UCB Profile
UCB S.A. operates as a biopharmaceutical company that focuses on three therapeutic areas – the central nervous system (CNS), inflammation and immunology (including allergy), and oncology in Belgium. The company operates in approximately 40 countries worldwide. Its major global markets include the U.S., Europe and Japan.
UCB’s major pharmaceutical products include:
Keppra (levetiracetam)
Keppra is an antiepileptic, which significantly reduces the frequency of epileptic attacks. Keppra is indicated as an add-on therapy for partial onset seizures with or without secondary generalized seizures for epilepsy patients aged approximately 16 years. Keppra was filed in the U.S. in December 2004 and in Europe in March 2005, as an application for a new intravenous formulation. In the fourth quarter of 2004, the company also filed a paediatric indication of Keppra (for patients aged 4-16) in the U.S. and Europe.
Xyzal (levocetirizine) and Zyrtec (cetirizine)
Xyzal (levocetirizine) and Zyrtec (cetirizine) are antiallergics prescribed for seasonal rhinitis, perennial rhinitis and chronic idiopathic urticaria. A Phase III EPAAC study (Early Prevention of Asthma in Atopic Children) is underway to test the hypothesis that Xyzal can delay the onset of asthma in atopic children.
Xyrem
Xyrem is the FDA-approved medication for the treatment of cataplexy (sudden loss of control over voluntary muscle movement) associated with narcolepsy.
Nootropil (piracetam)
Nootropil is a cerebral function regulator and first in the class of ‘nootropic’ agents.
Atarax
Atarax (hydroxyzine) is a non-benzodiazepinic tranquilliser.
Lortab
Lortab (hydrocodone-paracetamol), an analgesic, which reduces sensitivity to most types of pain.
Tussionex
Tussionex is the 12-hour hydrocodone-based prescription syrup for coughs and colds, enabling UCB to offer a range of respiratory therapies.
Metadate CD / Equasym XL
Unique extended-release formulation of the most commonly used treatment of Attention Deficit and Hyper activity Disorder (ADHD). Marketed in the U.S. as Metadate CD, this once-daily methylphenidate has an extended release formulation, enabling children to maintain their attention throughout the school day more effectively, without affecting their appetite or sleep patterns in the evening. The company intends to launch it in Europe in 2005 under the brand name Equasym XL. In February 2005, Equasym XL was approved for marketing and launched in the UK.
Dipentum
Dipentum is a treatment for ulcerative colitis.
Somatostatin-UCB
Somatostatin-UCB is for the treatment of patients suffering from haemorrhaging of the oesophagus and post-operative gastro-intestinal fistulas.
Brivaracetam (UCB34714)
Brivaracetam is a broad-spectrum product in development. Phase II clinical trials including patients with photosensitive epilepsy produced preliminary results suggesting the compound is more potent than Keppra and provides suppression of light-induced electro encephalogram (EEG) abnormalities. Brivaracetam has also demonstrated some preclinical activity in the treatment of neuropathic pain and essential tremor.
Seletracetam (UCB4412)
Seletracetam is a SV2A ligand in development. Seletracetam reduces high-voltage-activated calcium currents, providing UCB with another avenue for tackling the heterogeneous nature of epilepsy. A Phase I clinical trial has indicated that this compound is well tolerated and preclinically even more potent than Keppra.
Attention deficit/hyperactivity disorder (ADHD)
CDP323
CDP323 has potential in tackling the inflammation associated with several major diseases. Preclinical data demonstrates activity in multiple sclerosis, rheumatoid arthritis and asthma. There is additional potential for this product in psoriasis. CDP323 is a smallmolecule inhibitor of alpha-4 integrins. Its mechanism of action is to stop white blood cells migrating to and exacerbating areas of inflammation. As a small molecule, it can be taken orally. CDP323 completed a Phase I multipledose study.
Efletirizine
Efletirizine is a novel antihistamine with a promising onset of action and safety profile.
Rheumatoid arthritis (RA)
Cimzia (CDP870)
The company intends to pursue approval of Cimzia for RA with the hope of providing RA patients with all the advantages of a PEGylated anti-TNF-alpha antibody fragment. It is pursuing the development of a liquid formulation as opposed to a frozen or ‘lyophilized’ format, which has to be reconstituted. The company completed its two pivotal registration studies and started additional profiling Phase III clinical trials.
CDP484
IL-1-beta is a mediator in many inflammatory diseases, including RA. A Phase I study of CDP484 has been completed and it is evaluating the therapeutic opportunity.
Multiple sclerosis (MS) and other diseases
As an integrin antagonist, CDP323 has potential for activity in multiple sclerosis.
CMC544
CMC544, which is being developed in partnership with Wyeth, is an antibody that selectively binds to CD22. CMC544 is a conjugated full-length humanized monoclonal antibody linked to the cytotoxin calicheamicin. CMC544 is in Phase I trials for Non-Hodgkins Lymphoma (NHL).
CDP791
CDP791 selectively blocks the Vascular Endothelial Growth Factor Receptor-2 (VEGFR-2), which promotes blood-vessel growth in solid tumours. The product successfully progressed in Phase I trials and should be entering Phase II in 2005.
Significant Events
UCB SA has entered an agreement with Biogen Idec, Inc. over the development and marketing of a UCB drug candidate known as CDP323. The orally active, small-molecule, alpha4-integrin inhibitor, which is being developed as a treatment for relapsing-remitting multiple sclerosis (MS), is in early-stage clinical trials.
Teva Specialty Pharmaceuticals, the U.S. respiratory therapy unit of Teva Pharmaceutical Industries, Ltd. and UCB SA announced an agreement to co-commercialize Teva's U.S. respiratory medicines. The initial product to be jointly promoted in the U.S. is Teva's ProAirHFA (albuterol sulfate) Inhalation Aerosol. ProAirHFA is a branded hydrofluroalkane (HFA) albuterol sulfate inhaler.
Decode Chemistry Inc. along with deCODE biostructures Inc., has signed a discovery and development agreement with UCB SA. Both deCODE chemistry and deCODE biostructures are based in the United States. Under the terms of the agreement, deCODE and UCB would collaborate on the structure-based discovery of small molecule modulators of undisclosed cytokine targets. The program would focus on integrated structure-based drug design leveraging deCODE's Fragments of Life technology for lead identification and optimization. As the program advances, it may also capitalize on deCODE's expertise in ADMET and PK/PD.
