UCB (Euronext:UCB) and Dermira, Inc. (NASDAQ:DERM) today announced
key results from CIMPACT, a Phase 3, multi-center,
placebo-controlled and active-controlled clinical trial evaluating
the efficacy and safety of CIMZIA® (certolizumab pegol) in adult
patients with moderate-to-severe chronic plaque psoriasis. In the
CIMPACT trial, CIMZIA demonstrated statistically significant
improvements for the primary endpoint. CIMPACT is the third and
final Phase 3 clinical trial evaluating CIMZIA in this patient
population.1 Based on the results of the CIMPACT trial,
and those from the previously reported CIMPASI-1 and CIMPASI-2
trials, UCB intends to submit marketing applications to regulatory
authorities in the third quarter of 2017. CIMZIA is not currently
approved for the treatment of psoriasis by any regulatory authority
worldwide.
The primary endpoint in CIMPACT assessed the percentage of
patients on CIMZIA who achieved a 75% or greater disease
improvement from baseline as measured by the Psoriasis Area and
Severity Index (PASI 75), compared with placebo, at week 12.
Several secondary endpoints were assessed, including comparisons of
the efficacy of CIMZIA to ENBREL® based on PASI 75 response rates
at week 12 and comparisons of the response rates of CIMZIA-treated
patients to placebo-treated patients at week 16 using (1) PASI 75
and (2) at least a two-point improvement on a five-point
Physician’s Global Assessment (PGA) scale to a final score
representing clear or almost clear skin. In both the CIMPASI-1 and
CIMPASI-2 trials, PASI 75 and PGA were co-primary endpoints
assessed at week 16.
“We are pleased that the CIMPACT results are consistent with the
efficacy and safety findings observed in two earlier trials
evaluating CIMZIA in patients with moderate-to-severe plaque
psoriasis,” said Tom Wiggans, chief executive officer of Dermira.
“Both companies look forward to submitting these data to regulatory
authorities to support a potential approval of CIMZIA as a
treatment option for moderate-to-severe chronic plaque
psoriasis.”
“The results from CIMPACT support our belief that CIMZIA may one
day be an important treatment option for patients living with
psoriasis. Our psoriasis clinical development program, and our
collaboration with Dermira, aims to provide value to this important
patient population and broaden access to CIMZIA, the only Fc-free,
PEGylated anti-TNF,” said Emmanuel Caeymaex, Head of Immunology and
Executive Vice President, Immunology Patient Value Unit, UCB. “We
look forward to sharing additional data from all three trials at an
upcoming medical congress.”
In all three CIMZIA Phase 3 clinical trials, CIMZIA demonstrated
statistically significant improvements for all primary or
co-primary endpoints compared to placebo at both treatment
doses.
CIMPACT Results
- A total of 559 patients with moderate-to-severe chronic plaque
psoriasis were randomized in the CIMPACT trial to one of four
dosing arms—CIMZIA at 400 mg every two weeks (n=167), CIMZIA at 400
mg at weeks 0, 2, and 4 followed by 200 mg every two weeks (n=165),
ENBREL at 50 mg twice weekly (n=170), or placebo every two weeks
(n=57).
- CIMZIA demonstrated statistically significant improvements in
the primary endpoint. At week 12, the response rate for patients
who achieved a PASI 75 was 66.7% for patients receiving the CIMZIA
400 mg dose every two weeks and 61.3.% for patients receiving the
CIMZIA 200 mg dose every two weeks, compared to 5.0% for patients
receiving placebo.
- The CIMPACT trial also assessed a number of secondary
endpoints, including:-- At week 16, the response rate for patients
who achieved a PASI 75 was 74.7% for patients receiving the 400 mg
dose every two weeks and 68.2% for patients receiving the 200 mg
dose every two weeks, compared to 3.8% for patients receiving
placebo.-- The response rate for patients achieving at least a
two-point improvement to a final score of clear or almost clear
skin on the PGA scale at week 16 was 58.4% for the 400 mg
dose-treated patients and 48.3% for the 200 mg dose-treated
patients, compared to 3.4% for the patients receiving placebo.-- At
week 16, both CIMZIA dosing arms were statistically significant
compared to placebo for the PASI 75 and PGA secondary endpoints.--
At week 12, CIMZIA achieved superiority at the 400 mg dose and
non-inferiority at the 200 mg dose compared to ENBREL.
CIMPASI-1 Results
- A total of 234 patients with moderate-to-severe chronic plaque
psoriasis were randomized in the CIMPASI-1 trial to one of three
dosing arms—400 mg every two weeks (n=88), 400 mg at weeks 0, 2,
and 4 followed by 200 mg every two weeks (n=95), or placebo every
two weeks (n=51).
- At week 16, the response rate for patients who achieved a PASI
75 was 75.8% for patients receiving the 400 mg dose every two weeks
and 66.5% for patients receiving the 200 mg dose every two weeks,
compared to 6.5% for patients receiving placebo.
- The response rate for patients achieving at least a two-point
improvement to a final score of clear or almost clear skin on the
PGA scale at week 16 was 57.9% for the 400 mg dose-treated patients
and 47.0% for the 200 mg dose-treated patients, compared to 4.2%
for the patients receiving placebo.
CIMPASI-2 Results
- A total of 227 patients with moderate-to-severe chronic plaque
psoriasis were randomized to one of three dosing arms—400 mg every
two weeks (n=87), 400 mg at weeks 0, 2, and 4 followed by 200 mg
every two weeks (n=91), or placebo every two weeks (n=49).
- At week 16, the response rate for patients who achieved a PASI
75 was 82.6% for patients receiving the 400 mg dose every two weeks
and 81.4% for patients receiving the 200 mg dose every two weeks,
compared to 11.6% for patients receiving placebo.
- The response rate for patients achieving at least a two-point
improvement to a final score of clear or almost clear skin on the
PGA scale at week 16 was 71.6% for the 400 mg dose-treated patients
and 66.8% for the 200 mg dose-treated patients, compared to 2.0%
for the patients receiving placebo.
The adverse event profile across all three trials appears
consistent with the adverse event profiles observed with CIMZIA in
currently approved indications.1
The data from these trials will be submitted for presentation at
an upcoming medical congress and to a peer-reviewed medical journal
for publication.
As previously communicated, positive results from all three
clinical trials are needed to support regulatory submissions in the
United States (U.S.), Canada and European Union (EU). Based on the
results from CIMPASI-1, CIMPASI-2 and CIMPACT, UCB plans to submit
the data to regulatory authorities in the third quarter of 2017 to
support potential approvals for CIMIZIA as a treatment option for
patients with moderate-to-severe chronic plaque psoriasis.
About CIMZIA Phase 3 Program
The Phase 3 clinical development program, which is led by
Dermira in collaboration with UCB Pharma S.A., is designed to
evaluate the efficacy and safety of CIMZIA in the treatment of
adult patients with moderate-to-severe chronic plaque psoriasis. It
consists of three trials that have enrolled approximately 1,000
patients, including patients with and without prior treatment
experience with biologic products.
Two of the studies, CIMPASI-1 and CIMPASI-2, are randomized,
blinded, parallel group, placebo-controlled, multi-center trials
designed to evaluate the efficacy and safety of CIMZIA in the
treatment of patients with moderate-to-severe chronic plaque
psoriasis. CIMPASI-1 and CIMPASI-2 enrolled 234 and 227 patients,
respectively. A third study, CIMPACT, enrolled 559 patients and is
a randomized, blinded, parallel group, placebo- and
active-controlled, multi-center study designed to evaluate the
efficacy and safety of CIMZIA in patients with moderate-to-severe
chronic plaque psoriasis.
CIMPASI-1 and CIMPASI-2 had co-primary endpoints comprising both
PASI 75 and the percentage of patients achieving at least a
two-point improvement to a final score representing clear or almost
clear skin on a five-point PGA scale, each compared with placebo,
at week 16. The primary endpoint in CIMPACT, the placebo- and
active-controlled study, was the percentage of patients on CIMZIA
achieving a PASI 75 response, compared with placebo, at week 12.
Secondary endpoints of the CIMPACT trial included (1) a comparison
of the efficacy of CIMZIA to ENBREL as measured by PASI 75 response
at week 12 and (2) the percentage of patients who achieved at least
a two-point improvement to a final score representing clear or
almost clear skin on the five-point PGA scale, at week 12. Patients
in each trial may receive blinded CIMZIA treatment for up to 48
weeks followed by an open-label treatment period of up to an
additional 96 weeks.
Under the terms of the agreement announced in July 2014, Dermira
obtained exclusive rights to develop CIMZIA in psoriasis in the
U.S., Canada and the EU. Subject to regulatory approval of CIMZIA
in psoriasis, Dermira is granted an exclusive commercial license to
market CIMZIA to dermatologists in the U.S. and Canada.
CIMZIA® is a registered trademark of the UCB Group of
Companies.
ENBREL® (etanercept) is a registered trademark of Amgen
Inc.
About PsoriasisPsoriasis is a common, chronic,
immune-mediated inflammatory disorder with primary involvement of
the skin. It affects nearly three percent of the world’s
population, or approximately 125 million people worldwide. The skin
condition affects men and women of all ages and ethnicities.
Psoriasis signs and symptoms can vary, but may include red patches
of skin covered with silvery scales, dry, cracked skin that may
bleed and thickened, pitted or ridged nails.2
About Cimzia® In the USCimzia® is the only
Fc-free, PEGylated anti-TNF (Tumor Necrosis Factor). Cimzia® has a
high affinity for human TNF-alpha, selectively neutralizing the
pathophysiological effects of TNF-alpha.
Cimzia® is indicated for the treatment of adults with moderately
to severely active rheumatoid arthritis, adults with active
psoriatic arthritis (PsA), and adults with active ankylosing
spondylitis (AS). In addition, it is indicated for reducing signs
and symptoms of Crohn's disease and maintaining clinical response
in adult patients with moderately to severely active disease who
have had an inadequate response to conventional therapy. See
important safety information including risk of serious bacterial,
viral and fungal infections and tuberculosis below.
Important Safety Information about Cimzia® in the
US
Risk of Serious Infections and Malignancy
Patients treated with Cimzia® are at an increased risk
for developing serious infections that may lead to hospitalization
or death. Most patients who developed these infections were taking
concomitant immunosuppressants such as methotrexate or
corticosteroids. Cimzia® should be discontinued if a patient
develops a serious infection or sepsis. Reported infections
include:
- Active tuberculosis, including reactivation of latent
tuberculosis. Patients with tuberculosis have frequently presented
with disseminated or extrapulmonary disease. Patients should be
tested for latent tuberculosis before Cimzia® use and during
therapy. Treatment for latent infection should be initiated prior
to Cimzia® use.
- Invasive fungal infections, including histoplasmosis,
coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and
pneumocystosis. Patients 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. 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 Cimzia® should
be carefully considered prior to initiating therapy in patients
with chronic or recurrent infection. Patients should be closely
monitored for the development of signs and symptoms of infection
during and after treatment with Cimzia®, including the possible
development of tuberculosis in patients who tested negative for
latent tuberculosis infection prior to initiating
therapy.
Lymphoma and other malignancies, some fatal, have been
reported in children and adolescent patients treated with TNF
blockers, of which Cimzia® is a member. Cimzia® is not indicated
for use in pediatric patients.
Patients treated with Cimzia® are at an increased risk for
developing serious infections involving various organ systems and
sites that may lead to hospitalization or death. Opportunistic
infections due to bacterial, mycobacterial, invasive fungal, viral,
parasitic, or other opportunistic pathogens including
aspergillosis, blastomycosis, candidiasis, coccidioidomycosis,
histoplasmosis, legionellosis, listeriosis, pneumocystosis and
tuberculosis have been reported with TNF blockers. Patients have
frequently presented with disseminated rather than localized
disease.
Treatment with Cimzia® should not be initiated in patients with
an active infection, including clinically important localized
infections. Cimzia® should be discontinued if a patient develops a
serious infection or sepsis. Patients greater than 65 years of age,
patients with co-morbid conditions, and/or patients taking
concomitant immunosuppressants (e.g., corticosteroids or
methotrexate) may be at a greater risk of infection. Patients who
develop a new infection during treatment with Cimzia® should be
closely monitored, undergo a prompt and complete diagnostic workup
appropriate for immunocompromised patients, and appropriate
antimicrobial therapy should be initiated. Appropriate empiric
antifungal therapy should also be considered while a diagnostic
workup is performed for patients who develop a serious systemic
illness and reside or travel in regions where mycoses are
endemic.
Malignancies
During controlled and open-labeled portions of Cimzia® studies
of Crohn’s disease and other diseases, malignancies (excluding
non-melanoma skin cancer) were observed at a rate of 0.5 per 100
patient-years among 4,650 Cimzia®-treated patients versus a rate of
0.6 per 100 patient-years among 1,319 placebo-treated patients. In
studies of Cimzia® for Crohn’s disease and other investigational
uses, there was one case of lymphoma among 2,657 Cimzia®-treated
patients and one case of Hodgkin lymphoma among 1,319
placebo-treated patients. In Cimzia® RA clinical trials
(placebo-controlled and open label), a total of three cases of
lymphoma were observed among 2,367 patients. This is approximately
2-fold higher than expected in the general population. Patients
with RA, particularly those with highly active disease, are at a
higher risk for the development of lymphoma. The potential role of
TNF blocker therapy in the development of malignancies is not
known.
Malignancies, some fatal, have been reported among children,
adolescents, and young adults who received treatment with
TNF-blocking agents (initiation of therapy ≤18 years of age), of
which Cimzia® is a member. Approximately half of the cases were
lymphoma (including Hodgkin’s and non-Hodgkin’s lymphoma), while
the other cases represented a variety of different malignancies and
included rare malignancies associated with immunosuppression and
malignancies not usually observed in children and adolescents. Most
of the patients were receiving concomitant immunosuppressants.
Cases of acute and chronic leukemia have been reported with
TNF-blocker use. Even in the absence of TNF-blocker therapy,
patients with RA may be at a higher risk (approximately 2-fold)
than the general population for developing leukemia.
Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), a
rare type of T-cell lymphoma that has a very aggressive disease
course and is usually fatal, have been reported in patients treated
with TNF blockers, including Cimzia®. The majority of reported TNF
blocker cases occurred in adolescent and young adult males with
Crohn’s disease or ulcerative colitis. Almost all of these patients
had received treatment with the immunosuppressants azathioprine
and/or 6-mercaptopurine (6-MP) concomitantly with a TNF blocker at
or prior to diagnosis. Carefully assess the risks and benefits of
treatment with Cimzia®, especially in these patient types.
Melanoma and Merkel cell carcinoma have been reported in
patients treated with TNF-antagonists, including Cimzia®. Periodic
skin examinations are recommended for all patients, particularly
those with risk factors for skin cancer.
Heart Failure
Cases of worsening congestive heart failure (CHF) and new onset
CHF have been reported with TNF blockers. Cimzia® has not been
formally studied in patients with CHF. Exercise caution when using
Cimzia® in patients who have heart failure and monitor them
carefully.
Hypersensitivity
Symptoms compatible with hypersensitivity reactions, including
angioedema, dyspnea, hypotension, rash, serum sickness, and
urticaria, have been reported rarely following Cimzia®
administration. Some of these reactions occurred after the first
administration of Cimzia®. If such reactions occur, discontinue
further administration of Cimzia® and institute appropriate
therapy.
Hepatitis B Reactivation
Use of TNF blockers, including Cimzia®, has been associated with
reactivation of hepatitis B virus (HBV) in patients who are chronic
carriers of this virus. Some cases have been fatal. Test patients
for HBV infection before initiating treatment with Cimzia®.
Exercise caution in prescribing Cimzia® for patients identified as
carriers of HBV, with careful evaluation and monitoring prior to
and during treatment. In patients who develop HBV reactivation,
discontinue Cimzia® and initiate effective anti-viral therapy with
appropriate supportive treatment.
Neurologic Reactions
Use of TNF blockers, including Cimzia®, has been associated with
rare cases of new onset or exacerbation of clinical symptoms and/or
radiographic evidence of central nervous system demyelinating
disease, including multiple sclerosis, and with peripheral
demyelinating disease, including Guillain-Barré syndrome. Rare
cases of neurological disorders, including seizure disorder, optic
neuritis, and peripheral neuropathy have been reported in patients
treated with Cimzia®. Exercise caution in considering the use of
Cimzia® in patients with these disorders.
Hematologic Reactions
Rare reports of pancytopenia, including aplastic anemia, have
been reported with TNF blockers. Medically significant cytopenia
(e.g., leukopenia, pancytopenia, thrombocytopenia) has been
infrequently reported with Cimzia®. Advise all patients to seek
immediate medical attention if they develop signs and symptoms
suggestive of blood dyscrasias or infection (e.g., persistent
fever, bruising, bleeding, pallor) while on Cimzia®. Consider
discontinuation of Cimzia® therapy in patients with confirmed
significant hematologic abnormalities.
Drug Interactions
An increased risk of serious infections has been seen in
clinical trials of other TNF blocking agents used in combination
with anakinra or abatacept. Formal drug interaction studies have
not been performed with rituximab or natalizumab; however, because
of the nature of the adverse events seen with these combinations
with TNF blocker therapy, similar toxicities may also result from
the use of Cimzia® in these combinations. Therefore, the
combination of Cimzia® with anakinra, abatacept, rituximab, or
natalizumab is not recommended. Interference with certain
coagulation assays has been detected in patients treated with
Cimzia®. There is no evidence that Cimzia® therapy has an effect on
in vivo coagulation. Cimzia® may cause erroneously elevated aPTT
assay results in patients without coagulation abnormalities.
Autoimmunity
Treatment with Cimzia® may result in the formation of
autoantibodies and, rarely, in the development of a lupus-like
syndrome. Discontinue treatment if symptoms of lupus-like syndrome
develop.
Immunizations
Do not administer live vaccines or live-attenuated vaccines
concurrently with Cimzia®.
Adverse Reactions
In controlled Crohn’s clinical trials, the most common adverse
events that occurred in ≥5% of Cimzia® patients (n=620) and more
frequently than with placebo (n=614) were upper respiratory
infection (20% Cimzia®, 13% placebo), urinary tract infection (7%
Cimzia®, 6% placebo), and arthralgia (6% Cimzia®, 4% placebo). The
proportion of patients who discontinued treatment due to adverse
reactions in the controlled clinical studies was 8% for Cimzia® and
7% for placebo.
In controlled RA clinical trials, the most common adverse events
that occurred in ≥3% of patients taking Cimzia® 200 mg every other
week with concomitant methotrexate (n=640) and more frequently than
with placebo with concomitant methotrexate (n=324) were upper
respiratory tract infection (6% Cimzia®, 2% placebo), headache (5%
Cimzia®, 4% placebo), hypertension (5% Cimzia®, 2% placebo),
nasopharyngitis (5% Cimzia®, 1% placebo), back pain (4% Cimzia®, 1%
placebo), pyrexia (3% Cimzia®, 2% placebo), pharyngitis (3%
Cimzia®, 1% placebo), rash (3% Cimzia®, 1% placebo), acute
bronchitis (3% Cimzia®, 1% placebo), fatigue (3% Cimzia®, 2%
placebo). Hypertensive adverse reactions were observed more
frequently in patients receiving Cimzia® than in controls. These
adverse reactions occurred more frequently among patients with a
baseline history of hypertension and among patients receiving
concomitant corticosteroids and non-steroidal anti-inflammatory
drugs. Patients receiving Cimzia® 400 mg as monotherapy every 4
weeks in RA controlled clinical trials had similar adverse
reactions to those patients receiving Cimzia® 200 mg every other
week. The proportion of patients who discontinued treatment due to
adverse reactions in the controlled clinical studies was 5% for
Cimzia® and 2.5% for placebo.
The safety profile for patients with Psoriatic Arthritis (PsA)
treated with CIMZIA® was similar to the safety profile seen in
patients with RA and previous experience with Cimzia®.
The safety profile for AS patients treated with Cimzia® was
similar to the safety profile seen in patients with RA.
For full prescribing information, please visit www.ucb.com
CIMZIA® is a registered trademark of the UCB Group of
Companies.
About Cimzia® in the EU/EEAIn the EU, Cimzia®
in combination with methotrexate (MTX) is indicated for the
treatment of moderate to severe active RA in adult patients
inadequately responsive to disease-modifying anti-rheumatic drugs
(DMARDs) including MTX.
Cimzia® can be given as monotherapy in case of intolerance to
MTX or when continued treatment with MTX is inappropriate. CIMZIA®
in combination with MTX is also indicated for the treatment of
severe, active and progressive RA in adults not previously treated
with MTX or other DMARDs.
Cimzia® has been shown to reduce the rate of progression of
joint damage as measured by X-ray and to improve physical function,
when given in combination with MTX.
Cimzia®, in combination with MTX, is also indicated for the
treatment of active psoriatic arthritis in adults when the response
to previous DMARD therapy has been inadequate. Cimzia® can be given
as monotherapy in case of intolerance to methotrexate or when
continued treatment with methotrexate is inappropriate.
Cimzia® is also indicated in the EU for the treatment of adult
patients with severe active axial spondyloarthritis (axSpA),
comprising:
- Ankylosing spondylitis (AS) - adults with severe active AS who
have had an inadequate response to, or are intolerant to
non-steroidal anti-inflammatory drugs (NSAIDs).
- Axial spondyloarthritis (axSpA) without radiographic evidence
of AS - adults with severe active axSpA without radiographic
evidence of AS but with objective signs of inflammation by elevated
C-reactive protein (CRP) and/or Magnetic Resonance Imaging (MRI)
who have had an inadequate response to, or are intolerant to
NSAIDs.4
Important Safety Information about Cimzia® in the
EU/EEACimzia® was studied in 4,049 patients with
rheumatoid arthritis (RA) in controlled and open label trials for
up to 92 months. The commonly reported adverse reactions (1-10%) in
clinical trials with Cimzia® and post-marketing were viral
infections (includes herpes, papillomavirus, influenza), bacterial
infections (including abscess), rash, headache (including
migraine), asthaenia, leukopaenia (including lymphopaenia,
neutropaenia), eosinophilic disorder, pain (any sites), pyrexia,
sensory abnormalities, hypertension, pruritus (any sites),
hepatitis (including hepatic enzyme increase), injection site
reactions, and nausea. Serious adverse reactions include sepsis,
opportunistic infections, tuberculosis, herpes zoster, lymphoma,
leukaemia, solid organ tumours, angioneurotic oedema,
cardiomyopathies (includes heart failure), ischemic coronary artery
disorders, pancytopaenia, hypercoagulation (including
thrombophlebitis, pulmonary embolism), cerebrovascular accident,
vasculitis, hepatitis/hepatopathy (includes cirrhosis), and renal
impairment/nephropathy (includes nephritis). In RA controlled
clinical trials, 4.4% of patients discontinued taking Cimzia® due
to adverse events vs. 2.7% for placebo.
Cimzia® is contraindicated in patients with hypersensitivity to
the active substance or any of the excipients, active tuberculosis
or other severe infections such as sepsis or opportunistic
infections or moderate-to-severe heart failure.
Serious infections including sepsis, tuberculosis and
opportunistic infections have been reported in patients receiving
Cimzia®. Some of these events have been fatal. Monitor patients
closely for signs and symptoms of infections including tuberculosis
before, during and after treatment with Cimzia®. Treatment with
Cimzia® must not be initiated in patients with a clinically
important active infection. If an infection develops, monitor
carefully and stop Cimzia® if infection becomes serious. Before
initiation of therapy with Cimzia®, all patients must be evaluated
for both active and inactive (latent) tuberculosis infection. If
active tuberculosis is diagnosed prior to or during treatment,
Cimzia® therapy must not be initiated and must be discontinued. If
latent tuberculosis is diagnosed, appropriate anti-tuberculosis
therapy must be started before initiating treatment with Cimzia®.
Patients should be instructed to seek medical advice if
signs/symptoms (e.g. persistent cough, wasting/weight loss, low
grade fever, listlessness) suggestive of tuberculosis occur during
or after therapy with Cimzia®.
Reactivation of hepatitis B has occurred in patients receiving a
TNF-antagonist including Cimzia® who are chronic carriers of the
virus (i.e. surface antigen positive). Some cases have had a fatal
outcome. Patients should be tested for HBV infection before
initiating treatment with Cimzia®. Carriers of HBV who require
treatment with Cimzia® should be closely monitored and in the case
of HBV reactivation Cimzia® should be stopped and effective
anti-viral therapy with appropriate supportive treatment should be
initiated.
TNF antagonists including Cimzia® may increase the risk of new
onset or exacerbation of clinical symptoms and/or radiographic
evidence of demyelinating disease; of formation of autoantibodies
and uncommonly of the development of a lupus-like syndrome; of
severe hypersensitivity reactions. If a patient develops any of
these adverse reactions, Cimzia® should be discontinued and
appropriate therapy instituted.
With the current knowledge, a possible risk for the development
of lymphomas, leukaemia or other malignancies in patients treated
with a TNF antagonist cannot be excluded. Rare cases of
neurological disorders, including seizure disorder, neuritis and
peripheral neuropathy, have been reported in patients treated with
Cimzia®.
Adverse reactions of the hematologic system, including medically
significant cytopaenia, have been infrequently reported with
Cimzia®. Advise all patients to seek immediate medical attention if
they develop signs and symptoms suggestive of blood dyscrasias or
infection (e.g., persistent fever, bruising, bleeding, pallor)
while on Cimzia®. Consider discontinuation of Cimzia® therapy in
patients with confirmed significant haematological
abnormalities.
The use of Cimzia® in combination with anakinra or abatacept is
not recommended due to a potential increased risk of serious
infections. As no data are available, Cimzia® should not be
administered concurrently with live vaccines. The 14-day half-life
of Cimzia® should be taken into consideration if a surgical
procedure is planned. A patient who requires surgery while on
CIMZIA® should be closely monitored for infections.
Cimzia® was studied in 325 patients with active axial
spondyloarthritis (axSpA) in a placebo-controlled clinical trial
for up to 30 months and in 409 patients with psoriatic
arthritis (PsA) in a placebo-controlled clinical trial for up to
30 months. The safety profile for axSpA and PsA patients
treated with Cimzia® was consistent with the safety profile in RA
and previous experience with Cimzia®.
Please consult the full prescribing information in relation to
other side effects, full safety and prescribing information.
European SmPC date of revision 15th December 2016.
http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/001037/WC500069763.pdf
References
- UCB Data on File.
- International Federation of Psoriasis Associations. Accessed
July 14, 2016 at
http://www.worldpsoriasisday.com/web/page.aspx?refid=130
About DermiraDermira is a biopharmaceutical
company dedicated to identifying, developing and commercializing
innovative, differentiated therapies to improve the lives of
patients with dermatologic diseases. Dermira’s portfolio includes
three Phase 3 product candidates that target significant unmet
needs and market opportunities: CIMZIA® (certolizumab pegol), in
development in collaboration with UCB Pharma S.A. for the treatment
of moderate-to-severe chronic plaque psoriasis; DRM04, in
development for the treatment of primary axillary hyperhidrosis
(excessive underarm sweating); and olumacostat glasaretil, in
development for the treatment of acne vulgaris. Dermira is
headquartered in Menlo Park, California. For more information,
please visit www.dermira.com.
In addition to filings with the Securities and Exchange
Commission (SEC), press releases, public conference calls and
webcasts, Dermira uses its website (www.dermira.com) and LinkedIn
page (https://www.linkedin.com/company/dermira-inc-) as channels of
distribution of information about its company, product candidates,
planned financial and other announcements, attendance at upcoming
investor and industry conferences and other matters. Such
information may be deemed material information and Dermira may use
these channels to comply with its disclosure obligations under
Regulation FD. Therefore, investors should monitor Dermira’s
website and LinkedIn page in addition to following its SEC filings,
press releases, public conference calls and webcasts.
About UCBUCB, Brussels, Belgium (www.ucb.com)
is a global biopharmaceutical company focused on the discovery and
development of innovative medicines and solutions to transform the
lives of people living with severe diseases of the immune system or
of the central nervous system. With more than 7 700 people in
approximately 40 countries, the company generated revenue of € 3.9
billion in 2015. UCB is listed on Euronext Brussels (symbol: UCB).
Follow us on Twitter: @UCB_news.
Dermira Forward-Looking Statements The
information in this press release contains forward-looking
statements and information within the meaning of Section 27A of the
Securities Act of 1933, as amended, and Section 21E of the
Securities Exchange Act of 1934, as amended, which are subject to
the “safe harbor” created by those sections. This press release
contains forward-looking statements that involve substantial risks
and uncertainties, including statements with respect to CIMZIA
becoming an important treatment option for, and providing value to,
patients living with psoriasis; the broadening of access to CIMZIA;
anticipated submission of marketing applications to regulatory
authorities in the U.S., Canada and EU to support potential
approvals for CIMIZIA as a treatment option for patients with
moderate-to-severe chronic plaque psoriasis and timing expectations
for such submission; and potential approval of CIMZIA as a
treatment option for moderate-to-severe plaque psoriasis. These
statements deal with future events and involve known and unknown
risks, uncertainties and other factors that may cause actual
results, performance or achievements to be materially different
from the information expressed or implied by these forward-looking
statements. Factors that could cause actual results to differ
materially include risks and uncertainties such as those relating
to the design, implementation and outcomes of Dermira’s clinical
trials; the outcome of future discussions with regulatory
authorities relating to the CIMZIA clinical program; Dermira’s
dependence on third-party clinical research organizations,
manufacturers and suppliers; and Dermira’s ability to continue to
stay in compliance with applicable laws and regulations;. You
should refer to the section entitled “Risk Factors” set forth in
Dermira’s Annual Report on Form 10-K, Dermira’s Quarterly Reports
on Form 10-Q and other filings Dermira makes with
the SEC from time to time for a discussion of important
factors that may cause actual results to differ materially from
those expressed or implied by Dermira’s forward-looking statements.
Furthermore, such forward-looking statements speak only as of the
date of this press release. Dermira undertakes no obligation to
publicly update any forward-looking statements or reasons why
actual results might differ, whether as a result of new
information, future events or otherwise, except as required by
law.
UCB Forward-Looking Statements This press
release contains forward-looking statements based on current plans,
estimates and beliefs of management. All statements, other than
statements of historical fact, are statements that could be deemed
forward-looking statements, including estimates of revenues,
operating margins, capital expenditures, cash, other financial
information, expected legal, political, regulatory or clinical
results and other such estimates and results. By their nature, such
forward-looking statements are not guarantees of future performance
and are subject to risks, uncertainties and assumptions which could
cause actual results to differ materially from those that may be
implied by such forward-looking statements contained in this press
release. Important factors that could result in such differences
include: changes in general economic, business and competitive
conditions, the inability to obtain necessary regulatory approvals
or to obtain them on acceptable terms, costs associated with
research and development, changes in the prospects for products in
the pipeline or under development by UCB, effects of future
judicial decisions or governmental investigations, product
liability claims, challenges to patent protection for products or
product candidates, changes in laws or regulations, exchange rate
fluctuations, changes or uncertainties in tax laws or the
administration of such laws and hiring and retention of its
employees. 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 press 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 existing products will be developed and approved. Products or
potential products which are the subject of partnerships, joint
ventures or licensing collaborations may be subject to differences
between the partners. Also, UCB or others could discover safety,
side effects or manufacturing problems with its products after they
are marketed. Moreover, sales may be impacted by international and
domestic trends toward managed care and health care cost
containment and the reimbursement policies imposed by third-party
payers as well as legislation affecting biopharmaceutical pricing
and reimbursement.
Dermira Contacts:
Media:
Erica Jefferson
Senior Director, Head of Corporate Communications
650-421-7216
erica.jefferson@dermira.com
Investors:
Andrew Guggenhime
Chief Operating Officer and Chief Financial Officer
650-421-7200
investors@dermira.com
Robert H. Uhl
Westwicke Partners
Managing Director
858-356-5932
robert.uhl@westwicke.com
UCB Contacts:
France Nivelle
Global Communications, UCB
T +32.2.559.9178 france.nivelle@ucb.com
Andrea Christopher,
Global Immunology Communications, UCB
T +1.404.483.7329, andrea.levin@ucb.com
Laurent Schots
Media Relations, UCB
T +32.2.559.92.64 Laurent.schots@ucb.com
Antje Witte
Investor Relations, UCB
T +32.2.559.94.14 antje.witte@ucb.com
Isabelle Ghellynck,
Investor Relations, UCB
T +32.2.559.9588, isabelle.ghellynck@ucb.com
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