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UCB on track
(Marketwire Via Acquire Media NewsEdge) BRUSSELS, BELGIUM, October 31 / MARKET WIRE/ --
* UCB on track to achieve 2008 and 2009 financial outlook
* Three new drug launches in nine months
* Continued roll-out of strategy
* Early research with two new external partnerships
Brussels, Belgium, October 31, 2008 at 7:00 AM (CET) - press release,
regulated information - UCB announced today that the financial
performance of the UCB Group in the first nine months of 2008 was
in-line with the company's financial outlook 2008.
"In the first nine months, UCB has achieved several regulatory
milestones in its core fields of CNS and immunology disorders, and
launched the SHAPE initiative", said Roch Doliveux, CEO of UCB. "In
April, we launched Cimzia? for the treatment of Crohn's disease in
the U.S. In September, we launched two new medicines for the
treatment of adjunctive therapy in epilepsy: Vimpat? in Europe and
Keppra? XR in the U.S. UCB's pipeline is progressing and we are on
track to achieve our full-year financial goals. Implementation of the
SHAPE initiative, which redeploys resources on our core activities
while improving competitiveness and profitability, has begun.
Implementation and related social procedures in the countries
involved are ongoing in constructive dialogue with our social
partners."
UCB's revenue line decreased during the first nine months of 2008 by
a mid-single digit percentage rate compared to the same period in
2007, due to the loss of Zyrtec? (cetirizine) patent in the US in
December 2007. Revenues remained stable when excluding the impact of
currency fluctuations. Key products contributing to growth were
Keppra? (levetiracetam), Xyzal? (levocetirizine) and Tussionex?
(hydrocodone polistirex and chlorpheniramine polistirex) all of which
continued to deliver strong double-digit percentages in revenue
growth. Keppra? is expected to face generic competition in the U.S.
from early November 2008.
In the first nine months, recurring EBITDA (Earnings Before Interest,
Taxes, Depreciation and Amortization) was on track with full-year
expectations.
New product launches
The launch of Cimzia? in the U.S. for the treatment of Crohn's
Disease continues with over 2 300 patients being prescribed the
product since launch in April 2008. Over the same period, more than 5
200 gastroenterologists have enrolled in UCB's CIMplicity(TM)
program, and 1 200 have prescribed Cimzia? so far. While data are
based on a sample they suggest that the majority of patients treated
are na?ve to anti-TNF treatment.
At the end of August 2008, Vimpat? (lacosamide) was approved in the
EU as adjunctive therapy for the treatment of partial-onset seizures
in adults with epilepsy. Within days, the drug was launched in
Germany and the UK. Epilepsy specialists have responded positively to
the launch of Vimpat? and several hundred patients have already been
prescribed the drug as add-on to their current medication. Further
European launches are expected to take place in the coming months. At
the end of October, Vimpat? was approved in the U.S. as adjunctive
therapy for partial onset seizures in adults with epilepsy. Vimpat?
will be launched in the U.S. in early 2009 by the well established
UCB epilepsy team.
Keppra? XR, an extended release formulation of levetiracetam, was
launched at the end of September in the U.S.
A complete cold-chain storage and distribution system for the
Parkinson's disease medicine Neupro? (rotigotine) was successfully
implemented throughout Europe in September 2008. Pending European
authority decision, UCB plans to make Neupro? available again to all
patients (including new patients) in Europe, and to launch the
Restless Legs Syndrome indication in Europe, during the first half of
2009. Also in the first half of 2009, UCB intends to initiate a
dialogue with the U.S. Food and Drug Administration (FDA) about the
re-launch of Neupro? in the U.S.
R&D update
On 1 July 2008, the European Marketing Authorisation Application for
Cimzia? for the treatment of rheumatoid arthritis was accepted for
review by the European Medicines Agency (EMEA). In the U.S., review
of Cimzia? by the FDA for the treatment of rheumatoid arthritis is
ongoing.
At the end of July, UCB received an action letter ('not-approvable'
letter) from the FDA for lacosamide in the treatment of diabetic
neuropathic pain (DNP) in adults. At the end of September, UCB
withdrew the EU marketing authorisation application for lacosamide in
DNP. UCB has taken this decision based on the view of the EMEA's
Committee for Medicinal Products for Human Use (CHMP) that the
magnitude of the clinical effect of lacosamide in DNP has not been
convincingly established. UCB is considering initiating an additional
clinical trial to further substantiate the magnitude of effect of
lacosamide in DNP.
UCB has a number of potential treatment options for fibromyalgia. It
is anticipated that preliminary data from the first Phase III trial
of Xyrem? in this indication will be available at the end of 2008.
Rotigotine's Phase II (proof of concept) results are also expected
around the end of 2008. Following inconclusive Phase IIa results, a
decision whether to start Phase IIb with lacosamide to treat
fibromyalgia will be made at the same time. Phase II (proof of
concept) results for lacosamide in migraine prophylaxis are expected
at the end of this year.
Several mid-stage clinical studies involving UCB drugs are moving
forward. Phase II results for CDP323, an oral small molecule VLA4
inhibitor being developed for relapsing forms of multiple sclerosis
(MS), are expected in the first quarter of 2010. This delay is due to
the high demand for patients from a number of later-stage MS studies.
UCB and its partner Biogen IDEC expect the CDP323 Phase II clinical
trial to be fully enrolled by mid-2009.
Consistent with the UCB NewMedicines initiative, UCB is strengthening
its early research capabilities through external partnerships. The
company has announced two government-funded research collaborations
in recent weeks. With Bonn University in Germany, and certain
industry partners, UCB has been selected to receive funding of EUR 20
million over the next three years. This will allow the company to
establish a project portfolio, proprietary to UCB, of up to six drug
discovery projects in the Central Nervous System area. In a separate
research collaboration, UCB and Pfizer announced the formation of a
new company, "Cyclofluidic", a breakthrough technology organization
established with the aim of significantly accelerating the drug
discovery process. The UK Government's Technology Strategy Board has
helped facilitate this innovative arrangement and will continue to
support "Cyclofluidic" by co-funding its R&D.
Financial outlook 2008 and beyond confirmed
In October 2008, UCB was able to reach an agreement with a third
party who had reserved its right to challenge certain royalty
payments. The agreement permits UCB recognition of deferred revenue
as royalty income in the fourth quarter 2008. While such royalties
will no longer be received, in previous years this royalty income has
not been recognized in UCB's results. Therefore, for the Full Year
2008, revenue is expected to exceed EUR 3.3 billion and UCB's
recurring EBITDA is expected to reach approximately EUR 720 million,
previous financial outlook was EUR 650 million. Further details will
follow with the full financial results for 2008 which will be
published on 3 March 2009. The net result as reported will be
significantly impacted by the one-time effects of the SHAPE
initiative.
UCB confirms its 2009 financial outlook with recurring EBITDA in 2009
expected to reach at least EUR 650 million, increasing thereafter
based on growth from newly-launched products. UCB's net result as
reported in 2009 might also be impacted by one-time effects related
to the SHAPE initiative.
Further information
Antje Witte, Corporate Communications & Investor Relations, UCB Group
T +32.2.559.9414, Antje.witte@ucb-group.com
Mareike Mohr, Investor Relations, UCB Group
T +32.2.559.9264, Mareike.mohr@ucb-group.com
Michael Tuck-Sherman, Investor Relations, UCB Group
T +32.2.559.9712, Michael.Tuck-Sherman@ucb-group.com
About UCB
UCB, Brussels, Belgium (www.ucb-group.com) is a global
biopharmaceutical company dedicated to the research, development and
commercialisation of innovative medicines focused on central nervous
system and immunology disorders. Employing more than 10,000 people in
over 40 countries, UCB achieved revenues of 3.6 billion euro in 2007.
UCB is listed on Euronext Brussels (symbol: UCB).
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 in regulation, exchange rate
fluctuations and hiring and retention of employees.
For the pdf-version of this press release, please click on the link
below:
http://hugin.info/133973/R/1265081/278240.pdf
This announcement was originally distributed by Hugin. The issuer is
solely responsible for the content of this announcement.
Copyright ? Hugin AS 2008. All rights reserved.
Copyright ? 2008 Marketwire
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