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EURONEXT BRUSSELS
UCB,
with headquarters in Brussels (Belgium), is a pharmaceutical and specialty
chemical company, which operates on a global scale. It is committed to
pharmaceuticals, as well as to technically innovative products for surface
applications. It employs 12,000 people around the world. The pharmaceutical
research of UCB includes the following fields : neurology and allergy.
UCB Pharma's main products include Keppra (antiepileptic), Xyzal and Zyrtec
(antiallergics), Nootropil (cerebral function regulator) and Atarax (tranquillizer).
Keppra
XR(TM) Extended- Release Tablets Filed with the FDA
U.S.
Food and Drug Administration (FDA) has accepted for filing the New Drug
Application (NDA) for the use of Keppra XR(TM) (levetiracetam) in the adjunctive
treatment of partial onset seizures in adults with epilepsy.
Brussels,
BELGIUM - January 16, 2008 at 7:00 am CET - UCB announced today that the
New Drug Application (NDA) for the use of Keppra XR(TM) (levetiracetam)
extended- release tablets in the adjunctive treatment of partial onset
seizures in adults with epilepsy has been accepted for filing by the U.S.
Food and Drug Administration (FDA).
"This
filing is another important step in the development of UCB's epilepsy franchise
and demonstrates our commitment to bringing new and innovative therapies
to the epilepsy community." said Iris Loew-Friedrich, MD, PhD, Global Head
of Development, UCB Group. "There is an ongoing need for new antiepileptic
drug options without the limitations of twice daily dosing. Epilepsy therapies
with more convenient dosing schedules may help encourage greater patient
compliance, which is important to effective seizure control."
The
filing for Keppra XR(TM) is supported by a Phase III, multicenter, randomized,
double-blind, placebo-controlled study evaluating the efficacy, safety,
and tolerability of extended-release levetiracetam tablets (2x500 mg) once-daily
as adjunctive therapy in 158 refractory epilepsy patients, 12 to 70 years
of age, with partial onset seizures.[1]
The
study met its primary endpoint for seizure reduction over placebo during
the treatment period (p=0.038). The median per cent reduction of partial
onset seizures in the extended-release levetiracetam group was 46.1% compared
to 33.4% with placebo during the 12 week treatment period. Additionally,
24.0% of patients randomized to the extended-release levetiracetam group
had seizure frequency per week reduced by 75-100%, compared with 11.4%
of patients in the placebo group. In the extended-release levetiracetam
group 10.1% of patients had 100% reduction in partial onset seizures and
8.9% were free from any type of seizure over the treatment period, compared
to 2.5% and 1.3% in the placebo group, respectively. [1]
The
study also found that extended-release levetiracetam tablets were generally
well tolerated. The most common reported adverse events that occurred more
frequently in the extended-release levetiracetam group were somnolence,
influenza, nausea, nasopharyngitis, irritability, and dizziness.[1]
UCB
Announces Positive Top-Line Phase III Results for Keppra® as Adjunctive
Therapy for Partial Onset Seizures in Paediatric Patients from One Month
to Less than Four Years of Age
Brussels,
Belgium - April 20, 2007 at 7:00 AM CET - UCB today announced positive
top-line results from a phase III, double-blind, randomized, multi-centre,
placebo-controlled study evaluating the efficacy and tolerability of Keppra®
(levetiracetam) (20-50 mg/kg/day) as adjunctive therapy in the treatment
of partial onset seizures in children (n=116) from one month to less than
four years of age. Compared with placebo, Keppra® was shown to
significantly reduce the frequency of partial onset seizures in these paediatric
patients with consistent results across all stratified age groups.
UCB
has sold successfully its stake in Cytec Industries
Brussels
(Belgium), March 8, 2007 at 4:30 PM (CET) - UCB announced today that it
has sold all its 5,772,857 million shares held in Cytec Industries Inc.
("Cytec") for 248 million euros, realizing a capital gain of more than
20 million euros.
On
March 1, 2005, UCB sold its Surface Specialties business to Cytec. Consideration
for the transaction was 1,190 million euro in cash and 5,772,857 shares
of Cytec. The contractual lock-up period for these Cytec shares expired
on February 28, 2007.
UCB
Full-Year 2006 Financial Results
Strong
Business Performance and Strategic Move to Become a Next Generation Biopharma
Leader
The
full press release can be downloaded from the following link: Press
release (PDF)
Revenue
growth up 8% to 2.5 billion euro and on like-for-like basis, up 11%
Growth
driven by leading Keppra® performance in the USA and Europe, with net
sales up 36% to 761 million euro. Xyzal® sales up 13% and Zyrtec®
continued to grow in the U.S.A. up 12%
Investment
in Research & Development up 21% to 615 million euro focusing primarily
on Cimzia(TM) in various indications, brivaracetam, Keppra®XR,
CDP791, CDP323 and sclerostin
Profit
from continuing operations up 36% to 367 million euro, including 90 million
euro capital gains after tax on the sale of non-core business and products
off set by 30 million euro of after tax other non recurring charges. On
a like-for-like basis, profit from continuing operations up 13%
Proposed
gross dividend of 0.90 euro per share (net 0.675 euro per share)
UCB's
and SCHWARZ PHARMA's ("Schwarz") balance sheets have been consolidated
as at 31 December 2006. UCB's 2006 income statement does not include any
material impact from the acquisition of Schwarz, with the exception of
some acquisition related financial and integration charges
Brussels
(Belgium), 28 February 2007, 7:00 AM CET - UCB today announced its financial
results for the 12 month period ended 31 December 2006.
Roch
Doliveux, CEO of UCB, commented, "2006 was another landmark year for UCB
where we made significant progress in implementing the strategy set up
three years ago of becoming a next generation biopharmaceutical leader
focused on selected severe diseases. UCB generated double-digit profit
growth despite increasing investments in R&D and Sales & Marketing.
Keppra® achieved outstanding growth and is now UCB's number one product
and market leader in the USA and Europe for the treatment of epilepsy.
UCB's Allergy franchise continued to perform well and significant progress
was also made in our R&D pipeline."
"We
are especially delighted about the successful acquisition of Schwarz Pharma,
which gives UCB a global leadership position in neurology with a rich pipeline
to accelerate growth and a strengthened and more diverse product portfolio."
European
Medicines Agency Adopts Positive Opinion Recommending Approval of Xyrem®
for the Treatment of Narcolepsy with Cataplexy in Adult Patients
Brussels,
Belgium, 25 January 2007 - 5:30 PM CET - UCB today announced that the Committee
for Medicinal Products for Human Use (CHMP) of the European Medicines Agency
(EMEA) has issued a positive opinion recommending that the European Commission
grants marketing authorisation for Xyrem® (sodium oxybate) in the treatment
of narcolepsy with cataplexy in adult patients. The European Commission
is expected to issue a decision within approximately six weeks.
Narcolepsy
is a debilitating, life-long disorder. Typically beginning with excessive
daytime sleepiness during the second and third decades of life, narcolepsy
usually progresses to include disturbed night-time sleep, cataplexy, sleep
paralysis and hypnagogic hallucinations
Troy
Cox, President CNS Operations, UCB said, 'This positive opinion is encouraging
news and we now look forward to the opportunity of making Xyrem® available
to more patients in Europe with this sleep disorder. With this expanded
indication, Xyrem® would be the first and only medicine approved by
the European Medicines Agency for the treatment of narcolepsy with cataplexy
in adult patients.'
The
effectiveness of Xyrem® for the treatment of narcolepsy symptoms has
been established in three multi-centre, double-blind, placebo-controlled
studies[1-3]. The long term safety and efficacy of Xyrem® for the treatment
of narcolepsy has also been evaluated in a 12-month, open-label, multicentre
extension trial[4].
About
Xyrem® in Europe[5]
Xyrem®
was designated as an orphan medicinal product on 3 February 2003. Orphan
medicinal products are used to diagnose, prevent or treat life-threatening
or very serious conditions that are rare, with a prevalence of less than
five per 10,000 of the EU population.
Xyrem®
is indicated in Europe for the treatment of cataplexy in adult patients
with narcolepsy. Sodium oxybate, the active ingredient in Xyrem®, is
a sodium salt of gamma- hydroxybutyrate.
The
most commonly reported adverse drug reactions are dizziness, nausea, and
headache, all occurring in 10 % to 20 % of patients. Sodium oxybate is
contraindicated in patients with succinic semialdehyde dehydrogenase deficiency.
Sodium oxybate is contraindicated in patients being treated with opiods
or barbiturates.
Please
refer to the Xyrem® SmPC for full prescribing information.
UCB
announced that it has officially published today the offer document for
the takeover of SCHWARZ PHARMA AG
Brussels,
Belgium - November 10, 2006 - UCB announced that it has officially published
today the offer document for the takeover of SCHWARZ PHARMA AG. As
announced on September 25, 2006, UCB (listed on Eurolist by Euronext Brussels)
is offering 50 euros in cash and additional consideration of 0.8735 new
ordinary shares in UCB for each tendered share of SCHWARZ PHARMA.
The
offer can be accepted during the acceptance period until December 8, 2006,
24:00 hours (CET).
The
US Free Trade Commission (FTC) has allowed the waiting period to expire
without expressing any concerns, which means that from a US antitrust perspective
the transaction can go ahead. UCB expects to receive the EU
Commission's decision no later than November 21, 2006.
UCB
ANNOUNCES PROPOSED ACQUISITION OF SCHWARZ PHARMA FOR CASH AND SHARES, VALUING
SCHWARZ PHARMA AT 4.4 BILLION EUROS BUILDING THE NEXT GENERATION GLOBAL
BIOPHARMACEUTICAL LEADER
•
UCB intends to make a friendly cash and share offer for all the issued
and to be issued shares in Schwarz Pharma.
•
Schwarz Pharma’s shareholders would receive 50 euros in cash and 0.8735
of one new ordinary share in UCB, valuing each Schwarz Pharma share at
91.1 euros based on the closing price of a UCB share on 22 September 2006.
•
Schwarz Pharma’s Supervisory and Executive Boards unanimously intend to
recommend the offer.
•
The Schwarz family, owning approximately 60 per cent of the issued share
capital of Schwarz Pharma, has committed irrevocably to accept the Offer
and to hold at least 41.5 per cent of the UCB shares they receive in the
Offer until after June 2010.
•
Schwarz Pharma brings three exciting, approved and late stage new compounds,
complementary therapeutic and geographic focus, strong talent and cultural
fit.
•
The combined UCB and Schwarz Pharma would be a leading biopharmaceutical
company with: o revenues in excess of 3.3 billion euros o world leading
R&D - annual expenditure of 770 million euros o global leadership in
neurology o stronger combined commercial power in the USA and EU
o
rich neurology and inflammation pipeline accelerating growth o strengthened
and more diversified product portfolio o improved long-term earnings prospects
and cash flow profile
•
Significant anticipated synergies of more than 300 million euros per annum
to be reached after three years.
•
It is expected that the transaction would be earnings accretive, post synergies,
transaction costs and intangible amortisation related to the acquisition
after the second year of ownership
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