Novartis receives approval in the European Union for Exforge HCT®, a
new 3-in-1 treatment for high b
(Thomson Reuters ONE) - Corporate news announcement processed and transmitted by Hugin AS.The issuer is solely responsible for the content of this announcement. ------------------------------------------------------------------------------------ * Exforge HCT combines the efficacy of three widely prescribed blood pressure treatments, valsartan, amlodipine and hydrochlorothiazide, in a single pill * Up to 85% of patients may need multiple medications to help control their blood pressure[1],[2], underscoring the need for more effective combination treatments * Single-pill combinations reduce daily pill burden and simplify treatment schedules[3]Basel, October 23, 2009 - The European Commission has grantedNovartis marketing authorization for Exforge HCT®, a new 3-in-1treatment for people with high blood pressure.Exforge HCT combines in a once-daily single pill the efficacy ofthree widely prescribed blood pressure medications: the angiotensinreceptor blocker valsartan (Diovan®), the calcium channel blockeramlodipine, and the diuretic hydrochlorothiazide (HCT). All threehave been used extensively for many years in patients withhypertension."Novartis is committed to helping patients improve their treatmentcompliance. Simplified treatment regimens and reduced pill burdenshave been shown to help achieve this," said Joe Jimenez, CEO of theNovartis Pharmaceuticals Division. "We are pleased that with theapproval of Exforge HCT, a new 3-in-1 treatment for high bloodpressure is now available to patients in the EU. With Diovan as thefoundation of this new therapy, we are confident that it will becomean important new treatment option."In the EU, Exforge HCT is indicated for substitution therapy in adultpatients whose blood pressure is adequately controlled on thecombination of valsartan, amlodipine and HCT, taken either as threesingle-component formulations or as a dual-component and asingle-component formulation[4].High blood pressure, or hypertension, is one of the most importantbut treatable risk factors for cardiovascular disease - the numberone cause of death worldwide[5]. Nearly half of Europeans suffer fromhigh blood pressure[6] and up to 85% of these patients may needmultiple medications to help reach treatment goals[1],[2]. Theprimary patient-related factor for hypertension treatment failure isnon-compliance with the prescribed antihypertensive medication[7].Patients therefore may find treatment more convenient with one singlepill rather than multiple separate pills. One recent, large-scalestudy showed that approximately 75% of patients achieved their bloodpressure treatment goal after switching to a single-pill combinationtherapy[8]."It is not uncommon for patients with severe hypertension, or thoserequiring stricter blood pressure control, to need three or moremedications," said Professor Rainer Düsing, MD, of the Faculty ofMedicine, University of Bonn, Germany. "Now that this new single-pilltriple-combination option is available, appropriate patients may findit easier to comply with their prescribed treatment regimensinvolving a once-daily single pill versus multiple medications,especially if it has also been proven to be highly effective athelping patients reach their blood pressure goals."Exforge HCT was approved in the United States by the Food and DrugAdministration (FDA) in April 2009 for the second-line treatment ofhigh blood pressure[9]. It was approved in Switzerland in September2009 for the treatment of patients whose blood pressure is notadequately controlled by dual therapy[10].The EU approval was supported by the results of Study 230211, amultinational, randomized, double-blind, parallel-group, Phase IIIstudy designed to compare the efficacy and safety of triple therapy(valsartan, amlodipine and HCT) with the various dual combinations ofits components - valsartan/HCT, amlodipine/valsartan oramlodipine/HCT - in patients with moderate-to-severe hypertension.The trial was conducted in 15 countries, with 2,271 patientsrandomized to double-blind treatment.Study 2302 showed that triple therapy was more effective in reducingsystolic and diastolic blood pressure than dual combinations of itscomponents in patients with moderate-to-severe hypertension[11].Reductions in mean sitting systolic blood pressure of 40 to 50 mmHgwere achieved, with up to 58% more patients receiving triple therapyachieving overall blood pressure control versus dual therapy (i.e.blood pressure <140/90 mmHg). The maximum dose of triple therapy(valsartan/amlodipine/HCT 10/320/25 mg) demonstrated additionalreductions of 18-29% in systolic blood pressure and 19-32% indiastolic blood pressure when compared to all dual combinations ofits components at the same doses. Ambulatory blood pressuremonitoring showed that the blood pressure- lowering effect of tripletherapy was maintained throughout the 24-hour period[12]. Inaddition, the study showed that triple therapy was highly effectiveregardless of patients' age, gender, race, ethnicity or baselineblood pressure, and was generally well tolerated versus dualtherapy[11].The core of the Novartis portfolio is its cardiovascular andmetabolic medications for the treatment of high blood pressure anddiabetes. These include Diovan® (valsartan), the number one sellingblood pressure medication worldwide[13]; Exforge® (valsartan/amlodipine), a single pill combining two leading medicines for highblood pressure; Exforge HCT® (valsartan/amlodipine/HCT); and Rasilez®(aliskiren), the first and only approved direct renin inhibitor, andtwo single pill combinations of Rasilez, Rasilez HCT (aliskiren/HCT)and Valturna (aliskiren/valsartan). For the treatment of type 2diabetes, these include Galvus® (vildagliptin, a novel DPP-4inhibitor) and Eucreas® (vildagliptin and metformin).DisclaimerThe foregoing release contains forward-looking statements that can beidentified by terminology such as "may," "committed," "confident,""will," or similar expressions, or by express or implied discussionsregarding potential future revenues from Exforge HCT. You should notplace undue reliance on these statements. Such forward-lookingstatements reflect the current views of management regarding futureevents, and involve known and unknown risks, uncertainties and otherfactors that may cause actual results with Exforge HCT to bematerially different from any future results, performance orachievements expressed or implied by such statements. There can be noguarantee that Exforge HCT will achieve any particular levels ofrevenue in the future. In particular, management's expectationsregarding Exforge HCT 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; the company's ability to obtain or maintain patent orother proprietary intellectual property protection; competition ingeneral; government, industry and general public pricing pressures;the impact that the foregoing factors could have on the valuesattributed to the Novartis Group's assets and liabilities as recordedin the Group's consolidated balance sheet, and other risks andfactors referred to in Novartis AG's current Form 20-F on file withthe 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.] Dahlöf B, et al. Prevention of cardiovascular events with anantihypertensive regimen of amlodipine adding perindopril as requiredversus atenolol adding bendroflumethiazide as required, in theAnglo-Scandinavian Cardiac Outcomes Trial-Blood Pressure Lowering Arm(ASCOT-BPLA): a multicenter randomized controlled trial. Lancet2005;366:895-906.[2.] Pepine CJ, et al. A calcium antagonist vs. a non-calciumantagonist hypertension treatment strategy for patients with coronaryartery disease: the International Verapamil-Trandolapril Study(INVEST): a randomized controlled trial. JAMA 2003;290:2805-16.[3.] Mancia G, et al. 2007 Guidelines for the management of arterialhypertension: The Task Force for the Management of ArterialHypertension of the European Society of Hypertension (ESH) and of theEuropean Society of Cardiology (ESC). Eur Heart J 2007;28:1462-536.[4.] Exforge HCT® EU Summary of Product Characteristics. NovartisPharma AG.[5.] World Health Organization. Cardiovascular diseases factsheet.Available at:http://www.who.int/mediacentre/factsheets/fs317/en/index.html.[6.] Wolf-Maier K, et al. Hypertension prevalence and blood pressurelevels in 6 European countries, Canada, and the United States. JAMA2003;289:2363-9.[7.] Elliott WJ. What factors contribute to the inadequate control ofelevated blood pressure? J Clin Hypertens (Greenwich) 2008;10(1Suppl. 1):20-6.[8.] Jamerson K, et al. Benazepril plus amlodipine orhydrochlorothiazide for hypertension in high-risk patients. N Engl JMed 2008;359:2417-28.[9.] Exforge HCT® US Prescribing Information. April 2009. Availableat: http://www.pharma.us.novartis.com/product/pi/pdf/exforge_hct.pdf[10.] Exforge HCT® Swiss Prescribing Information. September 2009.[11.] Calhoun DA, et al. Triple antihypertensive therapy withamlodipine, valsartan, and hydrochlorothiazide. A randomized clinicaltrial. Hypertension 2009;54(1):32-9.[12.] Lacourciere Y, et al. Twenty-four hour ambulatory BP Control oftherapy with amlodipine/valsartan/HCTZ triple combination compared todual therapy in patients with moderate to severe hypertension.Presented at the 19th Scientific Meeting of the European Society ofHypertension, June 14, 2009; Abstract No: 1412. Updated informationpresented at meeting.[13.] IMS Midas Worldwide Sales Data. May 2009. # # #Novartis Media RelationsCentral media line : +41 61 324 2200Eric Althoff Katharine HarrisNovartis Global Media Relations Novartis Pharma Communications+41 61 324 7999 (direct) +41 (0) 61 324 07 99 (direct)+41 79 593 4202 (mobile) +41 (0) 79 515 2816 (mobile)eric.althoff(at)novartis.com katharine.harris(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/1349636/325328.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: 23.10.2009 - 07:15 Uhr
Sprache: Deutsch
News-ID 7308
Anzahl Zeichen: 0
contact information:
Town:
London
Kategorie:
Business News
Diese Pressemitteilung wurde bisher 687 mal aufgerufen.
Die Pressemitteilung mit dem Titel:
"Novartis receives approval in the European Union for Exforge HCT®, a
new 3-in-1 treatment for high b"
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).
