Novartis receives approval in EU for Xolair® to treat children age 6
to 11 years suffering from seve
(Thomson Reuters ONE) - Corporate news announcement processed and transmitted by Hugin AS.The issuer is solely responsible for the content of this announcement. ------------------------------------------------------------------------------------ * Landmark study shows Xolair reduces asthma attacks by 50 percent at one year[1] with a good overall safety and tolerability profile in children age 6 to 11 years[2],[3],[4] * Severe asthma is uncontrolled in over 50 percent of young patients[5], often leading to hospitalization[5], missed school days[6] and need for oral corticosteroids[5] * Approved as add-on therapy, Xolair offers a new treatment approach to nearly 35,000 children in the EU with uncontrolled severe persistent allergic asthma[7]Basel, 24 August, 2009 - Novartis announced today that the EuropeanCommission (EC) has approved Xolair® (omalizumab) as add-on therapyfor severe persistent allergic asthma in children age 6 to 11 years.Xolair is the only approved therapy that targets an underlyingmechanism of asthma and is already approved for use in patients aged12 years and older.Asthma is a chronic lung disease, characterized by recurrent attacksof breathlessness, that is estimated to affect 10 percent of childrenin Europe[8]. It is also the most common cause of schoolabsenteeism[6] and often leads to the need for oral corticosteroiduse in children[5]. Despite conventional therapy, severe asthmaremains uncontrolled in more than 50 percent of children with thiscondition[5]."When a chronic and serious disease like asthma affects children, itcan have life-changing and even life-threatening consequences," saidJoe Jimenez, CEO of the Novartis Pharmaceuticals Division. "This ECapproval of Xolair offers young asthma patients new hope against thisdisease, in line with the Novartis commitment to develop innovativerespiratory health solutions that meet patients' and physicians'needs."EC approval was based in part on a landmark study, presented at theEuropean Respiratory Society Annual Congress in 2008, showing thatXolair reduced asthma attacks by 34 percent after 24 weeks oftreatment[2] and provided an overall reduction of 50 percent at oneyear in patients age 6 to 11 years[1]. Xolair also demonstrated agood overall safety and tolerability profile, consistent with thatobserved in the adult and adolescent population[6].In another study, Xolair, when used in children age 6 to 11, wasshown to significantly reduce the need for oral corticosteroids[9].Children taking Xolair also missed 46 percent fewer school days[9].Xolair, a humanized monoclonal antibody, is a unique treatment whichblocks the action of immunoglobulin E (IgE), an antibody involved inthe underlying mechanism of allergic asthma. By targeting IgE, Xolaircan prevent the onset of debilitating symptoms, such as shortness ofbreath and wheezing, in severely affected patients. Xolair wasapproved as add-on therapy in the EU in 2005 for patients 12 yearsand older with severe persistent allergic asthma. Xolair is currentlyapproved in 63 countries and has been used to treat more than 62,000patients.DisclaimerThe foregoing release contains forward-looking statements that can beidentified by terminology such as "can," "hope," "commitment," orsimilar expressions, or by express or implied discussions regardingpotential future revenues from Xolair. You should not place unduereliance on these statements. Such forward-looking statements reflectthe current views of management regarding future events, and involveknown and unknown risks, uncertainties and other factors that maycause actual results with Xolair to be materially different from anyfuture results, performance or achievements expressed or implied bysuch statements. There can be no guarantee that Xolair will achieveany particular levels of revenue in the future. In particular,management's expectations regarding Xolair could be affected by,among other things, unexpected regulatory actions or delays orgovernment regulation generally; unexpected clinical trial results,including unexpected new clinical data and unexpected additionalanalysis of existing clinical data; the company's ability to obtainor maintain patent or other proprietary intellectual propertyprotection; competition in general; government, industry and generalpublic pricing pressures; the impact that the foregoing factors couldhave on the values attributed to the Novartis Group's assets andliabilities as recorded in the Group's consolidated balance sheet,and other risks and factors referred to in Novartis AG's current Form20-F on file with the US Securities and Exchange Commission. Shouldone or more of these risks or uncertainties materialize, or shouldunderlying assumptions prove incorrect, actual results may varymaterially from those anticipated, believed, estimated or expected.Novartis is providing the information in this press release as ofthis date and does not undertake any obligation to update anyforward-looking statements contained in this press release as aresult of new information, future events or otherwise.About NovartisNovartis provides healthcare solutions that address the evolvingneeds of patients and societies. Focused solely on healthcare,Novartis offers a diversified portfolio to best meet these needs:innovative medicines, cost-saving generic pharmaceuticals, preventivevaccines, diagnostic tools and consumer health products. Novartis isthe only company with leading positions in each of these areas. In2008, the Group's continuing operations achieved net sales of USD41.5 billion and net income of USD 8.2 billion. Approximately USD 7.2billion was invested in R&D activities throughout the Group.Headquartered in Basel, Switzerland, Novartis Group companies employapproximately 99,000 full-time-equivalent associates and operate inmore than 140 countries around the world. For more information,please visit http://www.novartis.com.References[1] EU summary of product characteristics (SmPC) for XOLAIR (August2009).[2] Kulus M, Bridges T, Fowler Taylor A, et al. A randomizedcontrolled study of omalizumab in children with moderate-to-severepersistent allergic asthma. Poster presented at the 18th EuropeanRespiratory Society Congress, October 4-8 2008, Berlin, Germany.[3] Milgrom H, Wasserman RL, Fowler-Taylor A, et al. Add-onomalizumab significantly reduces exacerbation rates in children withinadequately controlled moderate-to-severe allergic (IgE-mediated)asthma. Poster presented at American Thoracic Society (ATS)International Conference, San Diego, California, USA. May 15-20,2009.[4] Milgrom H, Fink J, Fowler-Taylor A, et al. Safety of omalizumabin children with inadequately controlled moderate-to-severe allergic(IgE-mediated) asthma. Poster presented at American Thoracic Society(ATS) International Conference, San Diego, California, USA. May15-20, 2009.[5] Chipps BE, Szefler SJ, Simons FE, et al. Demographic and clinicalcharacteristics of children and adolescents with severe ordifficult-to-treat asthma. J Allergy Clin Immunol 2007;119:1156-63.[6] Chipps BE. Asthma in infants and children. Clin Cornerstone2008;8:44-61.[7] Data on file: Novartis Quantitative Research based on feedbackfrom 300 Paediatricians in EU.[8] http://www.euro.who.int/childhealthenv/Risks/AsthmaTop (accessed3 August 2009).[9] Milgrom H, Berger W, Nayak A, et al. Treatment of childhoodasthma with anti-immunoglobulin E antibody (omalizumab). Pediatrics2001;108;2;1-10. # # #Novartis Media RelationsCentral media line : +41 61 324 e-mail: media.relations(at)novartis.com2200Eric Althoff Rebecca Fisher-PollardNovartis Global Media Relations Novartis Pharma Communications+41 61 324 7999 (direct) +41 61 324 9166+41 79 593 4202 (mobile) +41 79 426 4684eric.althoff(at)novartis.com Rebecca.fisher-pollard(at)novartis.comNovartis Investor RelationsCentral phone: +41 61 324 7944Ruth Metzler-Arnold +41 61 324 North America: 9980Pierre-Michel +41 61 324 Richard Jarvis +1 212 830Bringer 1065 2433John Gilardi +41 61 324 Jill Pozarek +1 212 830 3018 2445Thomas Hungerbuehler +41 61 324 Edwin Valeriano +1 212 830 8425 2456Isabella Zinck +41 61 324 7188e-mail: e-mail:investor.relations(at)novartis.com investor.relations(at)novartis.comhttp://hugin.info/134323/R/1336542/318129.pdf --- End of Message ---Novartis International AGPosfach Basel WKN: 904278; ISIN: CH0012005267; Index: SLCI, SMI, SPI, SLIFE;Listed: Main Market in SIX Swiss Exchange, ZLS in BX Berne eXchange;
Datum: 24.08.2009 - 07:15 Uhr
Sprache: Deutsch
News-ID 4983
Anzahl Zeichen: 0
contact information:
Town:
London
Kategorie:
Business News
Diese Pressemitteilung wurde bisher 369 mal aufgerufen.
Die Pressemitteilung mit dem Titel:
"Novartis receives approval in EU for Xolair® to treat children age 6
to 11 years suffering from seve"
steht unter der journalistisch-redaktionellen Verantwortung von
Novartis International AG (Nachricht senden)
Beachten Sie bitte die weiteren Informationen zum Haftungsauschluß (gemäß TMG - TeleMedianGesetz) und dem Datenschutz (gemäß der DSGVO).
