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UCB: Confidence in the future - Significant Programmes for R&D and Investment for the Year 2004.

18th December 2003 

The UCB Group activity in the second half of the year shows improvements versus the first half of the year. At constant exchange rates, the Group total net results could reach a double digit growth.

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The Board of Directors has approved the Group R&D expenditure budget of a total amount of € 302 million for 2004, compared to an estimate of € 279 million for 2003, an increase of 8%.  Pharma R&D represents an amount of € 244 million and Surface Specialties R&D, € 58 million.   

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In Pharma, the research budget, which will increase by double digit at constant exchange rate, remains focused on its two therapeutic axes: neurology and allergy/asthma.

In neurology, for Keppra, additional resources are devoted to broaden and hasten further development of Keppra in epilepsy and other CNS (Central Nervous System) conditions. Studies aiming to demonstrate the efficacy in monotherapy in epilepsy are ongoing.  Enrolment is faster than expected, leading to submissions to regulatory authorities in 2005 or 2006.  UCB, in addition, has ongoing Keppra development programmes in pediatric epilepsy and in add-on primary generalized seizures with submission foreseen over the next three years.  A large number of patients were involved in phase IV studies confirming the safety of Keppra as adjunctive therapy in epilepsy.  UCB is working to the completion of its phase III programme in Japan.  An oral solution was approved by the FDA in July 2003 and marketing approval is actively pursued in Europe for this formulation.  The development of an intravenous formulation is also ongoing. Based on strong pre-clinical results and positive experiences in clinical studies, a number of proofs of concepts have encouraged UCB to actively explore the efficacy and safety of Keppra in a range of CNS conditions.

UCB 34714 has entered, as planned, phase II clinical development in epilepsy and will be studied in other CNS indications.  Very promising pre-clinical data were presented recently at the Society for Neuroscience meeting in New Orleans and at the American Epilepsy Society meeting in Boston.

UCB 44212, a new compound, is more potent than Keppra in animal models of epilepsy.  It will enter clinical development in 2004 in epilepsy.  

In allergy/asthmaXyzal confirms its superior therapeutic profile as evidenced by several studies such as:
- The XPERT study (Xyzal in Persistent Rhinitis Trial against placebo) was completed beginning 2003.  It is the first study of six months treatment in that pathology and it demonstrated the sustained efficacy of Xyzal over the entire treatment period.
- A study (Professor Day – Canada) completed in 2003 demonstrated Xyzal's fast onset of action and potent activity on rhinitis symptoms versus its key competitor.

In addition, enrolment is better than expected in a major trial in atopic children (EPAAC: Early Prevention of Asthma in Atopic Children).  The objective of this study is to demonstrate the reduction in the development of asthma in atopic children treated with Xyzal.

Efletirizine has completed phase III and UCB is continuing research to find a suitable technology that will allow once a day dosing.  The 5Lipoxygenases programme is continuing for allergic/asthma in the clinic.  

In addition to these important development programmes which will support internal growth, UCB, one of the few midsize companies with global presence, has an ongoing aggressive partnering programme to acquire rights for new molecules.  UCB Pharma entered a European licensing agreement with Watson for the commercialisation of its oxybutynin transdermal patch for the treatment of overactive bladder with symptoms of urge incontinence. Watson Pharmaceuticals has received a positive EU opinion for this transdermal patch.  

Surface Specialties

Surface Specialties is the global leader, at the forefront of industrial coating technologies, and well positioned to develop unique solutions in these markets. It has, for each of its key technology, a global centre of excellence and through this R&D network, it is well positioned for developing with its customers advances in the applications of every major environmental friendly technology such as water-borne, radiation cure and powder. In addition, in the industrial coating segment, regulations accelerate the conversion from solvent-borne to the eco-friendly technologies. 

Recent developments are directed towards radiation curing systems for the automotive market allowing improvement of productivity. For the printing ink market new vehicles based on Radcure technologies are developed and allow ink formulators to simplify and upgrade their product range. Combination of waterborne and Radcure technology opens up new opportunities in wood and plastic coating applications.  Combination of film and coating technologies has resulted in the creation of the NatureFlex (TM) range of compostable filmic packaging materials.

In addition, with the growth of the Asian market, Surface Specialties is reinforcing its development capabilities in this region.

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The investment programmes for 2004 has been fixed at a total of € 165 million, divided as follows: Pharma € 74 million, Surface Specialties € 81 million and non-sectorial € 10 million, compared to € 204 million for the year 2003. Investments in Pharma are mostly realized in connection with constant quality and safety improvements. For Surface Specialties, the major investments are in relation with additional production capacity, the start of the new European facility at Saint-Ghislain (Belgium) and extension in China. 

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In summary, the UCB Group results' trend for 2003 is significantly better than the first half of the year.
The R&D and investment programmes amount to a total of € 467 million for the year 2004 and contribute to UCB's strategy of innovation and global expansion.


Contact 
Arnaud Denis -
Investor Relations Manager
Tel : +32-(0)2-559.92.64
Fax : +32-(0)2-559.95.71 

E-mail : investor-relations@ucb-group.com

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