TIDMCSRT
RNS Number : 5673N
Consort Medical PLC
27 October 2016
Consort Medical plc
27 October 2016
UCB CIMZIA(R) AutoClicks(R) prefilled pen launched in the UK
Consort Medical plc ("Consort Medical", "Consort" or the
"Group") (LSE: CSRT), notes the announcement from UCB, dated 26
October 2016, that the new certolizumab pegol (Cimzia(R))
AutoClicks(R) 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).
This follows the EMA's CHMP decision recommending the use of
Cimzia (R) AutoClicks(R) prefilled pen in all approved indications,
announced on 19 September 2016. The AutoClicks(R) prefilled pen is
referred to as INJ570 in the Consort development portfolio.
Jon Glenn, Chief Executive Officer of Consort Medical,
commented:
"We are delighted that the AutoClicks(R) prefilled pen
autoinjector, which relies on Bespak technology at its core, has
been launched in the UK market. This further significant milestone
for the Bespak injectable franchise builds on the commercialisation
of INJ300 for Dr. Reddy's Sumatriptan autoinjector in 2014 and the
recent signing of the Syrina(R) autoinjector master development
agreement, announced earlier this month."
The full text of the UCB announcement is reproduced below:
UCB announces availability of Cimzia AutoClicks Prefilled Pen on
NHS in UK
Slough, England, Wednesday, October 26, 2016, 11:00 Hrs
[IST]
UCB, a global biopharmaceutical company, announced 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). 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]). The positive
opinion was based on validated data and risk benefit analysis for
the AutoClicks Prefilled Pen.
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.
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 GBP715 (2
treatments doses of 200mg).
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."
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.
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.
-S -
Enquiries:
Consort Medical Tel: +44 1442 867920
Jonathan Glenn - Chief Executive
Officer
Richard Cotton - Chief Financial
Officer
FTI Consulting Tel: +44 20 3727 1000
Ben Atwell / Simon Conway
About Consort Medical
Consort Medical plc is a leading, global, single source drug and
delivery device company (CDMO). We are at the leading edge of
innovation and we are committed to investing in patient, clinician
and customer driven innovation to create new treatments, new
markets and new opportunities.
Our businesses
Bespak is a global market leader in the manufacture of drug
delivery devices for pharmaceutical partner companies, including
respiratory, nasal, and injectable products, and the manufacture of
devices for the point of care diagnostics market.
www.bespak.com.
Aesica is a leading provider of finished dose and active
pharmaceutical ingredient (API) development and manufacturing
services to pharmaceutical partners. www.aesica-pharma.com.
We employ more than 2000 people globally of which 1400 are
located in the UK. We have UK facilities in King's Lynn, Cambridge,
Nelson, Milton Keynes, Cramlington, Queenborough and Hemel
Hempstead, German facilities in Monheim and Zwickau and a facility
in Pianezza, Italy. Consort Medical is a public company quoted on
the premium list of the London Stock Exchange (LSE: CSRT).
www.consortmedical.com.
About AutoClicks(R) prefilled pen
The AutoClicks(R) prefilled pen is based on core technology
licensed from Bespak, a Consort subsidiary and an established
global market leader in the manufacture of drug delivery devices
for pharmaceutical partner companies. The approval and launch of
the AutoClicks(R) prefilled pen, referred to as INJ570 in the
Consort development portfolio, follows the successful approval,
launch, and commercialisation of INJ300 for Dr. Reddy's Sumatriptan
autoinjector in 2014.
The AutoClicks(R) 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.
About CIMZIA(R)
CIMZIA(R) is the only Fc-free, PEGylated anti-TNF (Tumor
Necrosis Factor). CIMZIA(R) has a high affinity for human
TNF-alpha, selectively neutralizing the pathophysiological effects
of TNF-alpha.
About CIMZIA(R) in the EU/EEA
In the EU, CIMZIA(R) 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(R) can be given as monotherapy in case of intolerance to
MTX or when continued treatment with MTX is inappropriate.
CIMZIA(R) 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(R) 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(R) , 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(R) can be
given as monotherapy in case of intolerance to methotrexate or when
continued treatment with methotrexate is inappropriate.(3)
CIMZIA(R) is also indicated in the EU for the treatment of adult
patients with severe active axial spondyloarthritis (axSpA),
comprising:(4)
-- 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)
For full safety and prescribing information please consult the
document in the following link. European SmPC date of revision
17(th) December 2015.
http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/001037/WC500069763.pdf
CIMZIA(R) is a registered trademark of the UCB Group of
Companies.
REFERENCES
1. UCB. Data on file (Comparative Usability and Validation Study
for CIMZIA(R) pre-filled pen - Study Report, Sections 8.2.1.1,
8.2.2.4, and 8.2.2.5). 2013.
2. Domanska B et al. Ann Rheum Dis. 2016;75(Suppl2):1002. Abstract AB0300
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 7 700 people in
approximately 40 countries, the company generated revenue of EUR
3.9 billion in 2015. UCB is listed on Euronext Brussels (symbol:
UCB). Follow us on Twitter: @UCB_news
This information is provided by RNS
The company news service from the London Stock Exchange
END
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