Healthcare Industry News: S.A.
News Release - February 19, 2008
FDA Approves XYZAL(R) (levocetirizine dihydrochloride) Oral Solution for the Relief of Seasonal and Year Round Allergies and Chronic Idiopathic Urticaria
BRUSSELS, BELGIUM--(Healthcare Sales & Marketing Network)--Feb 19, 2008 Brussels, Belgium and Paris, France - February 19, 2008 at 8:00 am CET - UCB and sanofi-aventiS.A.nounced today that the U.S. Food and Drug Administration (FDA) approved a New Drug Application (NDA) for XYZAL® (levocetirizine dihydrochloride) 0.5 mg/mL oral solution, a prescription antihiS.A.ine indicated for the relief of symptomS.A.sociated with indoor and outdoor allergies, as well as the treatment of chronic idiopathic urticaria. XYZAL® tablets received FDA approval on May 25, 2007 and both formulationS.A.e now approved for use in adultS.A.d children 6 yearS.A.d older."The oral solution of XYZAL® provideS.A.welcome alternative for those patients who have difficulty S.A.lowing or who prefer liquid medication," said Michael S. Blaiss, MD, Clinical Professor of PediatricS.A.d 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® 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.A.d helping meet unmet medical needs for patients with chronic allergy symptoms.
About Allergic Conditions
Many people suffer from the symptomS.A.sociated 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.A.fect as many as 40 million people in the United S.A.es.
S.A.onal allergic rhinitis (SAR), commonly referred to as "hay fever" or "outdoor allergies," is the most common form of allergic rhinitis. By definition, SAR includeS.A.lergies to S.A.onal 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.A.d itching for at least six weeks with no obvious causes.
About XYZAL®
IndicationS.A.d Important Safety Information XYZAL® is indicated for the relief of symptomS.A.sociated with allergic rhinitis (S.A.onal and perennial) and the treatment of uncomplicated skin manifeS.A.ions of chronic idiopathic urticaria in adultS.A.d 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-S.A.e renal impairment at less than 10 mL/min creatinine clearance or patients undergoing hemodialysis; and pediatric patientS.A.ed 6 to 11 years with impaired renal function.
Patients should be cautioned against engaging in hazardous occupations requiring complete mental alertnesS.A.d 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) depreS.A.ts should be avoided because additional reductions in alertnesS.A.d 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 4 to 6 weeks in duration, 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 epiS.A.is (2% vs < 1% placebo).
Full prescribing information for XYZAL® iS.A.ailable at www.XYZAL.com.
Further information
UCB
Antje Witte, Vice-President Corporate Communications & Investor
Relations, UCB Group
T +32.2.559.9414, Antje.witte@ucb-group.com
Eric Miller, Director, U.S. Corporate CommunicationS.A.d Public Relations
T +1 770-970-8569, eric.miller@ucb-group.com
sanofi-aventis
Richard Vento, Corporate Products Communication
Telephone: + 33 1 53 77 43 18
Mobile : + 33 6 78N79 93 26
About UCB
UCB, Brussels, Belgium (www.ucb-group.com) iS.A.global leader in the biopharmaceutical industry dedicated to the reS.A.ch, development and commercialisation of innovative pharmaceutical and biotechnology products in the fields of central nervous system disorders, allergy/respiratory diS.A.es, immune and inflammatory disorderS.A.d oncology. UCB focuses on securing a leading position in severe diS.A.e categories. Employing around 12,000 people in over 40 countries, UCB achieved revenue of 3.5 billion euro in 2006 on a pro forma basis. UCB S.A. is listed on Euronext Brussels. SCHWARZ PHARMA AG (Monheim, Germany) iS.A.member of the UCB Group.
About sanofi-aventis
Sanofi-aventis, a leading global pharmaceutical company, discovers, developS.A.d 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 S.A.ement
This news release contains forward-looking S.A.ements that involve riskS.A.d uncertainties, including S.A.ements 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 S.A.ementS.A.e: the results of reS.A.ch, 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.A.d the patents of others.
Sanofi-aventis Forward-Looking S.A.ements
This press release contains forward-looking S.A.ementS.A. defined in the Private Securities Litigation Reform Act of 1995, aS.A.ended. Forward-looking S.A.ementS.A.e S.A.ements that are not historical facts. These S.A.ements include product development, product potential projectionS.A.d estimateS.A.d their underlying assumptions, S.A.ements regarding plans, objectives, intentionS.A.d expectations with respect to future events, operations, productS.A.d services, and S.A.ements regarding future performance. Forward-looking S.A.ementS.A.e 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 S.A.ementS.A.e reasonable, investorS.A.e cautioned that forward-looking information and S.A.ementS.A.e subject to various riskS.A.d uncertainties, many of which are difficult to predict and generally beyond the control of sanofi-aventis, that could cause actual resultS.A.d developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and S.A.ements. These riskS.A.d uncertainties include among other things, the uncertainties inherent in reS.A.ch 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.A. 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.A. 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 S.A.ement Regarding Forward-Looking S.A.ements" 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 S.A.ements.
Source: UCB
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