UCB: Interim Report - Cimzia®, Vimpat® and Neupro® build momentum
2010-04-29 07:04:03 -
- Financial performance in-line with company expectations
- Continuing roll-out of major new products Cimzia(®), Vimpat(®) and
Neupro(®) - Start of Phase I study for antibody fragment CDP7657
- Financial outlook 2010 confirmed
Brussels (Belgium), April 29, 2010 - 07:00 (CEST) - regulated information - UCB
announced today its interim report for the first quarter of 2010.
"In the first three months of 2010 more than 116000 patients benefited from
UCB's new medicines," said Roch Doliveux, CEO of UCB. "Our new products
Cimzia(®), Vimpat(®) and Neupro(® )are building momentum and laying the
foundation for UCB's future growth. After the first three months we are also
delighted to confirm that we are on track to deliver our guidance."
The new products Cimzia(®), Vimpat(®) and Neupro(®) showed solid growth with
multiple new launches proceeding as planned across various European countries.
In addition, the company's anti-epileptic drug, Keppra(®) (levetiracetam),
continued to grow in most European countries, due to continued increase in its
use in monotherapy. The growth drivers largely offset the expected revenue
decline in the first quarter 2010 compared to the same period in 2009 due to the
effect of Keppra(®) U.S. patent expiry and the impact of the divestitures to
GlaxoSmithKline (GSK) and Shire made at the end of March 2009. Underlying
profitability (recurring EBITDA) and net profit performance were also in line
with the company's expectation.
New product launches
The roll-out of Cimzia(® )(certolizumab pegol) in the U.S. and in Europe
continues with now more than 11 300 patients treated with the drug worldwide.
Cimzia(® )has established strong loyalty among specialist physicians and
patients in the U.S. and Switzerland for the treatment of Crohn's Disease.
Prescription data for Cimzia(®) in rheumatoid arthritis is promising in every
one of the countries where it is available now: U.S., Denmark, Finland, Germany,
Netherlands, Norway, Sweden and U.K. The number of prescriptions for Cimzia(®)
in the treatment of Crohn's disease (CD) and rheumatoid arthritis (RA) in the
U.S. is growing faster than competition with a 18.2%[1] and a 3.4%[2] share
respectively of new prescriptions (NRx) in the subcutaneous anti-TNF market.
The new anti-epileptic drug, Vimpat(®) (lacosamide) made a good start in the 17
markets where UCB has already launched with more than 50 000 patients benefiting
from the drug. Available in Europe and in the U.S. as an add-on therapy for the
treatment of partial-onset seizures, Vimpat(®) continues to gain market share.
The successful launch in the U.S. epilepsy market is reflected by a strong
prescription take-off: 2.1% NRx shares[3]. Additionally, Vimpat(®) is growing
rapidly in Europe with treatment day shares (TDx) among new anti-epileptic drugs
(AEDs) with 2.4%[4] in Germany, for example.
The launch roll-out of Neupro(® )(rotigotine) continues in Europe during the
first quarter of 2010. Since the approval by the European Commission in June
2009 for UCB to again promote Neupro(® )for Parkinson's disease, and to launch
the drug for restless legs syndrome, more than 54 700 patients are currently
being treated with the drug in Europe. Neupro(® )is now available in Germany,
Italy, Spain and the U.K. and in 15 other European markets for Parkinson's
disease. Treatment day shares (TDx) in Parkinson's disease reached 15.1%[5] in
Spain. Neupro(®) is now launched in Germany, the U.K., Ireland and Austria for
restless legs syndrome. Launches in other European markets are following.
In the U.S., Food and Drug Administration (FDA) has provided end of last week a
Complete Response Letter recommending the reformulation of Neupro(®) before
making it available in the U.S. market for the treatment of Parkinson's disease
and restless legs syndrome. FDA's response is to an NDA Supplement UCB submitted
in June 2009, with a proposal for new refrigerated storage conditions to
alleviate crystallisation on the patches. While FDA agreed that the proposed new
refrigeration conditions significantly inhibit the degree of crystallisation on
the patches, they have recommended that the definitive resolution of the
crystallisation is to reformulate the drug product. This FDA decision does not
impact product supply and availability in Europe and other countries. It also
does not change previous assessments made by the European and other countries'
authorities regarding the cold chain storage process. UCB has already been
working on a room-temperature, stable improved formulation of Neupro(®) and has
made significant progress in this area. Neupro(®) has made a meaningful
difference for many people with Parkinson's disease and restless legs syndrome.
UCB is committed to obtaining FDA approval so that people in the U.S. who live
with these diseases can benefit from Neupro(®).
New project for the development pipeline
In the area of immunology, a new compound was introduced to the Phase I
programme: CDP7657, a humanised anti-CD40L antibody fragment which acts by
preventing the interaction between CD40L on T cells with CD40 on antigen
presenting cells. CDP7657 was developed with UCB's innovative technologies and
is run in collaboration with Biogen Idec (NASDAQ: BIIB). The drug candidate is
targeted at patients with systemic lupus erythematosus (SLE) and this Phase I
study includes both healthy volunteers and patients with SLE.
Outlook 2010 unchanged
Total revenue is expected to reach approximately EUR 3.0 billion in 2010. This
reflects generic and mature products erosion as well as impacts of the
divestitures made early 2009. These impacts should be partially offset by the
growth of the newly launched products Cimzia(®), Vimpat(®) and Neupro(®).
In 2010, UCB's recurring EBITDA is expected to reach approximately EUR 700
million. Core EPS[6] 2010 is expected to reach approximately EUR 1.76 (based on
180 million non-diluted shares).
For further information
Antje Witte, Investor Relations UCB
T +32.2.559.9414,[email protected] <mailto:[email protected]>
Richard Simpson, Investor Relations, UCB
T+32.2.559.9494,[email protected] <mailto:[email protected]>
Michael Tuck-Sherman, Investor Relations, UCB
T +32.2.559.9712,[email protected]
<mailto:[email protected]>
Nancy Nackaerts, External Communications, UCB
T +32.473.864.414 or +32.2.559.92.64,[email protected]
<mailto:[email protected]>
About UCB
UCB, Brussels, Belgium (www.ucb.com <http://www.ucb.com>) is a 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 9 000 people in over 40 countries, UCB
produced revenue of EUR 3.1 billion in 2009. 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 its employees.
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[1] IMS Xponent weekly prescriptions for CD in U.S., week ending 16 April 2010
[2] IMS National Prescription Audit (NPA) Weekly for RA in U.S., week ending 16
April 2010
[3] IMS National Prescription Audit, February 2010- New AED epilepsy use
[4] IMS retail Feb 2010, UCB calculations.
[5] IMS retail Feb 2010, UCB calculations.
[6] Core EPS (earnings per share) are calculated to reveal the inherent
sustainable value of the net profit. For this calculation, per share net profit
after minorities is adjusted for the after tax effects of non-recurring items
(e.g. impairment and restructuring charges, extraordinary income, one-time
financial or tax related expenses) and for the after tax impact of amortisation
charges of intangible assets.