BRUSSELS, Belgium, and BRIDGEWATER, N.J., Feb. 19
/PRNewswire-FirstCall/ -- UCB (Euronext: UCB) and sanofi-aventis announced
today that the U.S. Food and Drug Administration (FDA) approved a New Drug
Application (NDA) for XYZAL(R) (levocetirizine dihydrochloride) 0.5 mg/mL
oral solution, a prescription antihistamine indicated for the relief of
symptoms associated with indoor and outdoor allergies, as well as the
treatment of chronic idiopathic urticaria. XYZAL(R) tablets received FDA
approval on May 25, 2007 and both formulations are now approved for use in
adults and children 6 years and older.
"The oral solution of XYZAL(R) provides a welcome alternative for those
patients who have difficulty swallowing or who prefer liquid medication,"
said Michael S. Blaiss, MD, Clinical Professor of Pediatrics and Medicine
at the University of Tennessee Health Science Center in Memphis, Tennessee.
"Both the oral solution and tablets offer patients powerful and
long-lasting allergy relief."
Studies in allergic rhinitis patients demonstrated levocetirizine
significantly reduced the symptoms of sneezing, itchy nose, runny nose, and
itchy eyes. Studies in chronic idiopathic urticaria patients showed
levocetirizine significantly reduced 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.
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 indoor and outdoor 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 XYZAL(R)
Indications and Important Safety Information
XYZAL(R) 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(R) 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(R). Concurrent use of XYZAL(R) 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 > or = 2% of
adult and adolescent patients (12 years of age and older) taking XYZAL 2.5
mg, XYZAL(R) 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 4 to 6 weeks in duration, the most common adverse
reactions in > or = 2% of pediatric patients (6-12 years of age) taking
XYZAL(R) 5 mg included pyrexia (4% vs 2% placebo), cough (3% vs <1%
placebo), somnolence (3% vs <1% placebo) and epistaxis (2% vs <1% placebo).
Full prescribing information for XYZAL(R) is available at
http://www.XYZAL.com.
About UCB
UCB, Brussels, Belgium (http://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.
About sanofi-aventis
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 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 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 labeling 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.
For Further Information, Please Contact:
UCB
Antje Witte, Vice-President, Corporate Communications and Investor
Relations
Phone: +32.2.559.9414,
antje.witte@ucb-group.com
Eric Miller, Director, U.S. Corporate Communications and Public Relations
Phone: 770-970-8569
eric.miller@ucb-group.com
sanofi-aventis
Susan Brooks, US Communications
Phone: 908-981-6566 Mobile: 201-572-4994
Email: Susan.Brooks@sanofi-aventis.com
XYZAL(R) is a trademark of UCB Group of companies.
SOURCE sanofi-aventis
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Related links:
http://www.sanofi-aventis.us
http://www.sanofi-aventis.com http://www.XYZAL.com
http://www.prnewswire.com/comp/232375.html /
CONTACT:
Antje Witte, Vice-President, Corporate
Communications and Investor Relations, +32-2-559-9414,
antje.witte@ucb-group.com, or Eric Miller, Director, U.S.
Corporate Communications and Public Relations, +1-770-970-8569,
eric.miller@ucb-group.com, both of UCB; Susan Brooks, US
Communications, sanofi-aventis, +1-908-981-6566, mobile
+1-201-572-4994, Susan.Brooks@sanofi-aventis.com
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