Richard Davies wrote: The UK has a good crop of technology pioneers in cloud computing - for example ElasticHosts, FlexiScale, Flexiant, OnApp - and also some strong government initiatives such as G-Cloud.
We will have to see whether this kind of technical leadership converts into swift mass-market adoption or not.
Radiographic Data Demonstrated Significant Reduction in Joint
Damage
Brussels (Belgium), February 23, 2007 at 7:00 AM CET - UCB
today
announced key results of a pivotal Phase III study (RAPID
1)
involving nearly 1,000 patients on CIMZIA(TM) (certolizumab
pegol),
the first PEGylated, Fc-free anti-TNF, intended for the treatment
of
moderate to severe rheumatoid arthritis (RA). RAPID 1's
radiographic
data showed that CIMZIA(TM) in combination with
methotrexate
prevented structural damage of the joints to a significantly
greater
degree than placebo plus methotrexate after one year's treatment.
RAPID 1 achieved its co-primary endpoint, the inhibition
of
progression of structural damage, with a statistically
significantly
smaller change from baseline in modified Total Sharp Score
(mTSS)[a]
observed at week 52 in both CIMZIA(TM) treatment arms (400mg at
week
zero, week two and week four followed by 200mg every two weeks;
or
400mg every two weeks) compared with the placebo treated
arm
(p < 0.001).
The study also showed that in both active treatment arms
CIMZIA(TM)
improved the signs and symptoms of RA to a clinically
statistically
significantly greater degree than the placebo arm in patients who
had
inadequately responded to methotrexate alone (p < 0.001).
Similar results were observed with a second pivotal Phase III
study
of CIMZIA(TM) in RA, RAPID 2, using CIMZIA(TM)'s new
subcutaneous
liquid formulation.
In both RAPID 1 and RAPID 2, the primary endpoint, ACR 20
response[b]
at 24 weeks, was significantly higher in both CIMZIA(TM) treated
arms
than in the placebo treated arm (p < 0.001) . In both studies
there was
no significant difference between response levels in either of
the
CIMZIA(TM) treatment arms. ACR 50 and ACR 70 responses were
also
both achieved with statistical significance in both studies.
RAPID 1 and RAPID 2 demonstrated that effective results in
the
treatment of RA can be achieved with a 400mg total monthly dose
of
CIMZIA(TM) -- a higher dose is not necessary.
"These results are significant. They showed, for the first time,
that
the Fc region present in conventional anti-TNFs is not required
for
activity in rheumatoid arthritis", commented Professor
Edward
Keystone, Professor of Medicine, University of Toronto,
Canada.
"These data confirm that certolizumab pegol may provide a
valuable
new treatment option for patients with this condition."
CIMZIA(TM) was also shown to have a rapid onset of
action:
approximately three-quarters of actively-treated patients,
who
achieved ACR 20 at week 24, actually reached ACR 20 within
four
weeks.
"The RAPID 1 and 2 studies showed consistent and robust efficacy
with
both the lyophilized and liquid formulations of certolizumab
pegol,"
added Professor Joseph Smolen, Chairman of the Department
of
Rheumatology, Medical University of Vienna, Austria.
"Interestingly,
both studies show that maximal response can be achieved as early
as
12 to 16 weeks."
The safety and tolerability profile of CIMZIA(TM) in both studies
was
consistent with that expected of an anti-TNF agent.
Further data from both RAPID 1 and RAPID 2 will be presented at
major
international rheumatology congresses later this year. Preparation
for a licence submission in the treatment of RA is ongoing, with
filing planned in the second half of 2007.
Enquiries, please contact:
Investor Relations International Media
Jean-Christophe Donck, UCB Garry Daniels, UCB
Phone: +32.2.559.9346 Phone : +44.1753.777.116
E-mail: jc.donck@ucb-group.com Email:garry.daniels@ucbgroup.com
Mareike Mohr Richard Kenyon
Phone: +32 2 559 9246 Fleishman-Hillard
Email: mareike.mohr@ucb-group.com Phone: +44 7831 569940
E-mail:kenyonr@fleishmaneurope.com
U.S. Media
Emily Wilson,
Fleishman-Hillard
Phone: TBC
E-mail: emily.wilson@fleishman.com
[a] The mTSS (modified Total Sharp Score) assesses bone erosion
and
joint space narrowing measured by X-ray. A smaller change in mTSS
reflects less progression of joint damage.[1]
[b] ACR (American College of Rheumatology) response scores measure
improvement in the tender and swollen joint count and also include
assessment of the following five parameters: patient's global
assessment, physician's global assessment, patient's assessment of
pain, degree of disability, and level of acute-phase reactant.
ACR20
is achieved when there is 20% improvement in the tender and
swollen
joint count as well as a 20% improvement in at least three of the
five parameters. ACR50 & ACR70 are an extension of these criteria
corresponding to a 50% and 70% improvement respectively.[2]
[1]. Sharp JT, Lidsky MD, Collins LC, Moreland J. Methods of
scoring
the progression of radiologic changes in rheumatoid arthritis:
Correlation of radiographic, clinical and laboratory
abnormalities.
Arthritis & Rheumatism , 1971, Vol. 14, No. 6
[2]. American College of Rheumatology Subcommittee on Rheumatoid
Arthritis Guidelines. Guidelines for the Management of Rheumatoid
Arthritis 2002 update. Arthritis & Rheumatism, 2002 Vol. 46, No. 2
For the pdf-version of this press release, please click on the
link
below: