- Phase 3 program aims to address patient need for alternative
treatment options in moderate-to-severe psoriasis
- Program includes the first Phase 3 study in psoriasis comparing
two anti-TNFs
- Based on current enrollment projections, top-line data from
these studies are expected in 2017
Dermira, Inc., a specialty biopharmaceutical company focused on
bringing innovative and differentiated medical dermatology products
to dermatologists and their patients (Nasdaq:DERM), and UCB, a
global biopharmaceutical leader (Euronext:UCB), announced today
that the first patients have been dosed in the Phase 3 clinical
program designed to evaluate the efficacy and safety of CIMZIA®
(certolizumab pegol) in adult patients with moderate-to-severe
chronic plaque psoriasis. This is an important step forward in the
collaboration between Dermira and UCB in the development of
solutions for patients with moderate-to-severe plaque psoriasis, a
severe autoimmune disease.1 CIMZIA® is not currently approved for
the treatment of psoriasis by any regulatory authority
worldwide.
"We are excited to have advanced CIMZIA® into Phase 3 trials in
moderate-to-severe plaque psoriasis with the goal of extending
product access to patients who live with this debilitating skin
disease," stated Tom Wiggans, Chief Executive Officer, Dermira.
"CIMZIA® is approved as a treatment option for patients living with
a range of inflammatory diseases, and we are proud to be working
with UCB with the goal of bringing this important therapeutic
option to the millions of patients with moderate-to-severe
psoriasis."
"CIMZIA® is UCB's lead product, and our collaboration with
Dermira and the Phase 3 psoriasis program demonstrate our continued
commitment to further investigate CIMZIA® in an effort to
potentially broaden patient access and improve outcomes for people
living with this chronic autoimmune disorder," said Professor Dr.
Iris Loew-Friedrich, Chief Medical Officer and Executive Vice
President, UCB.
The Phase 3 clinical development program, which is led by
Dermira in collaboration with UCB, is designed to evaluate the
efficacy and safety of certolizumab pegol in the treatment of adult
patients with moderate-to-severe chronic plaque psoriasis. It
consists of three studies that aim to enroll a total of
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 studies
designed to evaluate the efficacy and safety of certolizumab pegol
in the treatment of patients with moderate-to-severe chronic plaque
psoriasis. The third study, CIMPACT, is a randomized, blinded,
parallel group, placebo-controlled and blinded, active-controlled,
multi-center study with a primary objective of comparing the
efficacy and safety of certolizumab pegol to placebo in the
treatment of patients with moderate-to-severe chronic plaque
psoriasis. A secondary objective of the study is to compare the
efficacy and safety of certolizumab pegol to etanercept (marketed
as ENBREL®).*
The primary endpoint in CIMPACT, the placebo- and
active-controlled study, is the percentage of patients on
certolizumab pegol achieving 75% or greater disease improvement
from baseline, compared with placebo, as measured by the Psoriasis
Area and Severity Index (PASI 75) at week 12. CIMPASI-1 and
CIMPASI-2, the placebo-controlled studies, have 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 Physician's
Global Assessment scale, each compared with placebo, at week 16.
Patients in each trial may receive blinded treatment for up to 48
weeks and, based on current enrollment projections, top-line data
from these studies are expected in 2017. Patients in each study may
receive open-label treatment with certolizumab pegol for up to an
additional 96 weeks.
In a completed, 176-patient Phase 2 study, PASI 75 was achieved
by 75% (44/59), 83% (48/58) and 7% (4/59) of patients in the
certolizumab pegol 200 mg, 400 mg and placebo groups, respectively
(p<0.001 for both treatment arms vs. placebo). These Phase 2
results support the continued Phase 3 clinical program for the
development of certolizumab pegol in psoriasis.2
Under the terms of the agreement announced in July 2014, Dermira
obtained exclusive rights to develop certolizumab pegol in
psoriasis in the United States, Canada and the European Union.
Subject to regulatory approval of CIMZIA® in psoriasis, Dermira is
granted an exclusive commercial license to market CIMZIA® to
dermatologists in the US and Canada. The dosing of the first
patient in the Phase 3 program has triggered a milestone payment of
$7.3 million payable by UCB to Dermira in the first quarter of
2015.
*ENBREL® (etanercept) is a registered trademark of Amgen
Inc.
About Psoriasis1
Psoriasis is a common, chronic, relapsing, immune-mediated,
inflammatory disorder with primary involvement of the skin. It
affects two to three per-cent of the world's population –
approximately 125 million people worldwide. Psoriasis signs and
symptoms can vary from person to person but may include red patches
of skin covered with silvery scales, dry, cracked skin that may
bleed and thickened, pitted or ridged nails.
About CIMZIA®
CIMZIA® 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.
About CIMZIA® in the US3
In the US, CIMZIA® is approved for the treatment of adults with
moderately to severely active rheumatoid arthritis, for the
treatment of adults with active psoriatic arthritis (PsA) and for
adults with active ankylosing spondylitis (AS). In addition, it is
approved 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.
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.
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 a PTT
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
About CIMZIA® in the EU/EEA4
CIMZIA® in combination with methotrexate (MTX) is approved in
the EU for the treatment of moderate-to-severe active RA in adult
patients inadequately responsive to disease-modifying antirheumatic
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 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 approved 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.
Important Safety Information about CIMZIA® in the
EU/EEA
CIMZIA® 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 27th October 2014.
http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/001037/WC500069763.pdf
References
1. International Federation of Psoriasis Associations.
Accessed 27th November 2014 at
http://www.worldpsoriasisday.com/web/page.aspx?refid=130
2. Reich et al. Successful treatment of moderate to severe
plaque psoriasis with the PEGylated Fab' certolizumab pegol:
results of a phase II, randomized, placebo controlled trial with a
re-treatment extension. British Journal of Dermatology 2012,
167: 180-190
3. CIMZIA® US Prescribing Information. Accessed 27th
November 2014 from http://www.ucb.com/
4. CIMZIA® EU Summary of Product Characteristics. Accessed
27th November 2014 from
http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/001037/WC500069763.pdf
About Dermira
Dermira (Nasdaq:DERM) is a specialty biopharmaceutical company
focused on bringing innovative and differentiated medical
dermatology products to dermatologists and their patients.
Dermira's portfolio of five product candidates targets significant
market opportunities and includes three late-stage product
candidates, CIMZIA® (certolizumab pegol), in development in
collaboration with UCB Pharma S.A. for the treatment of
moderate-to-severe plaque psoriasis; DRM04, a topical treatment for
hyperhidrosis; and, DRM01, a topical sebum inhibitor for the
treatment of acne. Dermira is headquartered in Menlo Park,
California. For more information, please visit www.dermira.com.
About UCB
UCB, 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 8500 people in approximately
40 countries, the company generated revenue of € 3.4 billion in
2013. UCB is listed on Euronext Brussels (symbol: UCB). Follow us
on Twitter: @UCB_news
Forward looking statements - Dermira
This press release contains forward-looking statements that
involve substantial risks and uncertainties, including with respect
to planned next steps in the clinical development of our product
candidates, timing expectations for the receipt of top-line data
from the Phase 3 studies, the desired objectives of the Phase 3
studies and future milestone payments. These statements deal with
future events and involve known and unknown risks, uncertainties
and other factors that may cause our 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 outcomes of our
clinical trials, our dependence on third party clinical research
organizations, manufacturers and suppliers, our ability to obtain
regulatory approval for our product candidates, the costs of our
development programs, our ability to obtain necessary additional
capital, market acceptance of our potential products, our ability
to develop and maintain collaborations and license products and
intellectual property, the impact of competitive products and
therapies including generics and biosimilars, our ability to manage
the growth and complexity of our organization, our ability to
maintain, protect and enhance our intellectual property, and our
ability to continue to stay in compliance with applicable laws and
regulations. You should refer to the risks set forth in Part II,
Item 1A, "Risk Factors" in the Company's Quarterly Report on Form
10-Q and other filings the Company makes with the Securities and
Exchange Commission from time to time for a discussion of important
factors that may cause our actual results to differ materially from
those expressed or implied by our forward-looking statements.
Furthermore, such forward-looking statements speak only as of the
date of this press release. We undertake 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.
Forward looking statements - UCB
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.
CONTACT: For further information, Dermira:
Robert H. Uhl, Westwicke Partners,
Investor Relations, Dermira
T +858.356.5932, Robert.uhl@westwicke.com
Andrew Guggenhime, Chief Operating Officer
and Chief Financial Officer, Dermira
T +650.421.7200, investor@dermira.com
For further information, UCB:
Corporate Communications
France Nivelle, Global Communications, UCB
T +32.2.559.9178, france.nivelle@ucb.com
Laurent Schots, Media Relations, UCB
T+32.2.559.92.64, Laurent.schots@ucb.com
Investor Relations
Antje Witte, Investor Relations, UCB
T +32.2.559.94.14, antje.witte@ucb.com
Brand Communications
Eimear O'Brien, Brand Communications, UCB
T +32 2 559 92 71, eimear.obrien@ucb.com
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