https://u7061146.ct.sendgrid.net/ls/click?upn=3D4tNED-2FM8iDZJQyQ53jATUb513=
9PTmAm2ORJ-2Fb7C-2B6eni22dDNGFB-2FIreUzrmiICun7MobCJN9eTEeafq3loaxbbNK7ig6C=
MnuKrXTfRhq2y-2FPYTHnkzWaeyRH5RX9qNv8_mX_xDPID0vOuylFAU8fv4e60wei4JxqEGBdVW=
u7KiDwjI3b8sYN46DL86bSl0KxvPs6EFaZqddW-2FBZlGB52Zlf-2FOeoCOG9ekocVj-2F2X9c9=
g1wa997wZWoFMHYW1p3SWRVtkQ0cRgO-2BqdCJqf6hhft0KqmXgWh4iw-2F6GVJCRaIdxQ0EqJL=
-2FknAXeFE-2F9hsXZp1blVV37mt-2FXSvpWJZLgm6VUQxrZQT-2FFOWbdZIjwoycC7Yi4Li4Xm=
m95BG3IIBjobygmqwv3S0WLElTYhMoaRdvjT0xdIaV-2B7ji5yqWkXdE7kt3XvUUBOVYPoxivRC=
HNW3WTUovrqFh2cPVlWqb5WuI95yZv4TF-2BpPn5qVrFzyrE1kU-3D
** UCB and Ferring Pharmaceuticals Announce Co-Promotion of CIMZIA^=C2=AE (=
certolizumab pegol) for the Treatment of Adults with Moderate to Severe Cro=
hn=E2=80=99s Disease
------------------------------------------------------------
=C2=B7 Ferring joins with UCB to promote CIMZIA prefilled syringe for Crohn=
=E2=80=99s disease in the U.S.
=C2=B7 Co-promotion strengthens commitment to patients living with Crohn=E2=
=80=99s disease by reaching more gastroenterologists while also continuing =
patient support programs=C2=A0
=C2=B7 Ferring is expanding its focus in specialty areas within gastroenter=
ology, demonstrating commitment to gut health=C2=A0
=C2=B7 UCB is preparing for future launches in immunology, demonstrating co=
mmitment to patients with severe chronic diseases=C2=A0
Brussels, Belgium and Parsippany, USA =E2=80=93 July 7, 2020 (7:00 p.m. CET=
and 1:00 p.m. ET) =E2=80=93 UCB and Ferring Pharmaceuticals Inc. today ann=
ounced they have entered into a co-promotion agreement to commercialize the=
prefilled syringe formulation of CIMZIA^=C2=AE (certolizumab pegol) in the=
United States, specifically for the treatment of Crohn=E2=80=99s disease (=
CD). Ferring will take over marketing, sales promotion, and field medical a=
ffairs activities. UCB will continue to be responsible for all product-rela=
ted activities, including revenue recognition. CIMZIA is an injectable biol=
ogic treatment option for adults with moderate to severe Crohn=E2=80=99s di=
sease with inadequate response to conventional therapy. UCB will continue t=
o promote and to commercialize the lyophilized formulation of CIMZIA for al=
l indications as well as the prefilled syringe formulation for CIMZIA=E2=80=
=99s rheumatology and dermatology indications.=C2=A0
=E2=80=9CUCB is committed to serving the needs of immunology patients, incl=
uding those living with Crohn=E2=80=99s disease. We are excited about this =
opportunity as it will expand the awareness to the benefits of CIMZIA for i=
ndividuals living with moderate to severe Crohn=E2=80=99s disease, while co=
ntinuing to support patients through our services and programs,=E2=80=9D sa=
id Camille Lee, Head of U.S. Immunology at UCB. =E2=80=9CWe believe UCB and=
Ferring are a strategic fit for the co-promotion as both companies have a =
strong patient-focused commitment and Ferring has expertise in gastroentero=
logy. UCB is preparing for future launches in immunology, demonstrating our=
commitment to patients with severe chronic diseases.=E2=80=9D
This co-promotion allows Ferring to expand its growing portfolio in the gas=
trointestinal space and support patients living with Crohn=E2=80=99s diseas=
e, while enabling UCB to focus on and prepare for the future.=C2=A0
=E2=80=9CFerring is focusing on gut health as we expand our gastroenterolog=
y portfolio,=E2=80=9D said Brent Ragans, President of Ferring US. =E2=80=9C=
Together with our existing portfolio, this agreement with UCB will allow Fe=
rring to offer treatment options to the nearly 800,000 adult patients in th=
e U.S. who suffer from Crohn=E2=80=99s disease.=E2=80=9D
CIMZIA has been a treatment option for adults living with moderate to sever=
e Crohn=E2=80=99s disease over the last 12 years, since it was approved by =
the FDA in 2008 based on safety and efficacy data from clinical trials in m=
ore than 1,500 patients with Crohn's disease.=C2=A0
=C2=A0
CIMZIA can be administered either through self-injection or by a healthcare=
professional.^1 CIMZIA can lower the ability to fight infections. Some peo=
ple who received CIMZIA have developed serious infections, including tuberc=
ulosis (TB) and infections caused by viruses, fungi, or bacteria that have =
spread throughout the body.^1 Some of these serious infections have caused =
hospitalization and death.^1
About Crohn=E2=80=99s disease=C2=A0
Crohn=E2=80=99s disease is an inflammatory bowel disease causing chronic in=
flammation of the gastrointestinal (GI) tract.^2 Crohn=E2=80=99s disease ca=
n affect any part of the GI tract from mouth to anus, most commonly involvi=
ng the ileum and proximal colon.^3 It belongs to a group of conditions know=
n as inflammatory bowel diseases, or IBD.^4 The disease can occur at any ag=
e, but is most often diagnosed in adolescents and adults between the ages o=
f 20 and 30.^2 Approximately 780,000 Americans are currently affected by Cr=
ohn=E2=80=99s disease.^3
Patients with Crohn=E2=80=99s disease may present acutely or have a history=
of symptoms prior to confirming diagnosis.^4 A hallmark symptom in patient=
s with Crohn=E2=80=99s disease is abdominal pain.^4 Other symptoms include =
diarrhea potentially persistent in nature, GI bleeding, urgent need to move=
bowels, abdominal cramps, sensation of incomplete bowel evacuation and con=
stipation, which can lead to bowel obstruction.^4
About CIMZIA^=C2=AE in the US
CIMZIA is the only Fc-free, PEGylated anti-TNF (Tumor Necrosis Factor). CIM=
ZIA has a high affinity for human TNF-alpha, selectively neutralizing the p=
athophysiological effects of TNF-alpha.
CIMZIA is indicated for reducing signs and symptoms of Crohn's disease (CD)=
and maintaining clinical response in adult patients with moderately to sev=
erely active disease who have had an inadequate response to conventional th=
erapy.
CIMZIA is also indicated for the treatment of adults with moderately to sev=
erely active rheumatoid arthritis (RA), adults with active psoriatic arthri=
tis (PsA), adults with active ankylosing spondylitis (AS), and adults with =
active non-radiographic axial spondyloarthritis (nr-axSpA) with objective s=
igns of inflammation.
In addition, CIMZIA is indicated for the treatment of moderate to severe pl=
aque psoriasis (PSO) in adults who are candidates for systemic therapy or p=
hototherapy. See important safety information including risk of serious bac=
terial, viral and fungal infections and tuberculosis below.
IMPORTANT SAFETY INFORMATION about CIMZIA in the U.S.=C2=A0
CONTRAINDICATIONS
CIMZIA is contraindicated in patients with a history of hypersensitivity re=
action to certolizumab pegol or to any of the excipients. Reactions have in=
cluded angioedema, anaphylaxis, serum sickness, and urticaria.
SERIOUS INFECTIONS
Patients treated with CIMZIA are at increased risk for developing serious i=
nfections that may lead to hospitalization or death. Most patients who deve=
loped these infections were taking concomitant immunosuppressants such as m=
ethotrexate or corticosteroids.
Discontinue CIMZIA if a patient develops a serious infection or sepsis.
Reported infections include:
=C2=B7 Active tuberculosis (TB), including reactivation of latent TB. Patie=
nts with TB have frequently presented with disseminated or extrapulmonary d=
isease. Test patients for latent TB before CIMZIA use and during therapy. I=
nitiate treatment for latent TB prior to CIMZIA use.
=C2=B7 Invasive fungal infections, including histoplasmosis, coccidioidomyc=
osis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patien=
ts with histoplasmosis or other invasive fungal infections may present with=
disseminated, rather than localized, disease. Antigen and antibody testing=
for histoplasmosis may be negative in some patients with active infection.=
Consider empiric anti-fungal therapy in patients at risk for invasive fung=
al infections who develop severe systemic illness.
=C2=B7 Bacterial, viral, and other infections due to opportunistic pathogen=
s, including Legionella and Listeria.
Carefully consider the risks and benefits of treatment with CIMZIA prior to=
initiating therapy in the following patients: with chronic or recurrent in=
fection; =C2=A0who have been exposed to TB; =C2=A0with a history of opportu=
nistic infection; who resided in or traveled in regions where mycoses are e=
ndemic; with underlying conditions that may predispose them to infection. M=
onitor patients closely for the development of signs and symptoms of infect=
ion during and after treatment with CIMZIA, including the possible developm=
ent of TB in patients who tested negative for latent TB infection prior to =
initiating therapy.
=C2=B7 Do not start CIMZIA during an active infection, including localized =
infections.
=C2=B7 Patients older than 65 years, patients with co-morbid conditions, an=
d/or patients taking concomitant immunosuppressants may be at greater risk =
of infection.
=C2=B7 If an infection develops, monitor carefully and initiate appropriate=
therapy.
MALIGNANCY
Lymphoma and other malignancies, some fatal, have been reported in children=
and adolescent patients treated with TNF blockers, of which CIMZIA is a me=
mber. CIMZIA is not indicated for use in pediatric patients.
=C2=B7 Consider the risks and benefits of CIMZIA treatment prior to initiat=
ing or continuing therapy in a patient with known malignancy.
=C2=B7 In clinical trials, more cases of malignancies were observed among C=
IMZIA-treated patients compared to control patients.
=C2=B7 In CIMZIA clinical trials, there was an approximately 2-fold higher =
rate of lymphoma than expected in the general U.S. population. Patients wit=
h rheumatoid arthritis, particularly those with highly active disease, are =
at a higher risk of lymphoma than the general population.
=C2=B7 Malignancies, some fatal, have been reported among children, adolesc=
ents, and young adults being treated with TNF blockers. =C2=A0Approximately=
half of the cases were lymphoma, while the rest were other types of malign=
ancies, including rare types associated with immunosuppression and malignan=
cies not usually seen in this patient population.
=C2=B7 Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare=
type of T-cell lymphoma, have been reported in patients treated with TNF b=
lockers, including CIMZIA. These cases have had a very aggressive disease c=
ourse and have been fatal. The majority of reported TNF blocker cases have =
occurred in patients with Crohn=E2=80=99s disease or ulcerative colitis, an=
d the majority were in adolescent and young adult males. =C2=A0Almost all o=
f these patients had received treatment with azathioprine or 6-mercaptopuri=
ne concomitantly with a TNF blocker at or prior to diagnosis. Carefully ass=
ess the risks and benefits of treating with CIMZIA in these patient types.
=C2=B7 Cases of acute and chronic leukemia were reported with TNF blocker u=
se.
HEART FAILURE
=C2=B7 Worsening and new onset congestive heart failure (CHF) has been repo=
rted with TNF blockers. Exercise caution and monitor carefully.
HYPERSENSITIVITY
=C2=B7 Angioedema, anaphylaxis, dyspnea, hypotension, rash, serum sickness,=
and urticaria have been reported following CIMZIA administration. If a ser=
ious allergic reaction occurs, stop CIMZIA and institute appropriate therap=
y. =C2=A0The needle shield inside the removable cap of the CIMZIA prefilled=
syringe contains a plastic derivative of natural rubber latex which may ca=
use an allergic reaction in individuals sensitive to latex.
HEPATITIS B VIRUS REACTIVATION
=C2=B7 Use of TNF blockers, including CIMZIA, may increase the risk of reac=
tivation of hepatitis B virus (HBV) in patients who are chronic carriers. S=
ome cases have been fatal.
=C2=B7 Test patients for HBV infection before initiating treatment with CIM=
ZIA.
=C2=B7 Exercise caution in patients who are carriers of HBV and monitor the=
m before and during CIMZIA treatment.
=C2=B7 Discontinue CIMZIA and begin antiviral therapy in patients who devel=
op HBV reactivation. Exercise caution when resuming CIMZIA after HBV treatm=
ent.
NEUROLOGIC REACTIONS
=C2=B7 TNF blockers, including CIMZIA, have been associated with rare cases=
of new onset or exacerbation of central nervous system and peripheral demy=
elinating diseases, including multiple sclerosis, seizure disorder, optic n=
euritis, peripheral neuropathy, and Guillain-Barr=C3=A9 syndrome.
HEMATOLOGIC REACTIONS
=C2=B7 Rare reports of pancytopenia, including aplastic anemia, have been r=
eported with TNF blockers. Medically significant cytopenia has been infrequ=
ently reported with CIMZIA.
=C2=B7 Consider stopping CIMZIA if significant hematologic abnormalities oc=
cur.
DRUG INTERACTIONS
=C2=B7 Do not use CIMZIA in combination with other biological DMARDS.
AUTOIMMUNITY
=C2=B7 Treatment with CIMZIA may result in the formation of autoantibodies =
and, rarely, in development of a lupus-like syndrome. Discontinue treatment=
if symptoms of a lupus-like syndrome develop.
IMMUNIZATIONS
=C2=B7 Patients on CIMZIA should not receive live or live-attenuated vaccin=
es.
ADVERSE REACTIONS
=C2=B7 The most common adverse reactions in CIMZIA clinical trials (=E2=89=
=A58%) were: upper respiratory infections (18%), rash (9%), and urinary tra=
ct infections (8%).
For full prescribing information, please visit
https://u7061146.ct.sendgrid.net/ls/click?upn=3D4tNED-2FM8iDZJQyQ53jATUZCWF=
NIcc6axu1cq618NlczoNzixzR4-2FzA1T2OMu60OC8eKciWMV5vSACQevcg9ducyMl-2BW1vR03=
EscsBmd8gvM-3DiyMF_xDPID0vOuylFAU8fv4e60wei4JxqEGBdVWu7KiDwjI3b8sYN46DL86bS=
l0KxvPs6EFaZqddW-2FBZlGB52Zlf-2FOeoCOG9ekocVj-2F2X9c9g1wa997wZWoFMHYW1p3SWR=
VtkQ0cRgO-2BqdCJqf6hhft0KqmXgWh4iw-2F6GVJCRaIdxQ0EqJL-2FknAXeFE-2F9hsXZp1bl=
VV37mt-2FXSvpWJZLgm6VUQ75xo3b4I-2FkEQUzkNtpxR-2FRTi3-2FZV5YdODu6DOtc2ys6tBM=
ECYcuAr-2BbuhtTxdjGY-2BxiUt1PydeOh33uGBAmY5Ud4CScaLsA2YYe7tWb0GFkLrLA0j9Sni=
rymWa5kS2c8YkQzzOuOGyo506hqb4OmQM-3D
References:=C2=A0
1. CIMZIA^=C2=AE (certolizumab pegol) [package insert]. Smyrna, GA: UCB, In=
c.=C2=A0
2. Crohn=E2=80=99s & Colitis Foundation. Living with Crohn=E2=80=99s Diseas=
e. Available at: https://u7061146.ct.sendgrid.net/ls/click?upn=3D4tNED-2FM8=
iDZJQyQ53jATUTn0z41-2FoGIT7scX-2FtWm9-2FYSvthmFzIfg-2BcugiHNtSUtAwmAXh0y8Hj=
QEIZ8eU-2Bh-2BuQAkgb-2FE2hYYXES0SrIR67S0vFfRQySk7H4Etp4BeLHIvVxUY1TkskNd8ZQ=
c0X4To9NN-2B1ljjiZ-2FHW-2F679Su1w-3DBeBR_xDPID0vOuylFAU8fv4e60wei4JxqEGBdVW=
u7KiDwjI3b8sYN46DL86bSl0KxvPs6EFaZqddW-2FBZlGB52Zlf-2FOeoCOG9ekocVj-2F2X9c9=
g1wa997wZWoFMHYW1p3SWRVtkQ0cRgO-2BqdCJqf6hhft0KqmXgWh4iw-2F6GVJCRaIdxQ0EqJL=
-2FknAXeFE-2F9hsXZp1blVV37mt-2FXSvpWJZLgm6VUQ4fKJ32DjSRhzronPZmw8K-2FN84y9K=
hxa2pZ9gGg3thjwIZbe-2FRPKlyexo6XNprKhlYuQvOo4NuWxAR4e-2FqDUsQb3sleAPdRy1VuN=
sgMaUQCjtwrX8EtMG2xoCD34d4yWt-2FMTn-2BlpKuJmlIZGCDKI8E0-3D Last accessed: J=
une 2020.
3. Crohn=E2=80=99s & Colitis Foundation. The Facts About Inflammatory Bowel=
Diseases. November 2014. Available at: https://u7061146.ct.sendgrid.net/ls=
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2BcugiHNtSUtAwmAXh0y8HjQEIZ8eU-2Bh-2Bngy5zTjjtykxEwnm530xPK9U-2FGWWZq2I9rhC=
2AF-2BZDB0IAr7zsdqvxG8HSzk7uvbw-3D-3DkXDv_xDPID0vOuylFAU8fv4e60wei4JxqEGBdV=
Wu7KiDwjI3b8sYN46DL86bSl0KxvPs6EFaZqddW-2FBZlGB52Zlf-2FOeoCOG9ekocVj-2F2X9c=
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L-2FknAXeFE-2F9hsXZp1blVV37mt-2FXSvpWJZLgm6VUQ706NxYgbaxu8GYK55DDldgomlpep5=
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June 2020.
# # #
CIMZIA^=C2=AE is a registered trademark of the UCB Group of Companies.
For further information, Ferring Pharmaceuticals:
Heather Guzzi =C2=A0=C2=A0 =C2=A0
Director, Brand Communications=C2=A0
(862) 286-5254 (direct)
(973) 769-3999 (mobile)
heather.guzzi@ferring.com
For further information, UCB:
Corporate Communications
Laurent Schots=C2=A0
Media Relations, UCB =C2=A0
T+32.2.559.92.64 =C2=A0Laurent.schots@ucb.com=C2=A0
Investor Relations
Antje Witte =C2=A0 =C2=A0 =C2=A0 =C2=A0 =C2=A0
Investor Relations, UCB
T +32.2.559.94.14, antje.witte@ucb.com=C2=A0
=C2=A0
Isabelle Ghellynck
Investor Relations, UCB
T+32.2.559.9588, isabelle.ghellynck@ucb.com=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 7 600 people in=
approximately 40 countries, the company generated revenue of =E2=82=AC 4.9=
billion in 2019. UCB is listed on Euronext Brussels (symbol: UCB). Follow =
us on Twitter: @UCB_news
About Ferring Pharmaceuticals
Ferring Pharmaceuticals is a research-driven, specialty biopharmaceutical g=
roup committed to helping people around the world build families and live b=
etter lives. In the United States, Ferring is a leader in reproductive medi=
cine and maternal health, and in specialty areas within gastroenterology an=
d orthopaedics. For more information, call 1-888-FERRING (1-888-337-7464); =
visit www.FerringUSA.com
Forward looking statements UCB
This press release may contain forward-looking statements including, withou=
t limitation, statements containing the words =E2=80=9Cbelieves=E2=80=9D, =
=E2=80=9Canticipates=E2=80=9D, =E2=80=9Cexpects=E2=80=9D, =E2=80=9Cintends=
=E2=80=9D, =E2=80=9Cplans=E2=80=9D, =E2=80=9Cseeks=E2=80=9D, =E2=80=9Cestim=
ates=E2=80=9D, =E2=80=9Cmay=E2=80=9D, =E2=80=9Cwill=E2=80=9D, =E2=80=9Ccont=
inue=E2=80=9D and similar expressions. These forward-looking statements are=
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ssful as UCB may have believed at the moment of acquisition. Also, UCB or o=
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ircumstances on which any such statement is based, unless such statement is=
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Additionally, information contained in this document shall not constitute a=
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shall there be any offer, solicitation or sale of securities in any jurisdi=
ction in which such offer, solicitation or sale would be unlawful prior to =
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