Novartis investigational bronchodilator QAB149 improves lung function
and reduces breathlessness com
(Thomson Reuters ONE) - Corporate news announcement processed and transmitted by Hugin AS.The issuer is solely responsible for the content of this announcement. ------------------------------------------------------------------------------------ * New data show a higher proportion of patients treated with QAB149 achieved clinically relevant improvements in symptoms of breathlessness compared to tiotropium[1] * Patients taking QAB149 experienced 20 percent more days free of 'relief' medication, used to treat acute episodes of severe breathlessness, compared to tiotropium[2] * The Phase III data reinforce that once-daily QAB149 combines relevant 24-hour bronchodilation[3],[4] with an onset of action within five minutes[5]Basel, September 15, 2009 - Novartis announced today results fromPhase III trials showing QAB149 (indacaterol), an investigationalonce-daily bronchodilator for chronic obstructive pulmonary disease(COPD), significantly improves lung function[3] and provides asignificant reduction in breathlessness[1] compared to tiotropium, acurrent treatment option. The data were presented this week at theEuropean Respiratory Society (ERS) 2009 Annual Congress in Vienna,and build on those presented at the American Thoracic Society (ATS)Annual Meeting earlier this year."QAB149 has the potential to be recognized as the best bronchodilatorfor COPD by providing patients with significantly greater lungfunction improvement and reductions in breathlessness compared toother bronchodilators," said Trevor Mundel, MD, Global Head ofDevelopment at Novartis Pharma AG. "We also plan for QAB149 to formthe foundation of a new portfolio of products, designed to improvepatients' respiratory health."At 12 weeks of treatment, QAB149 150 µg and 300 µg improved troughFEV1[§], a key measure of lung function, by 50 ml and 40 mlrespectively over tiotropium 18 µg (p<=0.01)[3]. New data show atweek 26, that patients on QAB149 300 µg continued to show greaterimprovement in trough FEV1 than tiotropium (p<0.05)[3].Further new data shows that a higher proportion of patients treatedwith QAB149 achieved a significant clinically relevant improvement intheir symptoms of breathlessness compared to tiotropium[1]. Patientson QAB149 also had a highly significant greater than 20 percentincrease in days during which no 'relief' medication, therapies usedto treat acute episodes of severe breathlessness, was requiredcompared to patients treated with tiotropium[2].If approved, QAB149 would become the first once-daily bronchodilatorto combine clinically relevant 24-hour bronchodilation[3],[4] withonset of action within five minutes[5]. QAB149 is currentlyundergoing regulatory review in the European Union, the United Statesand other countries around the world for the treatment of COPD."As most COPD patients want to remain active, we need new therapyoptions that alleviate some of the lifestyle compromises patients areforced to make due to their COPD," said Professor Ronald Dahl,University Hospital of Aarhus, Denmark. "These indacaterol data ineffect mean that the improvements in lung function are accompanied byimportant quality-of-life improvements that our patients need."Data presented on all evaluated doses of QAB149 highlights a goodoverall safety and tolerability profile[6],[7]. The most commonadverse drug reactions were nasopharyngitis, cough, upper respiratorytract infection, and headache. These were mild or moderate in thevast majority of cases and became less frequent if treatment wascontinued.COPD is a progressive, life-threatening respiratory disease[8] thataffects 210 million people worldwide[9]. Commonly caused by cigarettesmoke and other harmful fumes, COPD is characterized by a persistentobstruction of airflow in the lungs, resulting in breathlessness[8].According to the World Health Organization, COPD is currentlyprojected to become the third leading cause of death worldwide by2030[10]. Bronchodilators are a group of drugs that widen the airwaysin the lungs. While incurable, COPD is manageable and improvingairflow with the use of long-acting bronchodilators is central tosymptomatic relief[11].DisclaimerThe foregoing release contains forward-looking statements that can beidentified by terminology such as "potential," "plan," "designed to,""would," "projected," or similar expressions, or by express orimplied discussions regarding potential marketing approvals forQAB149 (indacaterol) or of a potential Novartis portfolio ofrespiratory products or regarding potential future revenues from suchproducts. You should not place undue reliance on these statements.Such forward-looking statements reflect the current views ofmanagement regarding future events, and involve known and unknownrisks, uncertainties and other factors that may cause actual resultswith QAB149 to be materially different from any future results,performance or achievements expressed or implied by such statements.There can be no guarantee that QAB149 or any other potentialcomponents of a Novartis portfolio of respiratory products will beapproved for sale in any market. Nor can there be any guarantee thatsuch products will achieve any particular levels of revenue in thefuture. In particular, management's expectations regarding suchproducts could be affected by, among other things, unexpectedregulatory actions or delays or government regulation generally;unexpected clinical trial results, including unexpected new clinicaldata and unexpected additional analysis of existing clinical data;competition in general; government, industry and general publicpricing pressures; the company's ability to obtain or maintain patentor other proprietary intellectual property protection; the impactthat the foregoing factors could have on the values attributed to theNovartis Group's assets and liabilities as recorded in the Group'sconsolidated balance sheet, and other risks and factors referred toin Novartis AG's current Form 20-F on file with the US Securities andExchange Commission. Should one or more of these risks oruncertainties materialize, or should underlying assumptions proveincorrect, actual results may vary materially from those anticipated,believed, estimated or expected. Novartis is providing theinformation in this press release as of this date and does notundertake any obligation to update any forward-looking statementscontained in this press release as a result 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] 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.[2] 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. Poster accepted for presentation atthe European Respiratory Society (ERS) 2009 Annual Congress inVienna, Austria, 12-16 September 2009.[3] 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. Poster accepted for presentation at theEuropean Respiratory Society (ERS) 2009 Annual Congress in Vienna,Austria, 12-16 September 2009.[4] 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.[5] 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.[6] 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.[7] 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.[8] NHBLI. What is COPD?http://www.nhlbi.nih.gov/health/dci/Diseases/Copd/Copd_WhatIs.html(accessed 14 September 2009).[9] World Health Organization. Factsheet No 315 Chronic obstructivepulmonary disease (COPD).http://www.who.int/mediacentre/factsheets/fs315/en/index.html(accessed 14 September 2009).[10] 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(accessed 14 September 2009).[11] Global Initiative for Chronic Obstructive Pulmonary LungDisease. Global Strategy for the Diagnosis, Management, andPrevention of Chronic Obstructive Pulmonary Lung Disease. Updated2007.[§] Forced expiratory volume in the first second # # #Novartis Media RelationsCentral media line : +41 61 324 e-mail:2200 media.relations(at)novartis.comEric Althoff Rebecca Fisher-PollardNovartis Global Media Novartis Pharma CommunicationsRelations +41 61 324 91 66+41 61 324 7999 (direct) +41 79 426 46 84+41 79 593 4202 (mobile) rebecca.fisher-pollard(at)novartis.comeric.althoff(at)novartis.comNovartis Investor RelationsCentral phone: +41 61 324 7944Ruth +41 61 324 9980 North America:Metzler-ArnoldPierre-Michel +41 61 324 Richard Jarvis +1 212 830Bringer 1065 2433John Gilardi +41 61 324 3018 Jill Pozarek +1 212 830 2445Thomas +41 61 324 8425 Edwin Valeriano +1 212 830Hungerbuehler 2456Isabella Zinck +41 61 324 7188e-mail: e-mail:investor.relations(at)novartis.com investor.relations(at)novartis.comhttp://hugin.info/134323/R/1341238/320751.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: 15.09.2009 - 07:00 Uhr
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