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UCB (EBR:UCB) * 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 naïve 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 €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.
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