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
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
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.
Andrea Levin Susan Brooks
UCB, Inc sanofi-aventis
Phone: 770-970-8352 Phone: 908-981-6566
Mobile: 404-483-7329 Mobile : 201-572-4994
Antje Witte Salah Mahyaoui
+32 2 559-9346 + 33 6 126.96.36.199
Mareike Mohr Richard Vento
+32 2 559-9264 + 33 6 188.8.131.52
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.
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Forward-looking statements are statements that are not historical
facts. These statements include product development, product
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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
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