https://u7061146.ct.sendgrid.net/ls/click?upn=3Du001.gqh-2BaxUzlo7XKIuSly0r=
CyBv9bezcPT-2BuItTLKIHepbxTbo-2FYbVFPSBekB-2Bmk9X7Kl8shoTE6BsSbYYjHYcOVCrOC=
rjYrJUHPDVbu1NKaBE-3D0szJ_2dCLUNbuBjhX746-2FvM63L9Hyn3KnTFGM-2BPPGCjZgmJl-2=
FKl1Z2nt-2BIfez2IJ0TSaz3mplcEW6ZopJ4gUd4Ia3MTdQeFO93DwfIxs8cV3s33SbkEZvEGLN=
n-2B6FohpNoV33-2BWlRP9gZHuN0zxNyx8Fa7M9Le0RGpSKVTD9VAA8lRXBRm-2FGqCNjzFFZaj=
j8EYMA4XO0WMlWqaxWTCc110OcbG0GavzybXxq-2B8DfZHSRmyWZNKbVmbHXNauYogWluZvM7Xk=
hb9WTZJIoQJmrAEJYJDu0FRg6EmRaPPtjpmP2IFuaSm9BrsZomI1LyTuMqQZDaSaHLNvx-2Bi4R=
S7vJuHHoLv0KlcKf3-2BEfOx5C8cCp8LcQ-3D
** Latest real-world evidence presented at WCO-IOF-ESCEO assesses how EVENI=
TY^=C2=AE=E2=96=BC (romosozumab) can help to close the treatment gap in ost=
eoporosi
------------------------------------------------------------
=C2=B7 The first cohort patient study in Denmark for romosozumab highlights=
its use in routine clinical practice.
=C2=B7 Patients within the romosozumab cohort group had a fracture history =
in the past three years which included hip and spine fractures prior to tre=
atment with romosozumab.^1=C2=A0
=C2=B7 The study observations can help to inform optimal clinical use of ro=
mosozumab for postmenopausal women at high risk of fracture.
=E2=96=BC This medicinal product is subject to additional monitoring. This =
will allow quick identification of new safety information. Healthcare profe=
ssionals are asked to report any suspected adverse reactions.
Brussels (Belgium), 12 April 2024 =E2=80=93 UCB, a global biopharmaceutical=
company, today announced key findings from the first retrospective patient=
cohort study in Denmark to observe the characteristics of patients selecte=
d for romosozumab treatment in routine clinical practice. The data were pre=
sented as a poster presentation at the World Congress on Osteoporosis, Oste=
oarthritis and Musculoskeletal Diseases (WCO-IOF-ESCEO) 2024 in London, UK,=
11-14 April.
The observational, retrospective cohort study included female patients aged=
50 years or older receiving osteoporosis medication during September 2020 =
to October 2023, identified by prescription and hospital registry data. Ove=
rall, 149,395 patients were included in the analysis; of these, 622 with a =
fracture in the three years before the date of cohort entry were treated wi=
th romsozumab.^1=C2=A0
The study observed that, of patients who had sustained a fracture at any sk=
eletal site in the three years before the date of cohort entry and were tre=
ated with romosozumab, fracture history included hip fractures (n=3D79/N=3D=
622 (12.7%)) and spine fractures (n=3D64/N=3D622 (10.3%)), in addition to n=
on-hip, non-spine (n=3D303/N=3D622 (48.7%)) and osteoporosis with pathologi=
cal fracture not related to malignancy or other bone diseases (n=3D335/N=3D=
622 (53.9%)). The study also highlighted that of the 622 female patients tr=
eated with romosozumab, 44.5% (n=3D277) had not received any prior treatmen=
t for osteoporosis.^1=C2=A0
=E2=80=9CIt is vital that patients with osteoporosis at high risk of fractu=
re receive timely and appropriate care from the offset to reduce the risk o=
f future fractures and improve outcomes,=E2=80=9D said lead study investiga=
tor Prof Bente Langdahl (Clinical Professor, Aarhus University Hospital, De=
nmark). =E2=80=9CBy offering critical insights into the treatment patterns =
of romosozumab and other osteoporosis treatments in a real-world setting, t=
his study allows us to further investigate prescription patterns and the pr=
ofile of patients who may benefit the most from the use of romosozumab as a=
first-line treatment. This knowledge will help us improve treatment of pat=
ients with severe osteoporosis at high risk of fracture."
The global impact of osteoporosis is profound, with one in three women over=
the age of 50 likely to experience a fracture caused by osteoporosis.^2 In=
Europe alone, the economic cost is estimated at 37.5 billion EUR =E2=80=93=
a number predicted to increase by 27% by 2030.^3 Despite this, data in Eur=
ope has demonstrated that up to 85% of women are not treated for underlying=
osteoporosis following a fragility fracture.^4 =C2=A0
=E2=80=9CThis cohort patient study provides an invaluable blueprint to info=
rm future treatment decision-making and support optimal use of romosozumab =
in clinical practice, both in Denmark and across Europe,=E2=80=9D said Emma=
nuel Caeymaex, Executive Vice President, Immunology and U.S. Solutions at U=
CB. =E2=80=9CThe study findings enable us to understand the use of romosozu=
mab as a treatment option in the real world and demonstrate its potential i=
n closing the treatment gap for patients at high risk of fracture.=E2=80=9D
Romosozumab was approved in the European Union in December 2019 for the tre=
atment of severe osteoporosis in postmenopausal women at high risk of fract=
ure.^5=C2=A0
WCO - World Congress on Osteoporosis, Osteoarthritis and Musculoskeletal Di=
seases; IOF - International Osteoporosis Foundation, ESCEO - European Socie=
ty for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis.
For further information, contact UCB:=C2=A0
Investor Relations
Antje Witte
T +32 2 559 9414
Antje.witte@ucb.com =C2=A0
Global Communications
Adriaan Snauwaert
T+32 497 70 23 46
Adriaan.snauwaert@ucb.com
Date of preparation: April 2024 | GL-RM-2400001
=C2=A9 UCB Biopharma SRL, 2024. All rights reserved.
About the European retrospective cohort study
A retrospective cohort study was conducted using data recorded from Danish =
administrative registries. The study population comprised female patients a=
ged =E2=89=A550 receiving osteoporosis medication during the period from Se=
ptember 2020 to October 2023. The objective of the study is to observe patt=
erns and influencing factors of romosozumab use in routine clinical practic=
e in Denmark. The study included three cohorts: i) patients with severe ost=
eoporosis treated with romosozumab, ii) patients with severe osteoporosis n=
ot treated with romosozumab, and iii) patients who did not have severe oste=
oporosis and were not treated with romosozumab. Patients were considered as=
having severe osteoporosis if they had sustained a fracture at any skeleta=
l site in the three years before the index date (BMD data were not availabl=
e in the dataset). The characteristics investigated in the three cohorts in=
cluded: age, index treatment, comorbidities, osteoporosis treatment history=
, dispensing of drugs that increase risk of falling and fracture, fracture =
history, and use of glucocorticoids.=C2=A0
About EVENITY^=C2=AE (romosozumab)
Romosozumab is a bone-forming monoclonal antibody. It is designed to work b=
y inhibiting the activity of sclerostin, which simultaneously results in in=
creased bone formation and to a lesser extent decreased bone resorption. Th=
e romosozumab development program includes 19 clinical studies that enrolle=
d approximately 14,000 patients. EVENITY has been studied for its potential=
to reduce the risk of fractures in an extensive global phase 3 program tha=
t included two large fracture trials comparing romosozumab to either placeb=
o or active comparator in over 11,000 postmenopausal women with osteoporosi=
s. Amgen and UCB are co-developing romosozumab.
Important Safety Information about EVENITY^=C2=AE (romosozumab) in the EU/E=
EA
In the EU, romosozumab is indicated for treatment of severe osteoporosis in=
postmenopausal women at high risk of fracture.=C2=A0
Contraindications: Romosozumab is contraindicated in patients who are aller=
gic to romosozumab or any of the excipients, who have low levels of calcium=
in the blood (hypocalcaemia), or who have a history of myocardial infarcti=
on (heart attack) or stroke. Myocardial infarction or stroke: Heart attack =
and stroke have been reported in patients receiving romosozumab in randomis=
ed controlled trials (uncommon). Treatment with romosozumab should not be i=
nitiated in patients with a history of heart attack or stroke. When determi=
ning whether to use romosozumab for an individual patient, the presence of =
risk factors for cardiovascular problems, including established cardiovascu=
lar disease, high blood pressure, high blood fat levels, diabetes, smoking =
or kidney problems, should be evaluated. romosozumab should only be used if=
the prescriber and patient agree that the benefit outweighs the risk. If a=
patient experiences a myocardial infarction or stroke during therapy, trea=
tment with romosozumab should be discontinued. Hypocalcaemia: Transient hyp=
ocalcaemia has been observed in patients receiving romosozumab. Hypocalcaem=
ia should be corrected prior to initiating therapy with romosozumab and pat=
ients should be monitored for signs and symptoms of hypocalcaemia. If any p=
atient presents with suspected symptoms of hypocalcaemia during treatment, =
calcium levels should be measured. Patients should be adequately supplement=
ed with calcium and vitamin D. Patients with severe renal impairment (estim=
ated glomerular filtration rate [eGFR] 15 to 29ml/min/1.73m2) or receiving =
dialysis are at greater risk of developing hypocalcaemia and the safety dat=
a for these patients are limited. Calcium levels should be monitored in the=
se patients. Hypersensitivity: Clinically significant hypersensitivity reac=
tions, including angioedema, erythema multiforme, and urticaria occurred in=
the romosozumab group in clinical trials. If an anaphylactic or other clin=
ically significant allergic reaction occurs, appropriate therapy should be =
initiated and use of romosozumab should be discontinued. Osteonecrosis of t=
he Jaw: Osteonecrosis of the jaw (ONJ) has been reported rarely in patients=
receiving romosozumab. The following risk factors should be considered whe=
n evaluating a patient=E2=80=99s risk of developing ONJ: (1) potency of the=
medicinal product that inhibits bone resorption (the risk increases with t=
he antiresorptive potency of the compound), and cumulative dose of bone res=
orption therapy, (2) cancer, co-morbid conditions (e.g. anaemia, coagulopat=
hies, infection), smoking, (3) concomitant therapies: corticosteroids, chem=
otherapy, angiogenesis inhibitors, radiotherapy to head and neck, (4) poor =
oral hygiene, periodontal disease, poorly fitting dentures, history of dent=
al disease, invasive dental procedures e.g. tooth extractions. All patients=
should be encouraged to maintain good oral hygiene and receive routine den=
tal check-ups. Dentures should fit correctly. Patients under dental treatme=
nt, or who will undergo dental surgery (e.g. tooth extractions) whilst bein=
g treated with romosozumab should inform their doctor about their dental tr=
eatment and inform their dentist that they are receiving romosozumab. Patie=
nts should immediately report any oral symptoms such as dental mobility, pa=
in or swelling or non-healing of sores or pus discharge during treatment wi=
th romosozumab. Patients who are suspected of having or who develop ONJ whi=
le receiving romosozumab should receive care by a dentist or an oral surgeo=
n with expertise in ONJ. Discontinuation of romosozumab therapy should be c=
onsidered until the condition resolves and contributing risk factors are mi=
tigated where possible. Atypical Femoral Fractures: Atypical low-energy or =
low trauma fracture of the femoral shaft, which can occur spontaneously, ha=
s been reported rarely in patients receiving romosozumab. Any patient who p=
resents with new or unusual thigh, hip, or groin pain should be suspected o=
f having an atypical fracture and should be evaluated to rule out an incomp=
lete femur fracture. Patient presenting with an atypical femur fracture sho=
uld also be assessed for symptoms and signs of fracture in the contralatera=
l limb. Interruption of romosozumab therapy should be considered, based on =
an individual benefit-risk assessment. Adverse Reactions: The most common a=
dverse reactions were nasopharyngitis (13.6%) and arthralgia (12.4%). Commo=
n adverse reactions included hypersensitivity, sinusitis, rash, dermatitis,=
headache, neck pain, muscle spasms and injection site reactions (most freq=
uent injection site reactions were pain and erythema). Uncommon adverse rea=
ctions were urticaria, hypocalcaemia, stroke, myocardial infarction and cat=
aract. Finally, rare side effects were serious allergic reactions which cau=
sed swelling of the face, throat, hands, feet, ankles or lower legs (angioe=
dema) and acute skin eruption (erythema multiforme).
Refer to the European Summary of Product Characteristics for other adverse =
reactions and full prescribing information. Available at https://u7061146.c=
t.sendgrid.net/ls/click?upn=3Du001.gqh-2BaxUzlo7XKIuSly0rC2tJ60H3Fdk1VajTAI=
Aj7NPJeYj-2Ba-2BL1r-2B0jLM-2FtfvSeD3KLQsazq58-2BxwfyV7LSQXCAZgUBKLrMCFWyh3w=
kMDER6dL987KEnvEiIbPpRtyXKjpJpxWvR2Z4HLzK3wzcZg-3D-3DlYTU_2dCLUNbuBjhX746-2=
FvM63L9Hyn3KnTFGM-2BPPGCjZgmJl-2FKl1Z2nt-2BIfez2IJ0TSaz3mplcEW6ZopJ4gUd4Ia3=
MTdQeFO93DwfIxs8cV3s33SbkEZvEGLNn-2B6FohpNoV33-2BWlRP9gZHuN0zxNyx8Fa7M9Le0R=
GpSKVTD9VAA8lRXBRm-2FGqCNjzFFZajj8EYMA4XO0WMlWqaxWTCc110OcbG71qCFAhd96SR9BT=
q0dgJ8Nh8GtHYFkiYxEhnHk0OuUKR9spZ2c9c4nurZw9ermXw8DXCvRxF-2BgqYbaTuwXHvaMVM=
7-2BkpvWYo-2BRJlSsqhbkR4mo1BKrhMIj1vtqIjtZeUFM4QzZnDZFrPBh-2FB5HU5ME-3D
EVENITY^=C2=AE is a registered trademark of the UCB Group of Companies.=C2=
=A0
About UCB
UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company =
focused on the discovery and development of innovative medicines and soluti=
ons to transform the lives of people living with severe diseases of the imm=
une system or of the central nervous system. With more than 8,000 people op=
erating in more than 40 countries, the company generated revenue of =E2=82=
=AC5.3 billion in 2020. UCB is listed on Euronext Brussels (symbol: UCB). F=
ollow us on Twitter: @UCB_news
About the Amgen and UCB Collaboration
Since 2004, Amgen and UCB have been working together under a collaboration =
and license agreement to research, develop and market antibody products tar=
geting the protein sclerostin. As part of this agreement, the two companies=
continue to collaborate on the development of romosozumab for the treatmen=
t of osteoporosis. This gene-to-drug project demonstrates how Amgen and UCB=
are joining forces to translate a genetic discovery into a new medicine, t=
urning conceptual science into a reality.
Forward looking statements=C2=A0
This press release contains forward-looking statements based on current pla=
ns, estimates and beliefs of management. All statements, other than stateme=
nts of historical fact, are statements that could be deemed forward-looking=
statements, including estimates of revenues, operating margins, capital ex=
penditures, cash, other financial information, expected legal, political, r=
egulatory or clinical results and other such estimates and results. By thei=
r nature, such forward-looking statements are not guarantees of future perf=
ormance and are subject to risks, uncertainties and assumptions which could=
cause actual results to differ materially from those that may be implied b=
y such forward-looking statements contained in this press release. Importan=
t factors that could result in such differences include: changes in general=
economic, business and competitive conditions, the inability to obtain nec=
essary regulatory approvals or to obtain them on acceptable terms, costs as=
sociated with research and development, changes in the prospects for produc=
ts in the pipeline or under development by UCB, effects of future judicial =
decisions or governmental investigations, product liability claims, challen=
ges to patent protection for products or product candidates, changes in law=
s or regulations, exchange rate fluctuations, changes or uncertainties in t=
ax laws or the administration of such laws and hiring and retention of its =
employees.=C2=A0
UCB is providing this information as of the date of this press release and =
expressly disclaims any duty to update any information contained in this pr=
ess release, either to confirm the actual results or to report a change in =
its expectations. There is no guarantee that new product candidates in the =
pipeline will progress to product approval or that new indications for exis=
ting products will be developed and approved. Products or potential product=
s which are the subject of partnerships, joint ventures or licensing collab=
orations may be subject to differences between the partners. Also, UCB or o=
thers could discover safety, side effects or manufacturing problems with it=
s products after they are marketed. Moreover, sales may be impacted by inte=
rnational and domestic trends toward managed care and health care cost cont=
ainment and the reimbursement policies imposed by third-party payers as wel=
l as legislation affecting biopharmaceutical pricing and reimbursement.
References
1. Langdahl B, Lorentzon M, Borgen TT, Alstad C, Bajtner E, Rieem Dun A, Ka=
arill T, Konradsen M, Tsitlakidis E, Moayyeri A. Romosozumab in Denmark =E2=
=80=93 A registry study on osteoporosis patients. Abstract presented at the=
World Congress on Osteoporosis, Osteoarthritis and Musculoskeletal Disease=
s 2024, London (11th =E2=80=93 14th April, 2024).
2. S=C3=B6zen T, =C3=96z=C4=B1=C5=9F=C4=B1k L, Ba=C5=9Faran N=C3=87. An ove=
rview and management of osteoporosis. Eur J Rheumatol. 2017;4(1):46=E2=80=
=9356.
3. IOF. Burden of Osteoporosis. [Online] Available at: https://u7061146.ct.=
sendgrid.net/ls/click?upn=3Du001.gqh-2BaxUzlo7XKIuSly0rCyxclTDEAHMhn9svyzYA=
z3SthNjteviRsQ7P-2BEnN15sg2PaTCRCq-2B6QG24nYIcpgCdKFnR8DIFXVLlmx-2B-2BId5g8=
-3DRlCt_2dCLUNbuBjhX746-2FvM63L9Hyn3KnTFGM-2BPPGCjZgmJl-2FKl1Z2nt-2BIfez2IJ=
0TSaz3mplcEW6ZopJ4gUd4Ia3MTdQeFO93DwfIxs8cV3s33SbkEZvEGLNn-2B6FohpNoV33-2BW=
lRP9gZHuN0zxNyx8Fa7M9Le0RGpSKVTD9VAA8lRXBRm-2FGqCNjzFFZajj8EYMA4XO0WMlWqaxW=
TCc110OcbG8mROYda8-2FfN3HG-2FF8EgMTTLMw1MNnCCcuGDvv0oZTz1aWwCQGdOjBlXPfTtWO=
rXXmBNkpmTH1dzPNFuIRI-2BEp-2FPK3fvncRjC7Gp7Aen5BLE40AnapQRGvaXx55y-2B2YYcSp=
uBamBCK-2FXy7PsdymVwiM-3D (Accessed February 2024).
4. BROKEN BONES, BROKEN LIVES: A roadmap to solve the fragility fracture cr=
isis in Europe. (n.d.). The International Osteoporosis Foundation (IOF), [O=
nline] Available at: https://u7061146.ct.sendgrid.net/ls/click?upn=3Du001.g=
qh-2BaxUzlo7XKIuSly0rCyxclTDEAHMhn9svyzYAz3SxLmZf58KQ8ers8GovkiDuXn09GkjkYf=
SCZ0NTobKhJ9i6hbvsSpZXRuim4180zmzkiNzYP-2FLHf7d63EOjCYfu8JYO7VYfewJfMX4wyQD=
w4MxnqAb31U9FOPXNtKxiIJd-2FQQhIavuJG9ZzFMwi7-2Bx4WdPj_2dCLUNbuBjhX746-2FvM6=
3L9Hyn3KnTFGM-2BPPGCjZgmJl-2FKl1Z2nt-2BIfez2IJ0TSaz3mplcEW6ZopJ4gUd4Ia3MTdQ=
eFO93DwfIxs8cV3s33SbkEZvEGLNn-2B6FohpNoV33-2BWlRP9gZHuN0zxNyx8Fa7M9Le0RGpSK=
VTD9VAA8lRXBRm-2FGqCNjzFFZajj8EYMA4XO0WMlWqaxWTCc110OcbG8-2FrUC7Sz34ZuQp4Cj=
mY-2BBaUNe0ZIadrXAPfVMMQw79-2BamsVEji9gjoNXu03InRi6SbzQYPgjMjLQWfarK1Kkj2EE=
atw5j0CAonfBgezK1bxIjuilUa0vwzIvUqKjGAbDdN1Kyr7SjzzFZUzc7XhVRM-3D (https://=
u7061146.ct.sendgrid.net/ls/click?upn=3Du001.gqh-2BaxUzlo7XKIuSly0rCyxclTDE=
AHMhn9svyzYAz3SxLmZf58KQ8ers8GovkiDuXn09GkjkYfSCZ0NTobKhJ9i6hbvsSpZXRuim418=
0zmyqkOW40FEsYy7QT0OPM-2BrO9BPW_2dCLUNbuBjhX746-2FvM63L9Hyn3KnTFGM-2BPPGCjZ=
gmJl-2FKl1Z2nt-2BIfez2IJ0TSaz3mplcEW6ZopJ4gUd4Ia3MTdQeFO93DwfIxs8cV3s33SbkE=
ZvEGLNn-2B6FohpNoV33-2BWlRP9gZHuN0zxNyx8Fa7M9Le0RGpSKVTD9VAA8lRXBRm-2FGqCNj=
zFFZajj8EYMA4XO0WMlWqaxWTCc110OcbG3lFLcYgcLYR1zuS5sj53khfFQrgiyFdZZ0W8SrKdO=
kowZd55Ez56KQF3oILcS-2Bjq0feWnQ4KuGa3T0w2B257H6OJpflC-2F6-2BtekAIk3KwbkCn-2=
FejlQf37rFPwgNrCZ1C-2B9zeQg6mFDaPZF-2BR08h34SU-3D 2018_EU6_Report_BrokenBon=
esBrokenLives_English.pdf) . (Accessed February 2024).=C2=A0
5. EVENITY^=C2=AE EU SmPC. Available at https://u7061146.ct.sendgrid.net/ls=
/click?upn=3Du001.gqh-2BaxUzlo7XKIuSly0rC2tJ60H3Fdk1VajTAIAj7NPJeYj-2Ba-2BL=
1r-2B0jLM-2FtfvSeD3KLQsazq58-2BxwfyV7LSQXCAZgUBKLrMCFWyh3wkMDER6dL987KEnvEi=
IbPpRtyXKjpJpxWvR2Z4HLzK3wzcZg-3D-3DCJbn_2dCLUNbuBjhX746-2FvM63L9Hyn3KnTFGM=
-2BPPGCjZgmJl-2FKl1Z2nt-2BIfez2IJ0TSaz3mplcEW6ZopJ4gUd4Ia3MTdQeFO93DwfIxs8c=
V3s33SbkEZvEGLNn-2B6FohpNoV33-2BWlRP9gZHuN0zxNyx8Fa7M9Le0RGpSKVTD9VAA8lRXBR=
m-2FGqCNjzFFZajj8EYMA4XO0WMlWqaxWTCc110OcbG2e-2BJymE99VAilZCjkPXMkJFu2cv4D3=
OOzayH25bWdnW-2F8Bq8krtADdu7m9GkbGVEUE0-2FzNzpssEEwotOVSGITrBV2dRqX5OeUnEK5=
tGcLtfcIoqRsHqNTL94i-2BYNg1EuD2jf3evAuZusjN0weHfSvc-3D (Accessed February 2=
024).=C2=A0
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