FDA approves XYZAL(R) tablets for the treatment of seasonal and year
round allergies, and chronic urticaria
New once-daily prescription antihistamine for rapid and long-lasting
symptomatic relief
to millions of allergy sufferers
Brussels (Belgium) and Paris (France), May 29, 2007 at 7:00 PM (CET)
- UCB and sanofi-aventis announced today that the U.S. Food and Drug
Administration (FDA) has approved XYZAL(R) (levocetirizine
dihydrochloride), a new once-daily prescription antihistamine that
delivers a rapid and long-lasting effect for the relief of symptoms
associated with seasonal and perennial allergic rhinitis and
treatment of uncomplicated skin manifestations of chronic idiopathic
urticaria in adults and children six years of age and older.
"With allergies on the rise and longer-lasting allergy seasons,
patients desire a fast and long-acting treatment," said Michael S.
Blaiss, Clinical Professor of Pediatrics and Medicine at the
University of Tennessee Health Science Center in Memphis, Tennessee.
"XYZAL(R) is a new treatment option in today's more challenging
allergy environment."
UCB filed the new drug application (NDA) with FDA in July 2006 and
has extensively researched XYZAL(R) in numerous clinical trials.
Studies in allergic rhinitis patients demonstrate XYZAL(R)
significantly reduces the symptoms of sneezing, itchy nose, runny
nose, and itchy eyes. Studies in chronic idiopathic urticaria
patients show XYZAL(R) significantly reduces the severity of itching
and the number and size of wheals.
In September 2006, UCB and sanofi-aventis entered into an agreement
to launch and co-market XYZAL(R) in the U.S. UCB and sanofi-aventis
have a long history in the allergy treatment arena and are committed
to advancing treatment for allergy sufferers and helping meet unmet
medical needs for patients with chronic allergy symptoms. XYZAL(R)
once-daily tablets are expected to be available during the 2007 fall
allergy season.
"I am very pleased to have sanofi-aventis as our partner in bringing
XYZAL(R) to the U.S. market," said UCB's U.S. President, Fabrice
Egros. "The approval of XYZAL(R) will offer an alternative for U.S.
physicians seeking a new prescription treatment option for patients.
We are confident that the attributes of XYZAL(R), along with our
dedicated selling efforts, will result in the successful launch of
this drug in the U.S."
"We are very pleased about the FDA approval of XYZAL(R) and our
partnership with UCB," said Brent Ragans, Vice President, Specialty
Markets, sanofi-aventis. "Building upon our long history in the
allergy treatment arena, this opportunity allows us to continue our
leadership position in this field and demonstrate our commitment to
providing treatment advances for the millions of allergy sufferers in
the U.S."
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 a survey, entitled
Allergies in America, 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, 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 "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 XYZAL(R)
Indications and Important Safety Information
XYZAL is indicated for the relief of symptoms associated with
allergic rhinitis (seasonal and perennial), and uncomplicated skin
manifestations of chronic idiopathic urticaria in adults and children
6 years of age and older.
In clinical trials, the most common adverse reactions in >=2% of
adult and adolescent patients (12 years and older) taking XYZAL 5 mg
were mild to moderate in intensity and included somnolence (6% vs. 2%
placebo), nasopharyngitis (4% vs. 3% placebo), fatigue (4% vs. 2%
placebo) and dry mouth (2% vs. 1% placebo). 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).
The use of XYZAL is contraindicated in patients with end-stage renal
disease (CLcr <10 mL/min) and in patients undergoing hemodialysis.
XYZAL is also contraindicated in 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 depressants should be avoided because
additional reductions in alertness and additional impairment of CNS
performance may occur.
XYZAL® was first launched in Europe in 2001 and is currently marketed
in over 80 countries around the world. The FDA approval is based
primarily upon the results of eight randomized, placebo-controlled
clinical trials involving over 2,000 patients.
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
over 8,500 people in over 40 countries, UCB achieved revenue of 2.5
billion euro in 2006. UCB is listed on the Euronext Brussels
Exchange. Worldwide headquarters are located in Brussels, Belgium.
About sanofi-aventis
Sanofi-aventis is one of the world leaders in the pharmaceutical
industry, ranking number one in Europe. Backed by a world-class R&D
organisation, sanofi-aventis is developing leading positions in seven
major therapeutic areas: cardiovascular, thrombosis, oncology,
metabolic diseases, central nervous system, internal medicine and
vaccines. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in
New York (NYSE: SNY).
Contacts:
UCB sanofi-aventis
Jean-Christophe Donck Salah Mahyaoui
+32 2 559-9346 + 33 6 73.68.78.88
jc.donck@ucb-group.com salah.mahyaoui@sanofi-aventis.com
Mareike Mohr Richard Vento
+32 2 559-9264 + 33 6 78.79.93.26
mareike.mohr@ucb-group.com richard.vento@sanofi-aventis.com
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 Statements
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 financial 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
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.
For the pdf-version of this press release, please click on the link
below:
