Novartis receives approval in the European Union for Onbrez®
Breezhaler®, a new once-daily bronchodi
(Thomson Reuters ONE) - Corporate news announcement processed and transmitted by Hugin AS.The issuer is solely responsible for the content of this announcement. ------------------------------------------------------------------------------------ * Onbrez® Breezhaler® demonstrated superiority to tiotropium[1], formoterol[2], salmeterol[3]; first new inhaled compound for treatment of COPD in seven years for EU patients * Onbrez Breezhaler is only treatment for COPD to combine 24-hour bronchodilation[1,2,3] from a once-daily dose with rapid onset of action within five minutes[4,5] * 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, December 3, 2009 - Novartis announced today that the EuropeanCommission (EC) has approved Onbrez Breezhaler (QAB149 orindacaterol) in both 150 mcg and 300 mcg doses as a new once-dailymaintenance bronchodilator treatment of airflow obstruction in adultpatients with chronic obstructive pulmonary disease (COPD)."Onbrez Breezhaler has demonstrated greater improvements in lungfunction, breathlessness and quality of life compared to currenttherapies," said Joe Jimenez, CEO of the Novartis PharmaceuticalsDivision. "The EC approval of Onbrez Breezhaler means this new andeffective therapy will soon be available to people in the EU withCOPD and, through better symptom control, will help them to live moreactive and productive lives despite their condition."Onbrez Breezhaler, containing the active ingredient indacaterolmaleate, is the first new inhaled compound for the treatment of COPDto be made available for EU patients in seven years. Additionally, itis the first and only treatment to demonstrate in clinical studiesboth 24-hour bronchodilation[1,2,3] and a rapid onset of actionwithin five minutes of inhalation[4,5].COPD is a progressive, life-threatening respiratory disease[10] thataffects 210 million people worldwide[6], up to 82 million inEurope[7,8], the majority of whom are under the age of 65[11]. COPDimpairs lung function resulting in chronic breathlessness. This leadsto a profound, negative impact on patients' ability to work andsupport families. COPD currently ranks tenth in overall diseaseburden, ahead of asthma and diabetes[12].The EC based its approval of Onbrez Breezhaler on data from over6,000 patients. This data included pivotal Phase III results showingOnbrez Breezhaler significantly improved lung function[1] andprovided clinically relevant improvement in symptoms ofbreathlessness compared to tiotropium[13]. Recent data presented atthe American College of Chest Physicians (ACCP) Chest Conferenceshowed once-daily Onbrez Breezhaler also achieved significantimprovements in lung function compared to twice-daily salmeterol,another current treatment option[3]. In addition, Onbrez Breezhalerprovided better health status* and improved breathlessness comparedwith salmeterol[3].Onbrez Breezhaler has shown good overall safety and tolerability,which is comparable to other current treatments[3,14,15]. The mostcommon adverse drug reactions were nasopharyngitis, cough, upperrespiratory tract infection, and headache[16]. These were in the vastmajority mild or moderate and became less frequent as treatment wascontinued[16].QAB149 was filed with the United States Food and Drug Administration(FDA) in late 2008. In October 2009, Novartis received a CompleteResponse letter from the US. The FDA requested additional informationon the dosing proposed, which Novartis is working to address.Improving the management of COPD is a priority focus for Novartis andOnbrez Breezhaler is the lead compound in an expected once-dailyportfolio for the treatment of this growing public health issue.Novartis has three additional investigational treatments in itslate-stage COPD portfolio, NVA237, QVA149 and QMF149. Novartis isalso exploring new pathways in the treatment of COPD as part of aninnovative, early-stage pipeline with disease modifying potential.About COPDCOPD is commonly caused by cigarette smoke and other harmful fumes,and is characterized by a persistent obstruction of airflow in thelungs, resulting in breathlessness[10]. COPD is currently projectedto become the third leading cause of death worldwide by 2020[9].Bronchodilators are a group of drugs that widen the airways in thelungs and are considered the cornerstone of COPD treatment, relievingsymptoms and preventing exacerbations. While incurable, COPD ismanageable, and improving airflow with the use of long-actingbronchodilators is central to symptomatic relief[17].*For this study, health status was assessed using St. George'sRespiratory Questionnaire, a standardized self-completedquestionnaire for measuring impaired health and perceived well-being.DisclaimerThe foregoing release contains forward-looking statements that can beidentified by terminology such as "projected," "will," "expected,""exploring," "potential," or similar expressions, or by express orimplied discussions regarding potential marketing, additionalmarketing approvals for Onbrez Breezhaler 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 Onbrez Breezhaler will beapproved in any additional markets, or that 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. Fogarty C, Hébert J, Iqbal A et al. Indacaterol once-daily provides effective 24-h bronchodilation in COPD patients: a 26-week evaluation vs placebo and tiotropium. Eur Respir J 2009;34 (Suppl. 53):P2025. 2. Dahl R, Kolman P, Jack D et al. Bronchodilator therapy with indacaterol once-daily in COPD: a 52-week comparison with formoterol. Eur Respir J 2009;34 (Suppl.53):E4350. 3. Kornmann O, Luthra A, Roger Owen R et al. Once-daily indacaterol provides superior bronchodilation, health status and clinical outcomes compares with salmeterol in patients with chronic obstructive pulmonary disease (COPD): A 26-week placebo-controlled study. Chest 2009;136:152S. 4. Balint B, Watz H, Amos C et al. Fast onset of bronchodilation with indacaterol in patients with COPD. Eur Respir J 2009;34 (Suppl.53):E4363. 5. Vogelmeier C, Ramos-Barbon D, Damon J et al. Once-daily indacaterol provides effective 24-hour bronchodilation in COPD: A double-blind comparison with tiotropium. Chest 2009;136:4S. 6. World Health Organization. Factsheet No 315 Chronic obstructive pulmonary disease (COPD). http://www.who.int/mediacentre/factsheets/fs315/en/index.html (accessed 27 November 2009). 7. Halbert RJ, Isonaka S, George D et al. Interpreting COPD Prevalence Estimates. What Is the True Burden of Disease? Chest 2003;123:1684-1692. 8. Lanzieri G. Population in Europe 2007: first results. Eurostat. Statistics in Focus 81/2008, Population and social conditions. 9. Murray CJ & Lopez AD. Alternative projections of mortality and disability by cause 1990-2020: Global Burden of Disease Study. Lancet 1997;349:1498-1504.10. NHBLI. What is COPD? http://www.nhlbi.nih.gov/health/dci/Diseases/Copd/Copd_WhatIs.html (accessed 27 November 2009).11. Data on file, Novartis Pharma AG: MattsonJack COPD Est. 2008 US + EU5; Global COPD Chart Pull & Attitudinal Study (Quant).12. World Health Organization 2007. Global surveillance, prevention and control of chronic respiratory diseases: a comprehensive approach. Bousquet J, Khaltaev N, editors.13. Mahler DA, Palange P, Iqbal A et al. Indacaterol once-daily improves dyspnoea in COPD patients: a 26-week placebo-controlled study with open-label tiotropium comparison. Eur Respir J 2009;34 (suppl.53):E4360.14. Worth H, Kleerup E, Iqbal A et al. Safety and tolerability of Indacaterol once-daily in COPD patients versus placebo and tiotropium: a 26-week study. Eur Respir J 2009;34 (Suppl.53):P2030.15. Chung KF, Kornmann O, Jack D et al. Safety and tolerability of indacaterol over 52 weeks of treatment in COPD. Eur Respir J 2009;34 (Suppl.53):E4359.16. Onbrez® Breezhaler® (Indacaterol) Summary of Product Characteristics. November 2009 (approved).17. Global Initiative for Chronic Obstructive Pulmonary Lung Disease. Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Lung Disease. Updated 2008. http://www.goldcopd.com/download.asp?intId=504 (accessed 10 November). # # #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 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/1358846/331011.pdf --- End of Message ---Novartis International AGPostfach Basel WKN: 904278; ISIN: CH0012005267; Index: SLCI, SMI, SPI, SLIFE;Listed: Main Market in SIX Swiss Exchange, ZLS in BX Berne eXchange;
Datum: 03.12.2009 - 07:15 Uhr
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