UCB, Inc. Submits New Drug Application to FDA for Xyzal(R)

    ATLANTA, July 27 /PRNewswire/ -- UCB, Inc. announced today the
 submission of a New Drug Application (NDA) to the United States Food and
 Drug Administration (FDA) for the approval of Xyzal(R) (levocetirizine
 dihydrochloride), a new prescription antihistamine for treatment of allergy
 symptoms.
     If approved, Xyzal(R) will offer U.S. physicians who treat allergy
 patients a new option to control their allergy symptoms. Xyzal(R) is
 already available in many countries around the world. UCB requested as part
 of the FDA application, the following indications: Seasonal Allergic
 Rhinitis, Perennial Allergic Rhinitis, and Chronic Idiopathic Urticaria.
     "The NDA submission for Xyzal(R) is an alternative for U.S. physicians
 seeking an effective prescription treatment for patients that do not
 experience relief with existing medicines," said Roch Doliveux, CEO and
 chairman of UCB's Executive Committee. "UCB is committed to helping meet
 unmet medical needs for patients with allergy symptoms that negatively
 impact their quality of life."
     "Allergic Rhinitis affects upwards of 40 million people in the United
 States. Xyzal(R), when approved and available from UCB, will represent
 another option for many sufferers whose allergy symptoms are uncontrolled
 by current available therapies," said Dr. Sheldon Spector, an allergist and
 Clinical Professor of Medicine, University of California at Los Angeles
 (UCLA) School of Medicine, Los Angeles, California.
     Only an allergist can properly test for the specific triggers that are
 the cause of a patient's allergy symptoms. Patients with allergy symptoms
 should see their allergist to identify the triggers that are affecting them
 to aid in the development of an effective treatment plan.
     About Xyzal(R)
     UCB recently submitted a New Drug Application (NDA) for Xyzal(R)
 (levocetirizine dihydrochloride), which UCB believes demonstrates safety
 and effectiveness as supported by clinical trials. Xyzal(R) is intended for
 use as a once-daily antihistamine for which UCB has requested the
 indications: symptomatic treatment of Seasonal Allergic Rhinitis, Perennial
 Allergic Rhinitis, and Chronic Idiopathic Urticaria in adults and children
 six years of age and older.
     Xyzal(R) was first launched in Europe in 2001 and is currently marketed
 in 49 countries around the world.
     Safety Profile
     In the U.S. application, it was reported that the most common (greater
 than or equal to 2%) adverse events in patients aged 12 years and older
 that occurred more frequently on Xyzal(R) than placebo were
 nasopharyngitis, somnolence, fatigue, and dry mouth. In children 6 to 12
 years old, pyrexia, cough, somnolence, and epistaxis were more commonly
 reported. Most adverse events were considered mild to moderate.
     About Allergic Conditions
     Many people suffer from the symptoms associated with common allergic
 conditions. The immune system of allergy sufferers over-reacts to something
 in the environment. This can lead to symptoms that affect their respiratory
 system, eyes, or skin. Estimates from a skin test survey suggest that
 allergies affect as many as 40 to 50 million people in the United States --
 more than 20 percent of the U.S. population.
     Seasonal Allergic Rhinitis (SAR), commonly referred to as "hay fever"
 or "outdoor allergies," is the most common form of allergic rhinitis. By
 definition, SAR includes allergies to seasonal pollens like grass, trees,
 fungal molds, and weeds. Perennial Allergic Rhinitis (PAR) is sometimes
 referred to as "year round" or "indoor allergies" and is characterized by
 allergies that last longer than four weeks. House dust mites, animal
 dander, and mold most commonly trigger PAR. Chronic Idiopathic Urticaria
 (CIU) is most commonly known as "hives of unknown origin" and is defined as
 the occurrence of daily, or almost daily, wheals and itching for at least
 six weeks with no obvious causes.
     About UCB
     UCB (www.ucb-group.com) is a leading global biopharmaceutical company
 dedicated to the research, development and commercialization 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 8,500 people in 40 countries, UCB
 achieved revenues of euro 2.3 billion in 2005. UCB is listed on the
 Euronext Brussels Exchange with a market capitalization of approximately
 euro 6.0 billion. Worldwide headquarters are located in Brussels, Belgium,
 and U.S. headquarters are located in Atlanta, Georgia.
     Forward-Looking Statement
     This news release contains forward-looking statements that involve
 risks and uncertainties, including statements with respect to the safety,
 efficacy and potential benefits of levocetirizine dihydrochloride, the
 development and commercialization of levocetirizine dihydrochloride. Among
 the factors that could cause actual results to differ materially from those
 indicated by such forward-looking statements are: the results of research,
 development and clinical trials; the timing and success of submission,
 acceptance, and approval of regulatory filings; the time and resources UCB
 devotes to the development and commercialization of levocetirizine
 dihydrochloride and the scope of UCB's patents and the patents of others.
 In addition, the statements in this press release represent UCB's
 expectations and beliefs as of the date of this press release. UCB
 anticipates that subsequent events and developments may cause these
 expectations and beliefs to change. However, while UCB may elect to update
 these forward-looking statements at some point in the future, it
 specifically disclaims any obligation to do so. These forward-looking
 statements should not be relied upon as representing UCB's expectations or
 beliefs as of any date subsequent to the date of this press release.
     Inquiries, please contact:
     Investor Relations
     Jean-Christophe Donck, UCB
     Phone: +32.2.559.9346
     E-mail: jc.donck@ucb-group.com
 
     U.S. Media
     Lisa Garman                              Anne Kirby, UCB
     Phone: +1.770.970.8569                   Phone: +1.770.970.2706
     E-mail: lisa.garman@ucb-group.com        anne.kirby@ucb-group.com
 
 
     (i) http://www.aaaai.org/media/resources/media_kit/allergy_statistics.stm;
         American Academy of Allergy, Asthma & Immunology, site accessed on
         July 24, 2006
 
 
     X301-0706
 
 

SOURCE UCB, Inc.