New prescription allergy treatment XYZAL® (levocetirizine dihydrochloride) now available for fall allergy season in the USA
Brussels, Belgium and Paris, France, October 2, 2007 - 8:00 am CET - UCB and sanofi-aventis announced today that XYZAL®, a new once-daily medication used to treat indoor and outdoor allergies, as well as chronic idiopathic urticaria, is now available by prescription in the USA. XYZAL® is an oral antihistamine that has been shown to provide powerful allergy symptom relief. XYZAL® is approved for use in adults and children 6 years and older.
"Allergy patients need a prescription treatment option that works quickly to relieve their suffering," said Michael S. Blaiss, MD, Clinical Professor of Pediatrics and Medicine at the University of Tennessee Health Science Center in Memphis, Tennessee. "It is important for people living with allergies to work with their physician to develop an appropriate allergy treatment plan that will effectively reduce their symptoms."
According to the Asthma and Allergy Foundation of America (AAFA), 60% of adult patients who were using a prescription medication to treat their seasonal allergies were very interested in finding a new prescription allergy treatment.
A recent survey conducted by Harris Interactive® of 683 seasonal and year-round allergy sufferers revealed that almost three-quarters (74%) of those diagnosed with allergies agreed that they do not feel like themselves when they are suffering from allergies. In addition, 81% of respondents agreed that they have adjusted their lives to deal with their allergies and more than half (53%) of allergy sufferers surveyed agreed that they avoid various activities like being outside, traveling and being social because of their allergies.
Studies in allergic rhinitis patients demonstrated XYZAL® significantly reduced the common symptoms of the disease, including sneezing, itchy nose, runny nose, and itchy eyes. XYZAL® has also been shown to significantly reduce the redness, swelling and itching symptoms associated with hives. In studies with patients exposed to pollen, XYZAL® was shown to relieve allergy symptoms at 60 minutes of administration and efficacy was demonstrated at the end of 24 hours. In clinical trials, XYZAL® was well tolerated.
XYZAL® was approved by the U.S. Food and Drug Administration (FDA) in May 2007. In September 2006, UCB and sanofi-aventis entered into an agreement to launch and co-market XYZAL® in the USA.
XYZAL® is currently marketed in more than 80 countries worldwide, including the European Union. The FDA approval is based primarily upon the results of eight randomized, placebo-controlled clinical trials involving over 2,000 patients.
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, leading to symptoms that affect their respiratory system, eyes, or skin. Estimates from the American Academy of Allergy, Asthma & Immunology (AAAAI) suggest that allergies affect as many as 40 million people in the United States.
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, and weeds, as well as mold. Perennial Allergic Rhinitis (PAR) is sometimes referred to as "year round" or "indoor allergies" and is characterized by allergic symptoms 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 "chronic 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 the Harris Interactive® Survey
A survey was conducted online within the United States between August 16 and August 20, 2007 among 2,475 U.S. adults ages 18+, of whom, 683 have been diagnosed with seasonal and year-round allergies. Of those diagnosed with allergies surveyed, 34% were male and 66% female.
Results were weighted as needed for age, sex, race/ethnicity, education, region and household income to reflect the composition of the U.S. adult population. Propensity score weighting was also used to adjust for respondents' propensity to be online. All sample surveys and polls, whether or not they use probability sampling, are subject to multiple sources of error which are most often not possible to quantify or estimate, including sampling error, coverage error, error associated with nonresponse, error associated with question wording and response options, and post-survey weighting and adjustments. Therefore, Harris Interactive avoids the words "margin of error" as they are misleading. All that can be calculated are different possible sampling errors with different probabilities for pure, unweighted, random samples with 100% response rates. These are only theoretical because no published polls come close to this ideal.
Because the sample is based on those who agreed to be invited to participate in the Harris Interactive online research panel, no estimates of theoretical sampling error can be calculated.
This survey was supported by UCB and sanofi-aventis.
Indications and Important Safety Information
XYZAL® is indicated for the relief of symptoms associated with allergic rhinitis (seasonal and perennial) and the treatment of uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 years of age and older.
The use of XYZAL® is contraindicated in: patients with a known hypersensitivity to levocetirizine or any of the ingredients of XYZAL® or to cetirizine (observed reactions range from urticaria to anaphylaxis); patients with end-stage renal impairment at less than 10 mL/min creatinine clearance or patients undergoing hemodialysis; and pediatric patients aged 6 to 11 years with impaired renal function.
Patients should be cautioned against engaging in hazardous occupations requiring complete mental alertness and motor coordination, such as operating machinery or driving a motor vehicle, after ingestion of XYZAL®. Concurrent use of XYZAL® with alcohol or other central nervous system (CNS) depressants should be avoided because additional reductions in alertness and additional impairment of CNS performance may occur.
In clinical trials, the most common adverse reactions in >=2% of adult and adolescent patients (12 years of age and older) taking XYZAL 2.5 mg, XYZAL 5 mg, or placebo were somnolence (5%, 6%, 2%), nasopharyngitis (6%, 4%, 3%), fatigue (1%, 4%, 2%), dry mouth (3%, 2%, 1%), and pharyngitis (2%, 1%, 1%), respectively.
In clinical trials, the most common adverse reactions in >=2% of pediatric patients (6-12 years of age) taking XYZAL 5 mg included pyrexia (4% vs 2% placebo), cough (3% vs <1% placebo), somnolence (3% vs <1% placebo), and epistaxis (2% vs <1% placebo).
Please visit www.XYZAL.com for full prescribing information.
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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 more than 10,000 people in over 40 countries, UCB achieved revenue of 3.5 billion euro in 2006 on a pro forma basis. UCB is listed on the Euronext Brussels Exchange and owns approx. 88% of the shares of SCHWARZ PHARMA AG. SCHWARZ PHARMA AG (Monheim, Germany) is a member of UCB Group.
Sanofi-aventis, a leading global pharmaceutical company, discovers, develops and distributes therapeutic solutions to improve the lives of everyone. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
UCB Forward-Looking Statement
This news release contains forward-looking statements that involve risks and uncertainties, including statements with respect to the development and commercialization of levocetirizine. 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 and the scope of UCB's patents and the patents of others.
Sanofi-aventis Forward-Looking Statement
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include product development, product potential projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future events, operations, products and services, and statements regarding future performance. Forward-looking statements are generally identified by the words "expects," "anticipates," "believes," "intends," "estimates," "plans" and similar expressions. Although sanofi-aventis' management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of sanofi-aventis, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMEA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such products candidates, the absence of guarantee that the products candidates if approved will be commercially successful, the future approval and commercial success of therapeutic alternatives as well as those discussed or identified in the public filings with the SEC and the AMF made by sanofi-aventis, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in sanofi-aventis' annual report on Form 20-F for the year ended December 31, 2006. Other than as required by applicable law, sanofi-aventis does not undertake any obligation to update or revise any forward-looking information or statements.
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