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Monday 05 January, 2009

UCB

UCB receives Complete Response Letter from U.S....





Brussels (Belgium), 5 January, 2009 at 6:00 pm CET - Press release -
regulated information - UCB announced today that the US Food and Drug
Administration (FDA) has issued a Complete Response Letter (CRL)
relating to the Biologics License Application (BLA) of Cimzia®
(certolizumab pegol), the first PEGylated anti-TNF, for the treatment
of rheumatoid arthritis (RA).

As a prerequisite for approval of Cimzia®, the FDA has requested a
new safety update with all clinical data including new data generated
since the filing of the BLA. The FDA has invited UCB for a meeting,
expected to take place within approximately 30 days, to define the
path forward.

"UCB is confident and committed to making Cimzia® available to people
living with moderate to severe rheumatoid arthritis and other
inflammatory conditions as soon as possible. UCB will work diligently
with the FDA to fulfill their request," said Prof. Dr. Iris
Loew-Friedrich, Chief Medical Officer of UCB.

The BLA, accepted for filing and review in February 2008, was based
on a clinical programme conducted by UCB which included more than 2
300 patients (representing more than 4 000 patient years of
experience) involved in several multi-centre placebo-controlled Phase
III trials.

On April 22, 2008, the FDA approved Cimzia® for reducing signs and
symptoms of Crohn's disease and maintaining clinical response in
adult patients with moderate to severe active disease that have had
an inadequate response to conventional therapy. Cimzia® is also
approved in Switzerland for the induction of a clinical response and
for the maintenance of a clinical response and remission in patients
with active Crohn's disease who have not responded adequately to
conventional treatment. Cimzia® is also undergoing active review by
the European authorities for the treatment of RA.

About Rheumatoid Arthritis
RA is a progressive autoimmune disease that causes chronic
inflammation of the joints. It is estimated that five million people
suffer from RA globally with 0.3 % to 1 %  of the population in
industrialized countries suffering from the disease. Women are three
times more likely to be affected than men. Although it can affect
people of all ages, the onset of RA usually occurs between the ages
of 35-55.

Traditional treatments for RA include nonsteroidal anti-inflammatory
drugs (NSAIDs), corticosteroids and disease-modifying antirheumatic
drugs (DMARDs), with biological therapies a more recent addition.

About Cimzia®
Cimzia® is the only PEGylated anti-TNF (Tumor Necrosis Factor).
Cimzia® has a high affinity for human TNF-alpha, selectively
neutralizing the pathophysiological effects of TNF-alpha. Over the
past decade, TNF-alpha has emerged as a major target of basic
research and clinical investigation. This cytokine plays a key role
in mediating pathological inflammation, and excess TNF-alpha
production has been directly implicated in a wide variety of
diseases. The U.S. Food and Drug Administration (FDA) has approved
Cimzia® for reducing signs and symptoms of Crohn's disease and
maintaining clinical response in adult patients with moderate to
severe active disease who have had an inadequate response to
conventional therapy. Cimzia® was approved in Switzerland for
induction of a clinical response and for the maintenance of a
clinical response and remission in patients with active Crohn's
disease who have not responded adequately to conventional treatment
in September 2007. UCB is also developing Cimzia® in other autoimmune
disease indications. Cimzia® is a registered trademark of UCB S.A.

For further information
Antje Witte, Corporate Communications & Investor Relations, UCB
T +32.2.559.9414, antje.witte@ucb-group.com

Richard Simpson, Investor Relations, UCB
T +32.2.559.9494, Richard.Simpson@ucb-group.com

Bert Kelly, Manager, U.S. Communications & Public Relations, UCB
T +1 770.970.8491, bert.Kelly@ucb-group.com

Scott Fleming, Global Communications Manager - Immunology UCB
T +44.770.277.7378, scott.fleming@ucb-group.com

About UCB
UCB Brussels, Belgium (www.ucb-group.com) is a global
biopharmaceutical company dedicated to the research, development and
commercialization of innovative medicines with a focus on the fields
of central nervous system and immunology disorders. Employing more
than 10 000 people in over 40 countries, UCB expects to achieve
revenue of 3.3 billion euro in 2008. UCB is listed on Euronext
Brussels (symbol: UCB). The company's U.S. headquarters is located in
Atlanta.

Forward looking statement
This press release contains forward-looking statements based on
current plans, estimates and beliefs of management. Such statements
are subject to risks and uncertainties that may cause actual results
to be materially different 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, effects of
future judicial decisions, changes


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