UCB on Track
- UCB confident to exceed financial guidance for 2007
- UCB provides financial outlook for 2008
Brussels (BELGIUM), 14 December 2007 at 7:00 AM CET - UCB is today providing an update on recent clinical developments as well as on its previous financial guidance for 2007. UCB is also providing a financial outlook for 2008.
Roch Doliveux, CEO of UCB, comments on UCB's performance in the second half of 2007: "UCB is well on track to deliver on its targets for 2007. With our promising pipeline, we are making significant progress to become the next generation biopharma leader. With resilience and focus, we are working on our execution phase."
In the second half of 2007, UCB successfully launched in the United States Neupro® (rotigotine transdermal system) and Xyzal® (levocetirizine dihydrochloride) and reached the following major pipeline milestones across its three core areas of strategic focus:
Central Nervous System (CNS) disorders:
Vimpat® (lacosamide) has been filed with European and US regulatory authorities for the adjunctive treatment of partial onset seizures in adults with epilepsy and for the treatment of diabetic neuropathic pain.
Neupro® (rotigotine transdermal system) has been filed with European and US regulatory authorities for the treatment of moderate to severe Restless Legs Syndrome (RLS). Neupro® has also been filed with the US regulatory authorities as adjunctive therapy with levodopa in adult patients with advanced stage Parkinson's disease.
UCB reported positive Phase III results from a study evaluating Keppra® XR (levetiracetam), a once daily extended release formulation as adjunctive therapy in refractory epilepsy patients with partial onset seizures. The study met its primary endpoint for seizure reduction over placebo during the treatment period. Keppra® XR was well tolerated. A US regulatory filing for Keppra® XR is foreseen in Q1 2008. For Keppra® XR a withdrawal to monotherapy trial has been initiated in the USA with results expected in H2 2009.
The Phase III clinical programme for Rikelta(TM) (brivaracetam) has started as adjunctive therapy in patients with refractory partial-onset epilepsy. Results are expected in the third quarter 2009.
Rikelta(TM)'s first Phase III study in Unverricht Lundborg Disease (ULD) has been completed. The trial did not meet the primary endpoint of symptom relief of action myoclonus, but has shown beneficial effects in secondary analyses. Full results including an analysis of secondary endpoints as well as data from the second Phase III trial are expected to be available in Q2 2008. UCB has broken new ground as the first company to engage in regulatory studies aimed at one of the most severe Progressive Myoclonic Epilepsies.
The proof of concept trial (Phase IIa) with lacosamide in osteoarthritic pain was terminated. Based on the outcome of a first interim analysis, which was performed as defined in the protocol in a subset of patients, it was decided not to continue the trial due to futility. No safety concerns were identified.
Inflammation & Autoimmune disorders:
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has adopted a negative opinion on the market authorisation application for Cimzia® (certolizumab pegol) in the treatment of patients with Crohn's disease. UCB has submitted an appeal requesting a CHMP re-examination of the opinion. A decision is expected during the first half of 2008.
The regulatory application of Cimzia® in rheumatoid arthritis in the US has been submitted, acceptance is expected in January 2008. Filing in Europe is planned for H1 2008.
UCB completed a Phase II re-treatment study for Cimzia® in psoriasis with patients who had relapsed during the off treatment period of the initial Phase II study. Results show that the majority of the re-treated patients are able to re-capture response: 72% for the low dose group (200 mg EOW) and 91% for the high dose group (400 mg EOW) reached PASI75. Re-treatment with Cimzia® was well tolerated. UCB is finalising the further development plans for Cimzia® in psoriasis with an update expected in the first half of 2008.
Analyses of recently closed clinical trials for epratuzumab in the treatment of systemic lupus erythematosus (SLE) suggest a favourable efficacy and tolerability profile. The US open-label extension study for those patients benefiting from treatment during the initial studies is still ongoing. A Phase IIb dose ranging study with epratuzumab for SLE is scheduled to commence in the first quarter 2008 with results anticipated in the first half of 2009.
UCB is collaborating with Amgen to develop a sclerostin antibody, a novel anabolic therapy for bone loss disorders. Results from a Phase I rising single dose study were presented at the American Society for Bone and Mineral Research (ASBMR) congress in September 2007. Anti-sclerostin was generally well-tolerated, and no dropouts due to adverse events were observed. Single doses up to 10 mg/kg SC resulted in dose-related increases in bone formation markers (e.g. P1NP) and decreases in bone resorption markers (e.g. sCTX). Increases in bone mineral density were observed as early as one month post-dose. UCB and Amgen are encouraged by the first-in-human data and are currently planning the future development programme.
A Phase IIa trial with CDP791 to treat non-small cell lung cancer has been completed. The observation of the patients for progression free survival is ongoing. Results are expected when data are sufficiently mature (80% of the events have occurred), most likely in the first quarter 2008.
A Phase I/II trial with CMC544 in combination with rituximab to treat Non-Hodgkin's Lymphoma (NHL), a project partnered with Wyeth, is continuing and preliminary data are encouraging. Further analysis is ongoing and data are expected to be presented during 2008. A Phase III study has started to evaluate CMC544 in follicular NHL in combination with rituximab. Results of this study are expected in 2011.
UCB confident to exceed financial guidance for 2007:
UCB anticipates revenue for the full year 2007 to slightly exceed last year's pro forma revenue of € 3.5 billion. Recurring EBITDA is expected to exceed € 720 million, while reported net profit for 2007 is expected to exceed € 100 million. Full financial results for 2007 will be published on 29 February 2008.
Financial outlook for 2008:
2008 will again be a year of continuous progress in the execution of UCB's strategy and of substantial investment in the company's future growth. Revenue is expected to decrease to approx. € 3.4 billion due to the patent expiry of Zyrtec® in the US. Recurring EBITDA for the full year 2008 is expected to reach approximately € 650 million. Net profit is expected to exceed € 100 million in 2008.
UCB, Brussels, Belgium (www.ucb-group.com) is a global leader in the biopharmaceutical industry dedicated to the research, development and commercialisation of innovative pharmaceutical and biotechnology products in the fields of central nervous system disorders, allergy/respiratory diseases, immune and inflammatory disorders and oncology. UCB focuses on securing a leading position in severe disease categories. Employing around 12,000 people in over 40 countries, UCB achieved revenue of 3.5 billion euro in 2006 on a pro forma basis. UCB S.A. is listed on the Euronext Brussels Exchange and, through its affiliate, owns approx. 89% of the shares of SCHWARZ PHARMA AG. SCHWARZ PHARMA AG (Monheim, Germany) is a member of the UCB Group.
Antje Witte, Vice-President Corporate Communications & Investor Relations, UCB Group
T +32.2.559.9414, Antje.email@example.com
Mareike Mohr, Associate Director Investor Relations, UCB Group
T +32.2.559.9264, Mareike.firstname.lastname@example.org
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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