Novartis bronchodilator QAB149 recommended for approval in European
Union to treat patients with chr
(Thomson Reuters ONE) - Corporate news announcement processed and transmitted by Hugin AS.The issuer is solely responsible for the content of this announcement. ------------------------------------------------------------------------------------ * QAB149 is set to become the first COPD therapy in the EU that combines 24-hour bronchodilation[1],[2] from a once-daily dose with onset of action within five minutes[3] * A Phase III study vs. tiotropium showed significant lung function benefit[1], improvements in COPD symptoms[4] and significantly more days free of 'relief' medication use[5] * COPD affects 210 million people globally[6], up to 82 million in Europe[7],[8], and is projected to become the third leading cause of death worldwide[9]Basel, September 25, 2009 - Novartis has received a positive opinionrecommending European Union (EU) approval of QAB149 (indacaterol) formaintenance bronchodilator treatment in adult patients with chronicobstructive pulmonary disease (COPD). When approved, QAB149 and itsdevice, Concept-1, will be known as Onbrez® Breezhaler®[§]."QAB149 has the potential to be recognized as an important once-dailyCOPD treatment with a rapid onset of action," said Trevor Mundel, MD,Global Head of Development at Novartis Pharma AG. "QAB149 providesCOPD patients with greater lung function improvements and reductionsin breathlessness compared to other bronchodilators. On approval, ourplans are for QAB149 to form the foundation of a new portfolio ofpotential products designed to improve patients' respiratory health."The positive opinion for two dose strengths of QAB149, 150 mcg and300 mcg, has been issued by the Committee for Medicinal Products forHuman Use (CHMP), the scientific committee of the European MedicinesAgency (EMEA). The European Commission generally follows therecommendations of the CHMP and delivers its final decision withinthree months.QAB149 is currently undergoing regulatory review in the UnitedStates, where the regulatory submission was filed in late 2008.Results from pivotal Phase III trials, presented recently at theEuropean Respiratory Society (ERS) 2009 Annual Congress in Vienna,showed QAB149 significantly improved lung function[1] and providedclinically relevant improvement in symptoms of breathlessness[4]compared to tiotropium, a current treatment option. Further datashowed QAB149 provided a greater than 20 percent increase in daysduring which no 'relief' medication was required[5], compared totiotropium. Relief medication is used to treat acute episodes ofsevere breathlessness.COPD is a progressive, life-threatening respiratory disease[10] thataffects 210 million people worldwide[6], and up to 82 million inEurope[7],[8]. Commonly caused by cigarette smoke and other harmfulfumes, COPD is characterized by a persistent obstruction of airflowin the lungs, resulting in breathlessness[10]. According to the WorldHealth Organization, COPD is currently projected to become the thirdleading cause of death worldwide by 2030[9]. Bronchodilators are agroup of drugs that widen the airways in the lungs. While incurable,COPD is manageable, and improving airflow with the use of long-actingbronchodilators is central to symptomatic relief[11].Data on all evaluated doses of QAB149 show a good overall safety andtolerability profile[12],[13]. The most common adverse drug reactionswere nasopharyngitis, cough, upper respiratory tract infection, andheadache. These were mild or moderate in the vast majority of casesand became less frequent when treatment was continued.DisclaimerThe foregoing release contains forward-looking statements that can beidentified by terminology such as "recommended for approval," "set tobecome," "projected," "recommending . approval," "will," "potential,""plans," "designed to," "projected," or similar expressions, or byexpress or implied discussions regarding potential marketingapprovals for QAB149 (indacaterol) or of a potential Novartisportfolio of respiratory products or regarding potential futurerevenues from such products. You should not place undue reliance onthese statements. Such forward-looking statements reflect thecurrent views of management regarding future events, and involveknown and unknown risks, uncertainties and other factors that maycause actual results to be materially different from any futureresults, performance or achievements expressed or implied by suchstatements. There can be no guarantee that QAB149 or any otherpotential components of a Novartis portfolio of respiratory productswill be approved for sale in any market. Nor can there be anyguarantee that such products will achieve any particular levels ofrevenue in the future. In particular, management's expectationsregarding such products could be affected by, among other things,unexpected regulatory actions or delays or government regulationgenerally; unexpected clinical trial results, including unexpectednew clinical data and unexpected additional analysis of existingclinical data; competition in general; government, industry andgeneral public pricing pressures; the company's ability to obtain ormaintain patent or other proprietary intellectual propertyprotection; the impact that the foregoing factors could have on thevalues attributed to the Novartis Group's assets and liabilities asrecorded in the Group's consolidated balance sheet, and other risksand factors referred to in Novartis AG's current Form 20-F on filewith the US Securities and Exchange Commission. Should one or more ofthese risks or uncertainties materialize, or should underlyingassumptions prove incorrect, actual results may vary materially fromthose anticipated, believed, estimated or expected. Novartis isproviding the information in this press release as of this date anddoes not undertake any obligation to update any forward-lookingstatements contained in this press release as a result of newinformation, 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] Fogarty C, Hébert J, Iqbal A et al. QAB149 once-daily provideseffective 24-h bronchodilation in COPD patients: a 26-week evaluationvs placebo and tiotropium. Abstract accepted for presentation at theEuropean Respiratory Society (ERS) 2009 Annual Congress in Vienna,Austria, 12-16 September 2009.[2] Dahl R, Kolman P, Jack D et al. Bronchodilator therapy withQAB149 once-daily in COPD: a 52-week comparison with formoterol.Abstract accepted for presentation at the European RespiratorySociety (ERS) 2009 Annual Congress in Vienna, Austria, 12-16September 2009.[3] Balint B, Watz H, Amos C et al. Fast onset of bronchodilationwith QAB149 in patients with COPD. Abstract accepted for presentationat the European Respiratory Society (ERS) 2009 Annual Congress inVienna, Austria, 12-16 September 2009.[4] Mahler DA, Palange P, Iqbal A et al. QAB149 once-daily improvesdyspnoea in COPD patients: a 26-week placebo-controlled study withopen-label tiotropium comparison. Abstract accepted for presentationat the European Respiratory Society (ERS) 2009 Annual Congress inVienna, Austria, 12-16 September 2009.[5] Lötvall J, Cosio BG, Iqbal A et al. QAB149 once-daily improvesday and night-time symptom control in COPD patients: a 26-week studyversus placebo and tiotropium. Abstract and poster accepted forpresentation at the European Respiratory Society (ERS) 2009 AnnualCongress in Vienna, Austria, 12-16 September 2009.[6] World Health Organization. Factsheet No 315 Chronic obstructivepulmonary disease (COPD).http://www.who.int/mediacentre/factsheets/fs315/en/index.html(accessed 14 September 2009).[7] Halbert RJ, Isonaka S, George D et al. Interpreting COPDPrevalence Estimates. What Is the True Burden of Disease? Chest2003;123:1684-1692.[8] Lanzieri G. Population in Europe 2007: first results. Eurostat.Statistics in Focus 81/2008, Population and social conditions.[9] World Health Organization. COPD predicted to be third leadingcause of death in 2030.http://www.who.int/gard/news_events/World_Health_Statistics_2008/en/index.html (accessed14 September 2009).[10] NHBLI. What is COPD?http://www.nhlbi.nih.gov/health/dci/Diseases/Copd/Copd_WhatIs.html (accessed14 September 2009).[11] Global Initiative for Chronic Obstructive Pulmonary LungDisease. Global Strategy for the Diagnosis, Management, andPrevention of Chronic Obstructive Pulmonary Lung Disease. Updated2007.[12] Worth H, Kleerup E, Iqbal A et al. Safety and tolerability ofQAB149 once-daily in COPD patients versus placebo and tiotropium: a26-week study. Abstract accepted for presentation at the EuropeanRespiratory Society (ERS) 2009 Annual Congress in Vienna, Austria,12-16 September 2009.[13] Chung KF, Kornmann O, Jack D et al. Safety and tolerability ofindacaterol over 52 weeks of treatment in COPD. Abstract accepted forpresentation at the European Respiratory Society (ERS) 2009 AnnualCongress in Vienna, Austria, 12-16 September 2009.[§] Onbrez® Breezhaler® are the names for indacaterol and itsdelivery device, Concept1, which are pending approval in the EU. # # #Novartis Media RelationsCentral media line : +41 61 3242200Eric Althoff Rebecca Fisher-PollardNovartis Global Media Relations Novartis Pharma Communications+41 61 324 7999 (direct) +41 61 324 91 66+41 79 593 4202 (mobile) +41 79 426 46 84eric.althoff(at)novartis.com rebecca.fisher-pollard(at)novartis.come-mail:media.relations(at)novartis.comNovartis Investor RelationsCentral phone: +41 61 324 7944Ruth +41 61 324 9980 North America:Metzler-ArnoldPierre-Michel +41 61 324 1065 Richard Jarvis +1 212 830Bringer 2433John Gilardi +41 61 324 3018 Jill Pozarek +1 212 830 2445Thomas +41 61 324 Edwin Valeriano +1 212 830Hungerbuehler 8425 2456Isabella Zinck +41 61 324 7188e-mail: e-mail:investor.relations(at)novartis.com investor.relations(at)novartis.comhttp://hugin.info/134323/R/1343682/321915.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: 25.09.2009 - 17:20 Uhr
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