reduction or suspension if patients develop severe diarrhea,
nausea, or vomiting
- Depression: Carefully weigh the risks and benefits of treatment
with Otezla for patients with a history of depression and/or
suicidal thoughts/behavior, or in patients who develop such
symptoms while on Otezla. Patients, caregivers, and families should
be advised of the need to be alert for the emergence or worsening
of depression, suicidal thoughts, or other mood changes, and they
should contact their healthcare provider if such changes occur
-
- Psoriasis: Treatment with Otezla is associated with an increase
in depression. During clinical trials, 1.3% (12/920) of patients
reported depression compared to 0.4% (2/506) on placebo. Depression
was reported as serious in 0.1% (1/1308) of patients exposed to
Otezla, compared to none in placebo-treated patients (0/506).
Suicidal behavior was observed in 0.1% (1/1308) of patients on
Otezla, compared to 0.2% (1/506) on placebo. One patient treated
with Otezla attempted suicide; one patient on placebo committed
suicide
- Psoriatic Arthritis: Treatment with Otezla is associated with
an increase in depression. During clinical trials, 1.0% (10/998)
reported depression or depressed mood compared to 0.8% (4/495)
treated with placebo. Suicidal ideation and behavior was observed
in 0.2% (3/1441) of patients on Otezla, compared to none in
placebo-treated patients. Depression was reported as serious in
0.2% (3/1441) of patients exposed to Otezla, compared to none in
placebo-treated patients (0/495). Two patients who received placebo
committed suicide compared to none on Otezla
- Behcet's Disease: Treatment with Otezla is associated with an
increase in depression. During the phase 3 clinical trial, 1%
(1/104) reported depression or depressed mood compared to 1%
(1/103) treated with placebo. No instances of suicidal ideation or
behavior were reported in patients treated with Otezla or treated
with placebo
- Weight Decrease: Monitor body weight regularly; evaluate
unexplained or clinically significant weight loss, and consider
discontinuation of Otezla
-
- Psoriasis: During clinical trials, body weight loss of 5-10%
occurred in 12% (96/784) of patients treated with Otezla and in 5%
(19/382) of patients treated with placebo. Body weight loss of ≥10%
occurred in 2% (16/784) of patients treated with Otezla compared to
1% (3/382) of patients treated with placebo
- Psoriatic Arthritis: During clinical trials, body weight loss
of 5-10% was reported in 10% (49/497) of patients taking Otezla and
in 3.3% (16/495) of patients taking placebo
- Behçet's Disease: During the phase 3 clinical trial, body
weight loss of >5% was reported in 4.9% (5/103) of patients
taking Otezla and in 3.9% (4/102) of patients taking placebo
- Drug Interactions: Apremilast exposure was decreased when
Otezla was co-administered with rifampin, a strong CYP450 enzyme inducer; loss of Otezla efficacy
may occur. Concomitant use of Otezla with CYP450 enzyme inducers (e.g., rifampin,
phenobarbital, carbamazepine, phenytoin) is not recommended
Adverse Reactions
- Psoriasis: Adverse reactions reported in ≥5% of patients were
(Otezla%, placebo%): diarrhea (17, 6), nausea (17, 7), upper
respiratory tract infection (9, 6), tension headache (8, 4), and
headache (6, 4)
- Psoriatic Arthritis: Adverse reactions reported in at least 2%
of patients taking Otezla, that occurred at a frequency at least 1%
higher than that observed in patients taking placebo, for up to 16
weeks (after the initial 5-day titration), were (Otezla%,
placebo%): diarrhea (7.7, 1.6); nausea (8.9, 3.1); headache (5.9,
2.2); upper respiratory tract infection (3.9, 1.8); vomiting (3.2,
0.4); nasopharyngitis (2.6, 1.6); upper abdominal pain (2.0,
0.2)
- Behçet's Disease: Adverse reactions reported in at least ≥5% of
patients taking Otezla, that occurred at a frequency at least 1%
higher than that observed in patients taking placebo, for up to 12
weeks, were (Otezla%, placebo%): diarrhea (41.3, 20.4); nausea
(19.2, 10.7); headache (14.4, 10.7); upper respiratory tract
infection (11.5, 4.9); upper abdominal pain (8.7, 1.9); vomiting
(8.7, 1.9); back pain (7.7, 5.8); viral upper respiratory tract
infection (6.7, 4.9); arthralgia (5.8, 2.9)
Use in Specific Populations
- Pregnancy: Otezla has not been studied in pregnant women.
Advise pregnant women of the potential risk of fetal loss. Consider
pregnancy planning and prevention for females of reproductive
potential. There is a pregnancy exposure registry that monitors
pregnancy outcomes in women exposed to Otezla during pregnancy.
Information about the registry can be obtained by calling
1-877-311-8972 or visiting
https://mothertobaby.org/ongoing-study/otezla/
- Lactation: There are no data on the presence of apremilast or
its metabolites in human milk, the effects of apremilast on the
breastfed infant, or the effects of the drug on milk production.
The developmental and health benefits of breastfeeding should be
considered along with the mother's clinical need for Otezla and any
potential adverse effects on the breastfed child from Otezla or
from the underlying maternal condition
- Renal Impairment: Otezla dosage should be reduced in patients
with severe renal impairment (creatinine clearance less than 30
mL/min) for details, see Dosage and Administration, Section 2, in
the Full Prescribing Information
Please click here for Otezla® Full Prescribing
Information.
Amgen Inflammation
Amgen brings therapies to
millions of people with inflammatory diseases, with a focus on
serving unmet patient needs. For those with debilitating moderate
to severe rheumatoid arthritis, psoriatic arthritis, moderate to
severe plaque psoriasis, ankylosing spondylitis, asthma, and other
chronic conditions, the suffering and needs are severe. Complex
diseases of inflammation have defied simple solutions, and the
breadth of inflammatory disease and the burden patients bear is not
well understood.
For more than two decades, Amgen has been committed to
advancing the science and the understanding around inflammation to
address the unmet patient needs that exist and expanding our
portfolio. We lead with science through discovery research that is
disease-agnostic and biology-first, modality-second. In doing so,
we have introduced and evolved novel therapies that have changed
the lives of patients.
Our commitment to patients is reflected not only in where we
have succeeded, but in where we have failed and opened new doors.
Throughout, we have remained dedicated to the principle of leading
with science, pursuing where pathways and promising discoveries in
inflammation take us, and not relenting until innovative solutions
for patients are found. It's a commitment that extends beyond
introducing novel 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.
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.,
Kyowa Kirin Co., Ltd., or any collaboration to manufacture
therapeutic antibodies against COVID-19), the performance of
Otezla® (apremilast) (including anticipated Otezla sales
growth and the timing of non-GAAP EPS accretion), the Five Prime
Therapeutics, Inc. acquisition, 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
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
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may be affected by regulatory, clinical and guideline developments
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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
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
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technology we have acquired, may not be successful. A breakdown,
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confidentiality, integrity and availability of our systems and our
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of events. Global economic conditions may magnify certain risks
that affect our business. 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
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the investigational use(s) discussed in this news release, and no
conclusions can or should be drawn regarding the safety or
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CONTACT: Amgen, Thousand Oaks
Michael Strapazon, 805-313-5553
(Media)
Trish Rowland, 805-447-5631
(media)
Arvind Sood, 805-447-1060
(Investors)
1 National Psoriasis Foundation. About
Psoriasis. Available at: https://www.psoriasis.org/about-psoriasis.
Accessed September 22, 2020.
2 National Psoriasis Foundation. Statistics.
Available at: https://www.psoriasis.org/content/statistics.
Accessed September 22, 2020.
3 Ortonne JP, Prinz JC. Alefacept: a novel and
selective biologic agent for the treatment of chronic plaque
psoriasis. Eur J Dermatol. 2004;14(1):41–45.
4 National Psoriasis Foundation. Plaque Psoriasis.
Available at:
https://www.psoriasis.org/about-psoriasis/types/plaque. Accessed
September 22, 2020.
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