SLOUGH, England, October 25, 2016 /PRNewswire/ --
- UCB leads collaboration to design a
prefilled pen for patients with rheumatic
diseases
- Prefilled Pen designed for ease of use during
self-injection
UCB today announces that the new certolizumab pegol
(Cimzia®) AutoClicks® Prefilled Pen is now available on
the NHS following the recent positive opinion by the European
Medicine's Agency's (EMA) Committee for Medicinal Products for
Human Use (CHMP).[1] The EMA's
CHMP decision recommended the use of Cimzia®
AutoClicks® Prefilled Pen in all approved indications
(rheumatoid arthritis, active psoriatic arthritis, ankylosing
spondylitis [AS] and axial spondyloarthritis
[axSpA]).[2] The positive opinion
was based on validated data and risk benefit analysis for the
AutoClicks® Prefilled
Pen.[1]
UCB is committed to providing value to patients and meeting
their unique needs. As part of this commitment, UCB continued
its partnership with OXO, a company known for thoughtful,
consumer-friendly designs, to develop the AutoClicks®
Prefilled Pen, based on core technology licensed from Bespak.
The AutoClicks® Prefilled Pen provides a
button-free delivery system and a wide non-slip grip that keeps
patient hand disability in mind. It has a large viewing
window that shows the progress of the injection and shows that they
have administered it correctly with two clicks which indicate when
the injection has started and when it has finished, giving patients
the confidence to know they have received their full dose of
certolizumab pegol.[3]
Dr Ravik Mascarenhas, Consultant Rheumatologist at the Royal
Devon & Exeter Foundation Trust said, "I see many
patients whose joints have been destroyed by this painful disease
so having a new choice is welcomed. Like most of us
they also tend to find it a challenge self-injecting because of a
needle - with this new pre-filled pen the
patient doesn't even see the needle which
may take some of the nerves and fear
away."
In the UK the monthly cost to the NHS for treating a patient
using the certolizumab pegol AutoClicks® Prefilled Pen
is £715 (2 treatments doses of
200mg).[2]
Ailsa Bosworth, Chief Executive
of the National Rheumatoid Arthritis Society, who was diagnosed
with RA 30 years ago said: "It is difficult for people
who do not suffer from this disease to understand just how
challenging doing the ordinary things in daily
life can be, more so for those with painful and swollen joints.
Trying to grip an everyday object such as a kitchen gadget can
cause immense pain. So we welcome any innovation that can help make
the lives of RA patients more comfortable while they manage their
condition."
About UCB
UCB, Brussels, Belgium (
http://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).
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.
About OXO
Founded in 1990 on the concept of Universal Design, OXO's
mission is to create consumer household products that ease the
tasks of everyday life for the widest range of users possible.
Since the original 15 Good Grips items were introduced, the OXO
collection has grown to more than 1,000 strong, covering many rooms
of the house and tasks including cooking, baking, cleaning,
brewing coffee, storing, organizing, childcare and more.
Headquartered in New York City,
the company's products are sold in more than 80
countries and are included in the permanent collections of numerous
museums. The company has won more than 100 design and business
awards worldwide and is frequently used as a case study on how a
well-executed Universal Design philosophy can be a successful
business strategy.
OXO and Good Grips® are trademarks owned and/or licensed by
Helen of Troy Limited (NASDAQ, NM: HELE), and are used by UCB under
license.
About Bespak
Bespak, a Consort Medical company, is a full-service drug
delivery partner, specialising in innovative patient-centric
medical devices. With nearly 60 years' experience in
drug delivery Bespak applies its proven know how and technologies
to address the ever changing needs of the pharmaceutical industry,
across multiple applications.
Bespak partners with customers to design and develop drug
delivery devices, as well as providing contract device
manufacturing from pilot to commercial scale. As part of the
Consort Medical Group, Bespak works with its Aesica colleagues to
offer customers an accelerated route to market through a
streamlined service, at any stage of the development cycle.
For more information, please visit:
http://www.bespak.com
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
EU/EEA
In 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/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 17th December
2015.
http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/001037/WC500069763.pdf
CIMZIA® is a registered trademark of the UCB Group of
Companies.
References
1. EMA CHMP UCB Data on File
2. UCB Data on File - Prescribing
Information
3. UCB Data on File Comparative Usability
Study
4. Domanska B et al. Ann Rheum Dis.
2016;75(Suppl2):1002. Abstract AB0300
For further information
Avril
O'Connor, Brand Communications Manager
UCB, British & Irish Isles
T: +44(0)7736-120044
E: avril.oconnor@ucb.com
SOURCE UCB