Novartis receives Complete Response letter from FDA for QAB149, an
investigational bronchodilator fo
(Thomson Reuters ONE) - Corporate news announcement processed and transmitted by Hugin AS.The issuer is solely responsible for the content of this announcement. ------------------------------------------------------------------------------------ * US Food and Drug Administration (FDA) has requested additional information on dosing proposed for QAB149 * Novartis will continue to work with the FDA to gain US approval for QAB149Basel, October 19, 2009 - Novartis has received a Complete Responseletter from the US Food and Drug Administration (FDA) as part of theUS regulatory review for QAB149 (indacaterol), an investigationalonce-daily bronchodilator for the treatment of adult patients withchronic obstructive pulmonary disease (COPD).The FDA has requested additional information on the dosing proposedfor QAB149. Novartis will work with the FDA to review alreadysubmitted data for QAB149 as well as recently available data todetermine what, if any, further clinical trials would be required."We will continue to work closely with the FDA to gain US regulatoryapproval for QAB149, which we believe could offer an important newtreatment option for patients with COPD," said Trevor Mundel, MD,Global Head of Development at Novartis Pharma AG. "Our confidence inthe benefit/risk profile of QAB149 is based on results of Phase IIItrials which showed QAB149 significantly improved lung function[1] inpatients with this severe disease and provided clinically relevantimprovement in symptoms such as breathlessness[2] compared to otherbronchodilators."QAB149 was submitted for US regulatory approval in December 2008 as anew once-daily bronchodilator for maintenance treatment of airflowobstruction in patients with COPD. The original submission was basedon a Phase III clinical trial program with three pivotal studies andenrolled 4,400 patients with moderate-to-severe COPD.In Europe, the Committee for Medicinal Products for Human Use (CHMP)issued a positive opinion in September 2009 supporting regulatoryapproval of QAB149 as a once-daily therapy with two doses (150micrograms and 300 micrograms). The European Commission generallyfollows the recommendations of the CHMP, which is the scientificcommittee of the European Medicines Agency.DisclaimerThe foregoing release contains forward-looking statements that can beidentified by terminology such as "will," "would," "believe,""could," "confidence," "generally follows the recommendations of," orsimilar expressions, or by express or implied discussions regardingpotential marketing approvals for QAB149 (indacaterol) or regardingpotential future revenues from such products. You should not placeundue reliance on these statements. Such forward-looking statementsreflect the current views of management regarding future events, andinvolve known and unknown risks, uncertainties and other factors thatmay cause actual results to be materially different from any futureresults, performance or achievements expressed or implied by suchstatements. There can be no guarantee that QAB149 will be approvedfor sale in any market. Nor can there be any guarantee that QAB149will achieve any particular levels of revenue in the future. Inparticular, management's expectations regarding QAB149 could beaffected by, among other things, unexpected regulatory actions ordelays or government regulation generally; unexpected clinical trialresults, including unexpected new clinical data and unexpectedadditional analysis of existing clinical data; competition ingeneral; government, industry and general public pricing pressures;the company's ability to obtain or maintain patent or otherproprietary intellectual property protection; the impact that theforegoing factors could have on the values attributed to the NovartisGroup'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. QAB149 once-daily provideseffective 24-h bronchodilation in COPD patients: a 26-week evaluationvs placebo and tiotropium. Poster presented at the EuropeanRespiratory Society (ERS) 2009 Annual Congress in Vienna, Austria,12-16 September 2009.[2] 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. Poster presented at the EuropeanRespiratory Society (ERS) 2009 Annual Congress in Vienna, Austria,12-16 September 2009. # # #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 Bringer +41 61 324 Richard Jarvis +1 212 830 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/1348153/324360.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: 19.10.2009 - 07:15 Uhr
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