UCB confirms its previous guidance that
net income after tax for the year to December 31, 2005 will be at
least EUR260 million (not including the capital gain of EUR470 million on
the sale of the Surface Specialties activities and the operating
profit of EUR9 million those activities earned in early 2005). The
better than expected sales performance in 2005 and the higher than
expected synergies enabled higher Research & Development (R&D)
investment and ongoing restructuring charges beyond the previously
announced EUR20 million.
This performance reflects the successful transformation of UCB into a
pure biopharmaceutical company following the acquisition and
integration of Celltech, and divestment of non core activities.
Keppra®, whose sales increase will exceed 30%, is the principal
driver of UCB's 2005 sales growth. The allergy franchise continues to
grow, driven by Zyrtec® in the U.S.A.([1]) and Japan([2]) and by
Xyzal® in Europe, while our mature products are continuing to perform
well.
The excellent phase III clinical results of Cimzia (TM) for the
treatment of Crohn's disease encouraged UCB to accelerate R&D and
launch-preparation investment in this product, contributing to total
R&D spend increasing to 25% of net 2005 group sales. All other major
R&D programs (except CDP 484 as announced early in the year) have
progressed according to plan.
R&D Update
Central Nervous System (CNS)
* Keppra® is confirming its position as the new standard in epilepsy
treatment.
Intravenous formulation
Regulatory filings are under review by both EMEA and FDA. The first
launch in the first quarter of 2006 is being prepared.
Primary generalised myoclonic seizures
Regulatory filings are under review by both EMEA and FDA. The first
launch by mid 2006 is being prepared.
Primary generalised tonic-clonic seizures
The submission of the regulatory file is expected by mid 2006.
Monotherapy
The submission of the European regulatory file is expected during the
first quarter of 2006.
Japan
The enrollment of the second pivotal phase III study for Keppra in
the treatment of epilepsy has started in Japan.
* Brivaracetam and Seletracetam
The phase II clinical studies are evolving according to plan and
results are expected in the second half of 2006.
Inflammation
* Cimzia (TM)
Crohn's Disease
The preparation of the regulatory files is on track and expected to
be submitted during the first quarter of 2006.
Rheumatoid Arthritis
The two phase III profiling studies are evolving according to plan
and first results are expected by the end of 2006.
Psoriasis
A phase III clinical study for the treatment of psoriasis has been
initiated and recruitment is ongoing.
* Early Prevention of Asthma in Atopic Children (EPAAC (TM))
The EPAAC (TM) study was designed to explore the efficacy of Xyzal®
beyond its already well established indications. This innovative
study examined the effectiveness of levocetirizine (Xyzal®) in the
prevention of asthma in a subpopulation of very young children with
specific family history([3]). The primary endpoint of the study was
not met. The preliminary safety analysis confirmed Xyzal®'s good
safety profile in very young children.
Oncology
CDP 791([4]), an anti-VEGF receptor-2 monoclonal antibody, is
currently in phase II clinical evaluation for the treatment of non
small cell lung cancer with results expected by the end of 2006.
Initial Trends for 2006
2006 is expected to be another year of dynamic sales growth, mainly
driven by Keppra®. Royalty income, as expected, will be impacted by
the expiry of the Boss technology patent.
UCB will significantly increase its investment in Cimzia (TM), which
is on track for regulatory filing and is being prepared for launch
during the first half of 2007. Other selling, general and
administrative expenses will be tightly managed.
We expect R&D investment to increase and be around 25% of sales in
2006, principally driven by:
Final results for 2005 will be announced on March 14th 2006 at which
time UCB will also update the market on R&D progress and on the
financial outlook for 2006.
Roch Doliveux, CEO of UCB, said, "With the successful integration of
Celltech and the tremendous achievements of my UCB colleagues, our
first full year of operations as a biopharmaceutical company has been
very encouraging, delivering rapid growth and giving us a solid base
for 2006 and beyond. 2006 will be a year of continued growth in sales
as well as significant investments for the future, including the
preparation for the Cimzia (TM) launch and further R&D progress."
About UCB
UCB (www.ucb-group.com) is a global biopharmaceutical leader with
headquarters in Brussels, Belgium, specialising in the fields of
central nervous system disorders, inflammatory diseases, and
oncology. UCB key products are Keppra® (antiepileptic), Xyzal® and
Zyrtec® (antiallergics), Nootropil® (cerebral function regulator),
Tussionex® (antitussive) and Metadate(TM) / Equasym XL(TM) (attention
deficit/hyperactivity disorder). UCB employs over 8,500 people
operating in over 40 countries. UCB is listed on Euronext Brussels
(UCB / UCBBt.BR / UCB BB).
([1]) UCB co-promotes Zyrtec in the USA with Pfizer.
([2]) Daiichi-Sankyo and GSK Japan are co-distributing Zyrtec in
Japan.
([3]) EPAAC (TM) study results: Preventive effect of levocetirizine
on the onset of asthma in children aged 1 to 2 a family history of
atopy suffering from atopic dermatitis and sensitized to house dust
mite and/or grass pollen has not been confirmed.
([4]) UCB and Imclone Systems entered in August 2005 into a
development and commercialization partnership for CDP791.
For the pdf-version of this press release, please click on the link
below:
http://hugin.info/133973/R/1025070/162731.pdf
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