Japanese Ministry of Health approves Rasilez®, a first-in-class
direct renin inhibitor (DRI), for th
Japanese Ministry of Health approves Rasilez®, a first-in-class direct renin inhibitor (DRI), for the treatment of high blood pressure
(Thomson Reuters ONE) - Corporate news announcement processed and transmitted by Hugin AS.The issuer is solely responsible for the content of this announcement. ------------------------------------------------------------------------------------ * Rasilez provides significant blood pressure reductions that last for 24 hours [1],[2], when taken alone or in combination with other antihypertensives[3-6] * An estimated 40 million people in Japan, nearly a third of the population, have high blood pressure[7], 70% of whom are not achieving treatment goals[8] * Rasilez's potential long-term benefits are being further investigated as part of ASPIRE HIGHER - the largest ongoing cardio-renal outcomes programBasel, July 8, 2009 - Rasilez® (aliskiren), the first new type ofhigh blood pressure medicine in more than a decade, has been approvedfor use in Japan. Rasilez directly inhibits renin[9], an enzyme thattriggers a process leading to high blood pressure and organ damage.The Ministry of Health, Labour and Welfare (MHLW) in Japan approvedRasilez for the treatment of high blood pressure alone or incombination with other high blood pressure medicines.High blood pressure is the leading risk factor for cardiovasculardisease, the number one cause of death worldwide[10]. In Japan anestimated 40 million people, nearly a third of the population, areaffected by high blood pressure[7] with the majority of patients notreaching their blood pressure treatment goal[8]."In Japan, nearly 70% of patients are not reaching their bloodpressure goal, demonstrating a strong need for therapies with a newmechanism of action," said Professor Toshiro Fujita, Chief of theDepartment of Nephrology and Endocrinology, University of Tokyo. "Itis expected that Rasilez's unique mechanism of action will providesignificant blood pressure reductions that last for 24 hours."It is estimated that nearly one billion people globally have highblood pressure[11] and many of these remain either untreated ortreated but not reaching their target[11]. Patients are therefore atrisk of complications including heart attack, stroke, kidney failure,blindness and death, creating an unmet need for new high bloodpressure therapies[11].Rasilez, known as Tekturna® in the US[*], works by directlyinhibiting renin to reduce the effects caused by an over-active reninsystem[9]. By inhibiting renin at the point of activation, Rasilezprovides significant blood pressure reductions alone or incombination with other antihypertensives[3-6].The potential long-term benefits of Rasilez are currently beinginvestigated further in the landmark ASPIRE HIGHER program, thelargest ongoing cardio-renal outcomes program worldwide, involvingmore than 35,000 patients in 14 trials."We are very excited about the approval in Japan, which providesJapanese patients access to this innovative high blood pressuretreatment that directly targets renin," said Trevor Mundel, MD,Global Head of Development at Novartis Pharma AG. "Novartis iscommitted to supporting the research and development of effective andinnovative treatments for patients suffering high blood pressure."Rasilez is approved in over 70 countries. Tekturna was approved inthe US in March 2007 and in the European Union in August 2007 underthe trade name Rasilez. Tekturna HCT, the first single-pillcombination involving Tekturna, was approved in the US in January2008. The single-pill combination Rasilez HCT was approved by theEuropean Commission in January 2009.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 world's most-prescribedangiotensin receptor blocker, the first and only approved directrenin inhibitor, a single pill combining two leading high bloodpressure medicines, and a DPP-4 inhibitor.DisclaimerThe foregoing release contains forward-looking statements that can beidentified by terminology such as "estimated," "potential,""expected," "will," "committed," or similar expressions, or byexpress or implied discussions regarding potential new indications orlabeling for Rasilez/Tekturna or regarding potential future revenuesfrom Rasilez/Tekturna. You should not place undue reliance on thesestatements. Such forward-looking statements reflect the currentviews of management regarding future events, and involve known andunknown risks, uncertainties and other factors that may cause actualresults with Rasilez/Tekturna to be materially different from anyfuture results, performance or achievements expressed or implied bysuch statements. There can be no guarantee that Rasilez/Tekturna willbe approved for any additional indications or labeling in any market.Nor can there be any guarantee that Rasilez/Tekturna will achieve anyparticular levels of revenue in the future. In particular,management's expectations regarding Rasilez/Tekturna could beaffected by, among other things, unexpected clinical trial results,including unexpected new clinical data and unexpected additionalanalysis of existing clinical data; unexpected regulatory actions ordelays or government regulation generally; competition in general;government, industry and general public pricing pressures; thecompany's ability to obtain or maintain patent or other proprietaryintellectual property protection; the impact that the foregoingfactors could have on the values attributed to the Novartis Group'sassets and liabilities as recorded in the Group's consolidatedbalance sheet, and other risks and factors referred to in NovartisAG's current Form 20-F on file with the US Securities and ExchangeCommission. Should one or more of these risks or uncertaintiesmaterialize, or should underlying assumptions prove incorrect, actualresults may vary materially from those anticipated, believed,estimated or expected. Novartis is providing the information in thispress release as of this date and does not undertake any obligationto update any forward-looking statements contained in this pressrelease as a result of new information, future events or otherwise.About NovartisNovartis AG 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 these areas. In 2008, theGroup's continuing operations achieved net sales of USD 41.5 billionand net income of USD 8.2 billion. Approximately USD 7.2 billion wasinvested in R&D activities throughout the Group. Headquartered inBasel, Switzerland, Novartis Group companies employ approximately98,000 full-time-equivalent associates and operate in more than 140countries around the world. For more information, please visithttp://www.novartis.com.[*] Rasilez® is the trade name for aliskiren throughout the world,except in the US where it is known as Tekturna®.References[1] Oh BH, et al. Aliskiren, an Oral Renin Inhibitor, ProvidesDose-Dependent Efficacy and Sustained 24-hour Blood Pressure Controlin Patients with Hypertension. J Am Coll Cardiol 2007; 49:1157-63.[2] Palatini P, et al. Blood Pressure Reduction Following A SimulatedMissed Dose Of Aliskiren, Irbesartan, or Ramipril: A ComparativeAmbulatory Blood Pressure Monitoring Study. Presentation at AmericanSociety of Hypertension 2008.[3] Uresin Y, et al. Aliskiren Monotherapy Lowers Blood Pressure MoreEffectively than Ramipril Monotherapy in Patients with Diabetes andGrade 2 Hypertension: Subgroup Analysis of an 8-week, Double-BlindTrial. J Hypertens 2008: 26 (Suppl 1): S479 PS33/THU/62.[4] Oparil S, Yarows SA, Patel S, Fang H, Zhang J, Satlin A. Efficacyand Safety of Combined use of Aliskiren and Valsartan in Patientswith Hypertension: A Randomised, Double-Blind Trial. Lancet 2007;370:221-29.[5] Drummond W, et al. Antihypertensive Efficacy of the Oral DirectRenin Inhibitor Aliskiren as Add-on Therapy in Patients notResponding to Amlodipine Monotherapy. J Clin Hypertens 2007;9:742-50.[6] Gradman A, et al. Aliskiren in Combination withHydrochlorothiazide is Effective and well Tolerated during Long-TermTreatment of Hypertension. Presentation at the American Society ofHypertension 2007.[7] National Health and Nutrition Survey Report Japan, 2006.[8] Fujita T et al. Current situation and issue on medication forhypertension and hyperlipidemia: Progress Medicine 26:2297-2306,2006.[9] Tekturna® (aliskiren) Prescribing Information. Available at:www.tekturna.com.[10] World Health Organization. Cardiovascular disease factsheet.Available at:http://www.who.int/mediacentre/factsheets/fs317/en/index.html. Lastaccessed April 2009.[11] Chobanian AV et al. Seventh Report of the Joint NationalCommittee on prevention, detection, evaluation, and treatment of highblood pressure. Hypertension 2003;42:1206-51. # # #Novartis Media RelationsCentral media line : +41 61 324 2200Eric Althoff Yanyan ChangNovartis Global Media Relations Novartis Division 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 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/1327640/312828.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;
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