- Data presentations including the extended LIBERTY studies to
highlight the long-term treatment goals of
ZYMFENTRA™, the first and only FDA-approved
subcutaneous infliximab
- The data underscores Celltrion's commitment to
improving patient outcomes and advancing scientific understanding
in the field of IBD
JERSEY
CITY, N.J., May 17, 2024
/PRNewswire/ -- Celltrion USA
today announced it will present the two-year results from the
extended LIBERTY studies (LIBERTY-CD and LIBERTY-UC) in adult
patients with moderately to severely active Crohn's disease (CD)
and ulcerative colitis (UC) receiving maintenance treatment after
infliximab IV (intravenous) induction. The data will be shared
during the Digestive Disease Week® (DDW) 2024 Annual
Meeting in Washington, D.C., from
May 18 to 21.
"We are pleased to participate in this year's DDW and share our
latest findings, including results from the two-year extension
phase LIBERTY studies, alongside post-hoc analysis of the
LIBERTY-CD study," said Nam Lee,
Medical Director at Celltrion. "Following the U.S. launch of the
first and only FDA-approved subcutaneous infliximab, ZYMFENTRA, we
are thrilled to continue to share data showcasing our strong
commitment to the IBD community."
The clinical data from the extended LIBERTY studies and post-hoc
analysis of the LIBERTY-CD study will be presented during 18 oral
and poster presentations.
The details of Celltrion USA's
abstract presentations are as follows:
Poster Presentations:
- Subcutaneous infliximab (CT-P13 SC) as maintenance therapy
for Crohn's disease: 2-year results of the LIBERTY-CD study (Poster
#Su1762)
- Subcutaneous infliximab (CT-P13 SC) for ulcerative colitis:
2-year extension results of the LIBERTY-UC study (Poster
#Su1779)
- Impact of immunogenicity on clinical outcomes in patients with
Crohn's disease receiving maintenance treatment with subcutaneous
infliximab: A post-hoc analysis of the LIBERTY-CD Study (Poster
#Su1765)
- Impact of body mass index on clinical outcomes and drug levels
in patients with Crohn's disease receiving maintenance
treatment with subcutaneous infliximab: A post-hoc analysis of the
LIBERTY-CD study (Poster #Su1755)
- Super-responders in patients with
moderate-to-severe Crohn's disease treated with subcutaneous
infliximab maintenance therapy: A post-hoc analysis of the
LIBERTY-CD study (Poster #Su1767)
- Network meta-analysis to evaluate the comparative efficacy of
advanced therapies as first line for maintenance treatment of adult
patients with moderate-to-severe Crohn's disease (Poster
#Mo1175)
- Effectiveness of switching from intravenous to subcutaneous
infliximab in inflammatory bowel disease patients: A combined
analysis of real-world evidence (Poster #Mo1854)
- Subcutaneous infliximab effectively manages clinical outcomes
of inflammatory bowel disease independently of various confounding
factors (Poster #Mo1869)
- Clinical efficacy and durability of subcutaneous infliximab in
patients with inflammatory bowel disease after switching from
intravenous infliximab (Poster #Mo1837)
- A prospective evaluation of clinical outcomes of
subcutaneous infliximab following intravenous induction
therapy in patients with Crohn's disease (Poster #Su1823)
- One-year clinical outcomes of switching to subcutaneous
infliximab in patients with inflammatory bowel disease on
maintenance of intravenous infliximab therapy with or without
remission (Poster #Mo1826)
- Subcutaneous infliximab in Crohn's disease patients with
immunogenic failure of intravenous infliximab (Poster #Mo1843)
- Intravenous to subcutaneous infliximab switch may reduce the
risk of immunogenicity related treatment failure and can be used to
facilitate immunomodulator withdrawal (Poster #Mo1856)
- Clinical efficacy and durability of subcutaneous infliximab in
patients with moderate-to-severe inflammatory bowel disease (Poster
#Mo1838)
- Rapid symptomatic improvement with subcutaneous infliximab
induction treatment for patients with moderate to severe Crohn's
disease (Poster #Sa1760)
- Pharmacokinetics of subcutaneous infliximab induction and
maintenance in moderate-to-severely active Crohn's disease
patients: weight matters (Poster #Su1811)
Oral Presentations
- Persistence, efficacy and tolerance of
subcutaneous infliximab after switch from intravenous
infliximab in IBD patients in remission: One-year results from a
multi-center prospective cohort (Oral Presentation #1179)
- Effectiveness and safety of subcutaneous infliximab in
perianal Crohn's disease: A multicentre cohort study (Oral
Presentation #1176)
About Celltrion USA
Celltrion USA is Celltrion's
U.S. subsidiary established in 2018. Headquartered in New Jersey, Celltrion USA is committed to expanding access to
innovative biologics to improve care for U.S. patients. Celltrion
currently has five biosimilars approved by the U.S. FDA:
INFLECTRA® (infliximab-dyyb),
TRUXIMA® (rituximab-abbs),
HERZUMA® (trastuzumab-pkrb),
VEGZELMA® (bevacizumab-adcd) and
YUFLYMA®(adalimumab-aaty) as well as a new biologic
ZYMFENTRA™. Celltrion USA will
continue to leverage Celltrion's unique heritage in biotechnology,
supply chain excellence and best-in-class sales capabilities to
improve access to high-quality biopharmaceuticals for U.S.
patients. For more information, please visit:
www.celltrionusa.com.
About Digestive Disease Week ®
Digestive Disease Week® (DDW) is the largest
international gathering of physicians, researchers and academics in
the fields of gastroenterology, hepatology, endoscopy and
gastrointestinal surgery. Jointly sponsored by the American
Association for the Study of Liver Diseases (AASLD), the American
Gastroenterological Association (AGA), the American Society for
Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of
the Alimentary Tract (SSAT), DDW is an in-person and online meeting
from May 18-21, 2024. The meeting
showcases more than 4,400 abstracts and hundreds of lectures on the
latest advances in GI research, medicine and technology. More
information can be found at www.ddw.org
About ZYMFENTRA™ (infliximab-dyyb)
ZYMFENTRA is a prescription medicine used as an injection under
the skin (subcutaneous injection) by adults for the maintenance
treatment of: Moderately to severely active ulcerative colitis
following treatment with an infliximab product given by intravenous
infusion (IV) and moderately to severely active Crohn's disease
following treatment with an infliximab product given by intravenous
infusion (IV). ZYMFENTRA blocks the action of tumor necrosis
factor-alpha (TNF-alpha), a protein that can be overproduced in
response to certain diseases and cause the immune system to attack
normal, healthy parts of the body.
ZYMFENTRA (infliximab-dyyb) was approved by the FDA through the
Biologics License Application (BLA) under the 351 (a) pathway of
the Public Health Service Act (a "stand-alone" BLA). ZYMFENTRA is a
self-injected form of infliximab and thus will be under patent
protection for its dosage form by 2037 and for its route of
administration by 2040.
ZYMFENTRA™ (infliximab-dyyb) U.S. Use and
Important Safety Information
ZYMFENTRA is a prescription medicine indicated in adults for
maintenance treatment of:
- Moderately to severely active Crohn's disease
following treatment with an infliximab product administered
intravenously.
- Moderately to severely active ulcerative
colitis following treatment with an infliximab product
administered intravenously.
It is not known if ZYMFENTRA is safe and effective in
children under 18 years of age.
What is the most important information I should know about
ZYMFENTRA?
SERIOUS INFECTIONS
Patients treated with ZYMFENTRA
are at increased risk for developing serious infections involving
various organ systems and sites that may lead to hospitalization or
death. Discontinue ZYMFENTRA if a patient develops a serious
infection or sepsis.
Reported infections include:
- Active tuberculosis (TB), including reactivation of latent
TB. Patients frequently presented with disseminated
or extrapulmonary disease. Patients should be tested for
latent TB before and during treatment with ZYMFENTRA. Treatment for
latent infection should be initiated prior to treatment with
ZYMFENTRA.
- Invasive fungal infections, including histoplasmosis,
coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and
pneumocystosis. Patients may present with disseminated, rather than
localized, disease. Empiric anti-fungal therapy should be
considered in patients at risk for invasive fungal infections who
develop severe systemic illness.
- Bacterial, viral, and other infections due to opportunistic
pathogens, including Legionella and Listeria.
The risks and benefits of treatment with ZYMFENTRA should be
carefully considered prior to initiating therapy in patients with
chronic or recurrent infection. Closely monitor patients for the
development of signs and symptoms of infection during and after
treatment with ZYMFENTRA, including the possible development of TB
in patients who tested negative for latent TB infection prior to
initiating therapy.
Risk of infection may be higher in patients greater than 65
years of age, patients with comorbid conditions and/or patients
taking concomitant immunosuppressant therapy. In clinical trials,
other serious infections observed in patients treated with
infliximab included arthritis bacterial, pneumonia, and urinary
tract infection.
MALIGNANCIES
Malignancies, some fatal, have been
reported in children, adolescents, and young adults treated with
TNF blockers, including infliximab products.
Approximately
half of these cases were lymphomas, including Hodgkin's and
non-Hodgkin's lymphoma. The other cases represented a variety of
malignancies, including rare malignancies that are usually
associated with immunosuppression and malignancies that are not
usually observed in children and adolescents. The malignancies
occurred after a median of 30 months after the first dose of
therapy. Most of the patients were receiving concomitant
immunosuppressants.
Post-marketing cases of hepatosplenic T-cell lymphoma, a rare
type of T-cell lymphoma, have been reported in patients treated
with TNF blockers, including infliximab products. These cases have
had a very aggressive disease course and have been fatal. The
majority of reported cases have occurred in patients with Crohn's
disease or ulcerative colitis, and most were in adolescent and
young adult males. Almost all of these patients had received
treatment with azathioprine or 6-mercaptopurine concomitantly with
a TNF blocker at or prior to diagnosis. Carefully assess the risks
and benefits of treatment with ZYMFENTRA, especially in these
patient types.
In clinical trials of all TNF blockers, more cases of
malignancies were observed compared with controls and the expected
rate in the general population. In clinical trials of some TNF
blockers, including infliximab products, more cases of other
malignancies were observed compared with controls. As the potential
role of TNF blocker therapy in the development of malignancies is
not known, caution should be exercised when considering treatment
of patients with a current or a past history of malignancy.
Melanoma and Merkel cell carcinoma have been reported in
patients treated with TNF blocker therapy, including infliximab
products. Periodic skin examination is recommended for all
patients, particularly those with risk factors for skin cancer.
CONTRAINDICATIONS
ZYMFENTRA is contraindicated in
patients with a previous severe hypersensitivity reaction to
infliximab-dyyb, other infliximab products, any of the inactive
ingredients of ZYMFENTRA or any murine proteins (severe
hypersensitivity reactions have included anaphylaxis, hypotension,
and serum sickness).
HEPATITIS B VIRUS REACTIVATION
TNF blockers, including
infliximab products, have been associated with reactivation of
hepatitis B virus (HBV) in patients who are chronic carriers. Some
cases were fatal. Patients should be tested for HBV infection
before initiating ZYMFENTRA. For patients who test positive,
consult a physician with expertise in the treatment of hepatitis B.
Exercise caution when prescribing ZYMFENTRA for patients identified
as carriers of HBV, and monitor closely for active HBV infection
during and following termination of therapy with ZYMFENTRA.
Discontinue ZYMFENTRA in patients who develop HBV reactivation and
initiate antiviral therapy with appropriate supportive treatment.
Exercise caution when considering resumption of ZYMFENTRA, and
monitor patients closely.
HEPATOTOXICITY
Hepatobiliary disorders, including
acute liver failure, jaundice abnormal hepatic function, hepatic
steatosis, hepatitis, hepatotoxicity, hyperbilirubinemia, and
non-alcoholic fatty liver, have been reported in patients receiving
infliximab products post-marketing. Some cases were fatal or
required liver transplant. Aminotransferase elevations were not
noted prior to discovery of liver injury in many cases. Patients
with symptoms or signs of liver dysfunction should be evaluated for
evidence of liver injury. If jaundice and/or marked liver enzyme
elevations (eg, ≥5 times the upper limit of normal) develop,
ZYMFENTRA should be discontinued, and a thorough investigation of
the abnormality should be undertaken.
CONGESTIVE HEART FAILURE
Cases of worsening congestive
heart failure (CHF) and new onset CHF have been reported with TNF
blockers. Some cases had a fatal outcome. In several exploratory
trials of other TNF blockers in the treatment of CHF, there were
greater proportions of TNF-blocker-treated patients who had CHF
exacerbations requiring hospitalization or increased mortality.
ZYMFENTRA has not been studied in patients with a history of CHF
and ZYMFENTRA should be used with caution in patients with CHF.
HEMATOLOGIC REACTION
Cases of leukopenia, neutropenia,
thrombocytopenia, and pancytopenia (some fatal) have been reported.
The causal relationship to infliximab-product therapy remains
unclear. Exercise caution in patients who have ongoing or a history
of significant hematologic abnormalities. Advise patients to seek
immediate medical attention if they develop signs and symptoms of
blood dyscrasias or infection. Consider discontinuation of
ZYMFENTRA in patients who develop significant hematologic
abnormalities.
HYPERSENSITIVITY AND OTHER ADMINISTRATION REACTIONS
In
post-marketing experience, serious systemic hypersensitivity
reactions (including anaphylaxis, hypotension, and serum sickness)
have been reported following administration of infliximab products.
If an anaphylactic or other clinically significant hypersensitivity
reaction occurs, institute appropriate therapy and discontinue
ZYMFENTRA.
INJECTION SITE REACTIONS
In clinical studies,
localized injection-site reactions were reported following
administration of ZYMFENTRA. If a clinically significant
injection-site reaction occurs, institute appropriate therapy and
discontinue ZYMFENTRA.
NEUROLOGIC REACTIONS
Agents that inhibit TNF have been
associated with central nervous system (CNS) manifestation of
systemic vasculitis, seizure, and new onset or exacerbation of CNS
demyelinating disorders, including multiple sclerosis and optic
neuritis, and peripheral demyelinating disorders, including
Guillain-Barré syndrome. Exercise caution when considering
ZYMFENTRA in patients with these disorders and consider
discontinuation if these disorders develop.
RISK OF INFECTION WITH CONCURRENT ADMINISTRATION OF OTHER
BIOLOGICS PRODUCTS
Serious infections and neutropenia have
been reported with concurrent use of ZYMFENTRA with other
immunosuppressive biological products. The concurrent use of
ZYMFENTRA with other immunosuppressive biological products used to
treat UC and CD may increase the risk of infection and is not
recommended.
RISK OF ADDITIVE IMMUNOSUPPRESSIVE EFFECTS FROM PRIOR
BIOLOGICAL PRODUCTS
Consider the half-life and mode of
action of prior biological products to avoid unintended additive
immunosuppressive effects when initiating ZYMFENTRA.
AUTOIMMUNITY
Treatment with TNF blockers may result in
the formation of autoantibodies and in the development of a
lupus-like syndrome. Discontinue ZYMFENTRA treatment if symptoms of
a lupus-like syndrome develop.
VACCINATIONS AND USE OF LIVE VACCINES/THERAPEUTIC INFECTIOUS
AGENTS
Prior to initiating ZYMFENTRA, update vaccinations in
accordance with current vaccination guidelines. Live vaccines or
therapeutic infectious agents should not be given with ZYMFENTRA
due to the possibility of clinical infections, including
disseminated infections. At least a 6-month waiting period
following birth is recommended before the administration of any
live vaccine to infants exposed in utero to ZYMFENTRA.
ADVERSE REACTIONS
In clinical trials with ZYMFENTRA,
the most common adverse reactions occurring in ≥3% of ZYMFENTRA
-treated patients included site reactions, COVID-19, anemia,
arthralgia, infection site reaction, increased alanine
aminotransferase and abdominal pain for UC, and COVID-19, headache,
upper respiratory tract infection, injection site reaction,
diarrhea, increased blood creatine phosphokinase, arthralgia,
increased alanine aminotransferase, hypertension, urinary tract
infection, neutropenia, dizziness and leukopenia for CD.
Please click for Full U.S. Prescribing Information.
Globally, prescribing information varies; refer to the
individual country product label for complete information.
FORWARD-LOOKING STATEMENT
Certain information set forth in this press release contains
statements related to our future business and financial performance
and future events or developments involving Celltrion that may
constitute forward-looking statements, under pertinent securities
laws.
These statements may be identified by words such as "prepares",
"hopes to", "upcoming", "plans to", "aims to", "to be launched",
"is preparing, "once gained", "could", "with the aim of", "may",
"once identified", "will", "working towards", "is due", "become
available", "has potential to", the negative of these words or such
other variations thereon or comparable terminology.
In addition, our representatives may make oral forward-looking
statements. Such statements are based on the current expectations
and certain assumptions of Celltrion's management, of which many
are beyond its control.
Forward-looking statements are provided to allow potential
investors the opportunity to understand management's beliefs and
opinions with respect to the future so that they may use such
beliefs and opinions as one factor in evaluating an investment.
These statements are not guarantees of future performance and undue
reliance should not be placed on them.
Such forward-looking statements necessarily involve known and
unknown risks and uncertainties, which may cause actual performance
and financial results in future periods to differ materially from
any projections of future performance or results expressed or
implied by such forward-looking statements.
Such Risks and uncertainties may include, among other things,
uncertainties regarding the launch timing and commercial success of
Celltrion in the United States;
the uncertainties inherent in supply chain, manufacturing, research
and development, and the possibility of unfavorable new clinical
data and further analyses of existing clinical data as it relates
to Celltrion products; intellectual property and/or
litigation/settlement implications; decisions by the FDA impacting
labeling, manufacturing processes, safety, promotion, and/or other
matters that could affect the availability or commercial potential
of Celltrion products; and uncertainties regarding access
challenges for our biosimilar products where our product may not
receive appropriate formulary access or remains in a disadvantaged
position relative to competitive products; and competitive
developments. A further description of risks and uncertainties can
be found in Celltrion's Annual Report.
Although forward-looking statements contained in this
presentation are based upon what management of Celltrion believes
are reasonable assumptions, there can be no assurance that
forward-looking statements will prove to be accurate, as actual
results and future events could differ materially from those
anticipated in such statements. Celltrion undertakes no obligation
to update forward-looking statements if circumstances or
management's estimates or opinions should change except as required
by applicable securities laws. The reader is cautioned not to place
undue reliance on forward-looking statements.
Contacts
Sarah
Amundsen
samundsen@apcoworldwide.com
+1 920-946-0918
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