TIDMCSRT
RNS Number : 1874K
Consort Medical PLC
19 September 2016
Consort Medical plc
19 September 2016
UCB Receives EMA Regulatory Approval for Pre-filled Pen with
Core Bespak Technology
Consort Medical plc ("Consort Medical", "Consort" or the
"Group") (LSE: CSRT), notes the announcement from UCB that the
European Medicines Agency's (EMA's) Committee for Medicinal
Products for Human Use (CHMP) has recommended the use of CIMZIA(R)
AutoClicks(R) Prefilled Pen in all approved indications. The
positive opinion was based on validated data and risk benefit
analysis for the AutoClicks(R) Pen.
The AutoClicks(R) 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. This development programme,
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.
It is currently expected INJ570 will contribute to the
underpinning of the Board's existing expectations for the Group,
which remain unchanged from Consort's recent AGM Statement
published on 7 September 2016.
Jon Glenn, Chief Executive Officer of Consort Medical,
commented:
"We are delighted that this sophisticated Autoinjector product,
that relies on Bespak technology at its core, has received a
positive opinion from the EMA enabling its European roll-out in the
very near term. This is another important milestone for Bespak
injectable franchise with the approval of our first product into
the high value and high growth biologics market."
The full text of the UCB announcement is reproduced below:
UCB receives positive EU CHMP opinion for CIMZIA(R)
(certolizumab pegol) AutoClicks(R) Prefilled Pen
Brussels, Belgium - September 19, 2016 - UCB has announced that
the European Medicines Agency's (EMA's) Committee for Medicinal
Products for Human Use (CHMP) has recommended the use of CIMZIA(R)
AutoClicks(R) Prefilled Pen in all approved indications. The
positive opinion was based on validated data and risk benefit
analysis for the AutoClicks(R) Pen.
"At UCB, we have made it a priority to develop a true
understanding of the real world challenges for people living with
severe rheumatologic conditions and to determine the best
solutions. The availability of the AutoClicks(R) Prefilled Pen will
allow us to provide different administration options for patients
treated with CIMZIA(R) . Patients have personal preferences for
self-injection devices depending on their experience and individual
needs, so having a pen and syringe will better support patients,"
said Emmanuel Caeymaex, Head of Immunology and Executive Vice
President at UCB, Immunology Patient Value Unit, UCB.
UCB is committed to providing value to patients and meeting
their unique needs. As part of this commitment, UCB continued its
partnership with OXO(R) , a company known for its smart, consumer
friendly designs, to develop the AutoClicks(R) Pen, based on core
technology licensed from Bespak. The AutoClicks(R) 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 it makes a clicking noise
at the start of the injection and again when the injection is
complete, giving patients confidence to know they have received
their full dose of CIMZIA(R) .
Research was conducted to ensure that the AutoClicks(R) Pen
would meet the needs of patients living with autoimmune diseases
like rheumatoid arthritis. In a comparative usability study with 76
moderate to severe rheumatoid arthritis (RA) patients simulating an
injection using an injection pad, the RA patients gave the highest
rankings to the AutoClicks(R) Pen as the most preferred pen.
Patients in the study also evaluated the AutoClicks(R) Pen on a
seven point scale for its ease of use and their willingness to use
it in the future, giving it the highest score on the scale compared
to Enbrel(R) (etanercept), Humira(R) (adalimumab) and Simponi(R)
(golimumab) anti-TNF pens (p 0.05).(2) The patients in the study
had no prior experience using an anti-TNF pen. All identification
was removed from the pen devices and the instructions for use.
Devices tested at time of study were approved for use in the
UK.(1)
- ENDS -
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
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 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 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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