Novartis receives FDA approval for Valturna®, a single-pill
combination of valsartan and aliskiren,
(Thomson Reuters ONE) - Corporate news announcement processed and transmitted by Hugin AS.The issuer is solely responsible for the content of this announcement. ------------------------------------------------------------------------------------ * Valturna combines in a single pill valsartan, an angiotensin receptor blocker, with aliskiren, the only approved direct renin inhibitor * Valturna is the first therapy to target two points within the renin angiotensin aldosterone system (RAAS), which plays a key role in regulating blood pressure * Valturna offers significantly greater blood pressure reduction than either valsartan or aliskiren alone[1]Basel, September 17, 2009 - The US Food and Drug Administration (FDA)has approved Valturna® (aliskiren and valsartan) tablets, the firstand only medicine to target two key points within the renin system,also known as the renin angiotensin aldosterone system (RAAS), animportant regulator of blood pressure[2]. This is the first approvalfor Valturna, which is indicated for the treatment of high bloodpressure in patients not adequately controlled on aliskiren orangiotensin receptor blocker (ARB) monotherapy and as initial therapyin patients likely to need multiple drugs to achieve their bloodpressure goals[1]."This unique combination brings together the powerful blood pressurelowering effects of valsartan and aliskiren," said Joe Jimenez, CEOof the Novartis Pharmaceuticals Division. "It offers an importantadditional treatment option for physicians and hypertension patients,many of whom are not at their blood pressure goal. Valturna buildsupon our strong cardiovascular franchise and is consistent with ourlong-term commitment to developing effective and innovativetherapies. It further strengthens our growing portfolio ofsingle-pill combinations to treat high blood pressure."Valturna combines in a single pill valsartan, the active ingredientin Diovan®, the number one selling blood pressure medicationworldwide[3], and aliskiren, the active ingredient in Tekturna®, theonly approved direct renin inhibitor (DRI). Valturna offerssignificantly greater blood pressure reduction than either valsartanor aliskiren alone[1]."When it comes to diagnosing and treating high blood pressure, thereis a real need for innovative therapies that help patients get to ahealthier blood pressure range," said John Flack, M.D., Valturnainvestigator, and Chairman of the Department of Internal Medicine,Wayne State University, Detroit. "Now for the first time, we have atreatment option in one pill that targets two key points of the RAAS,which may be overactive in many hypertensive patients."This approval was primarily based on a pivotal eight-week randomized,double-blind, placebo-controlled clinical trial in approximately1,800 patients, which studied aliskiren 150 mg and 300 mg andvalsartan 160 mg and 320 mg alone and in combination. The initialdoses of aliskiren and valsartan were 150 mg and 160 mg,respectively, and were increased at four weeks to 300 mg and 320 mg,respectively. Blood pressure reductions with the aliskiren/valsartancombination were significantly greater than with the monotherapies orplacebo at the 8-week primary endpoint. Mean systolic and diastolicblood pressure reductions from baseline were 17.2/12.2 mmHg foraliskiren 300 mg/valsartan 320 mg, compared with 12.8/9.7 mmHg forvalsartan 320 mg, 13.0/9.0 mmHg for aliskiren 300 mg, and 4.6/4.1mmHg for placebo (p<0.05 for aliskiren/valsartan vs monotherapies orplacebo).The single-pill combination Valturna targets the RAAS in two ways.Valsartan blocks, at the receptor level, the action of angiotensinII, a component of the RAAS that causes blood vessels to tighten andnarrow. Aliskiren directly inhibits renin, an enzyme produced by thekidneys that starts a process that leads to formation of angiotensinII. An overactive RAAS may contribute to high blood pressure. Bytargeting two key points within the RAAS, Valturna helps bloodvessels relax and widen so blood pressure is lowered.Research suggests that up to 85% of patients with high blood pressuremay need multiple medications to help control their bloodpressure[4],[5] underscoring the need for effective combinationtreatments.High blood pressure affects over one billion individualsglobally[6],[7] and is a major risk factor for cardiovasculardisease, the number one leading cause of death worldwide[8]. If leftuntreated, patients with high blood pressure are at risk ofcardiovascular events such as stroke, heart attack and heart failure,and of organ damage including kidney failure and vision problems[6].Up to 65% of patients with high blood pressure do not have thecondition under control[9].About DiovanThe number one selling blood pressure medication worldwide[3] and oneof the fastest-growing high blood pressure drugs on the market today,Diovan is available as a powerful first-line treatment for high bloodpressure in more than 90 countries and in more than 65 countries forthe treatment of heart failure in patients who also take usualtherapy including diuretics, digitalis and either beta blockers orACE inhibitors, but not both. In the US and Switzerland, among othercountries, Diovan is indicated for the treatment of heart failure inpatients who cannot tolerate ACE inhibitors. Diovan is also indicatedin more than 50 countries to treat patients who have survived a heartattack.About TekturnaTekturna, a direct renin-inhibitor, is the only drug that works bydirectly targeting renin to decrease the activity of the RAAS[10].Renin is an enzyme produced by the kidneys that starts a process thatnarrows blood vessels and, when inappropriately activated, may leadto high blood pressure. Tekturna reduces plasma renin activity andhelps blood vessels relax and widen so blood pressure is lowered.The heart and kidney protection potential of Rasilez/Tekturna, inaddition to its blood pressure lowering ability, is currently beinginvestigated further in the landmark ASPIRE HIGHER program, thelargest ongoing cardio-renal outcomes program worldwide involvingmore than 35,000 patients in 14 trials.Rasilez/Tekturna is approved in over 70 countries. Tekturna wasapproved in the US in March 2007 and in the European Union in August2007 under the trade name Rasilez. In July 2009, Rasilez alsoreceived approval in Japan. Tekturna HCT, the first single-pillcombination involving Tekturna, was approved in the US in January2008 for second-line treatment of high blood pressure, and morerecently for first-line use. The single-pill combination Rasilez HCTwas approved in the European Union in January 2009. Other single-pillcombinations with Rasilez are currently in development including asingle pill combination with amlodipine.Novartis is focused on improving the lives of the hundreds ofthousands of people with cardiovascular and metabolic diseases. As aglobal leader in cardiovascular and metabolic health for nearly 50years, Novartis provides innovative therapies and support programs totreat high blood pressure and diabetes - both major public healthissues. The portfolio includes the number one selling blood pressuremedication worldwide, the first and only approved direct renininhibitor, a single pill combining two leading high blood pressuremedicines, and a DPP-4 inhibitor.Valturna is available in two strengths as tablets containingaliskiren and valsartan: 150 mg/160 mg and 300 mg/320 mg.DisclaimerThe foregoing release contains forward-looking statements that can beidentified by terminology such as "commitment," "may," "risk,""potential," or similar expressions, or by express or implieddiscussions regarding potential additional marketing approvals forValturna, potential new indications or labeling for Tekturna, orregarding potential future revenues from Valturna, Tekturna orDiovan. 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 resultsto be materially different from any future results, performance orachievements expressed or implied by such statements. There can be noguarantee that Valturna will be approved for sale in any additionalmarkets. Nor can there be any guarantee that Tekturna will beapproved for any additional indications or labeling in any market.Neither can there be any guarantee that Valturna, Tekturna or Diovanwill achieve any particular levels of revenue in the future. Inparticular, management's expectations regarding these products couldbe affected 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.] Valturna [prescribing information]. East Hanover, NJ: NovartisPharmaceuticals Corporation; 2009.[2.] CVF-300094/"RAAS"ing Your IQ. Novartis PharmaceuticalsCorporation. July 2009.[3.] IMS Midas Sales Worldwide. May 2009.[4.] Pepine CJ, Handberg EM, Cooper-DeHoff RM, et al, for the INVESTInvestigators. A calcium antagonist vs. a non- calcium antagonisthypertension treatment strategy for patients with coronary arterydisease. The International Verapamil-Trandolapril Study (INVEST): arandomized controlled trial. JAMA 2003; 290:2805-2816.[5.] Dahlöf B et al. Cardiovascular morbidity and mortality in theLosartan Intervention For Endpoint reduction in hypertension study(LIFE): a randomised trial against atenolol. Lancet 2002; 359:995-998.[6.] Chobanian AV, Bakris GL, Black HR, et al. and the National HighBlood Pressure Education Program Coordinating Committee. The seventhreport of the Joint National Committee on prevention, detection,evaluation, and treatment of high blood pressure. NIH Publication No.04-5230. August 2004.[7.] Kearney P, et al. Global Burden of Hypertension: Analysis ofWorldwide Data. Lancet 2005;365:217-23.[8.] World Health Organization. Cardiovascular disease factsheet.Available at:http://www.who.int/mediacentre/factsheets/fs317/en/index.html. Lastaccessed September 2009.[9.] Rosamond W et al. Heart disease and stroke statistics 2008update: a report from the American Heart Association StatisticsCommittee and Stroke Statistics Subcommittee. Circulation2008;117:e25-e146.[10.] Tekturna® (aliskiren) Prescribing Information. Available at:www.tekturna.com. # # #Novartis Media RelationsCentral media line : +41 61 324 2200Eric Althoff Yanyan ChangNovartis Global Media Relations Novartis Pharma Communications+41 61 324 7999 (direct) +41 61 324 2339 (direct)+41 79 593 4202 (mobile) +41 79 292 0959 (mobile)eric.althoff(at)novartis.com yanyan.chang(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 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/1342100/321142.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: 17.09.2009 - 22:00 Uhr
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