Three new Novartis medicines approved in Japan for patients with type 2 diabetes, high blood pressur
(Thomson Reuters ONE) - Novartis International AG / Three new Novartis medicines approved in Japan for patients with type 2 diabetes, high blood pressure and advanced kidney cancer processed and transmitted by Hugin AS. The issuer is solely responsible for the content of this announcement. * Equa®, Exforge® and Afinitor® provide new treatment options for unmet medical needs * Three major approvals for innovative medicines to treat serious and life-threatening diseases affecting millions of Japanese patients * Approvals follow six product launches in 2009, reinforcing the strong presence of Novartis in Japan, the company's second-largest pharmaceutical marketBasel, January 20, 2010 - Patients in Japan will benefit from the approval ofthree new Novartis medicines - Equa® (vildagliptin), marketed as Galvus® in theEuropean Union, for the treatment of type 2 diabetes, Exforge®(valsartan/amlodipine) for high blood pressure, and Afinitor® (everolimus) foradvanced kidney cancer. These approvals reinforce the strong commitment ofNovartis to helping patients in Japan, the company's second-largestpharmaceutical market."It is a significant achievement to secure the approval of three such importantnew medicines for the benefit of Japanese patients," said Joe Jimenez, CEO ofthe Novartis Pharmaceuticals Division. "These approvals, which follow sixlaunches last year, mean we continue to quickly introduce innovative medicinesto treat serious and life-threatening diseases affecting millions of Japanesepatients and their families."Equa has been approved in Japan for the treatment of type 2 diabetes, asmonotherapy or in combination with a sulfonylurea. As a DPP-4 inhibitor, Equaworks by targeting the dysfunction in the pancreatic islets that causes highblood sugar levels in people with type 2 diabetes.Equa has been approved for doses of 50 mg twice daily, or 50 mg once daily,depending on the needs of the individual patient[1]. Patients treated with Equa50 mg twice daily demonstrated an average reduction in HbA1c - a marker of bloodglucose level - of 1.2% compared to placebo[2], which would bring half of themwithin the maximum HbA1c value of 6.5% recommended by the Japan DiabetesSociety[2]. Equa was shown to be well-tolerated with a favorable profile interms of hypoglycemia and bodyweight[2].An estimated 7 million people in Japan have type 2 diabetes[3] and approximately70% of patients are still not meeting their HbA1c goals on their currentmedications[4]. When left untreated or inadequately controlled, type 2 diabetescan lead to heart and kidney disease, blindness, and vascular or neurologicproblems[5].Exforge has been approved in Japan as a single-pill combination of twotreatments for high blood pressure: Diovan® (valsartan), the number one sellinghypertension medication worldwide[6], and amlodipine, the world's mostprescribed calcium channel blocker[6]. Exforge has been shown to be effectiveacross all grades of high blood pressure[7], [8], with placebo-liketolerability[9]. As many as nine out of 10 Exforge patients reach their bloodpressure goal[10], with drops of up to 43 mmHg reported in patients withparticularly elevated blood pressure[8].High blood pressure affects an estimated 40 million people in Japan; nearly athird of the population[11]. With approximately 70% of patients not reachingtheir blood pressure treatment goal[12], there is a growing need for effectiveand convenient single-pill combination therapies. High blood pressure is one ofthe most important treatable risk factors for cardiovascular disease - thenumber one cause of death worldwide[13].Afinitor (everolimus) in tablet form has been approved in Japan for thetreatment of patients with non-resectable, metastatic renal cell carcinoma(advanced kidney cancer). Each year, more than 10,000 people in Japan arediagnosed with kidney cancer[14].A once-daily therapy, Afinitor provides continuous inhibition of the mTORprotein, a central regulator of tumor cell division and blood vessel growth incancer cells. Afinitor is the first mTOR inhibitor approved to treat advancedkidney cancer patients in Japan.Japan took part in the pivotal, international, Phase III trial for Afinitor onwhich the approval was based. The trial, RECORD-1 (REnal Cell cancer treatmentwith Oral RAD001 given Daily), included patients from 14 trial sites acrossJapan. RECORD-1 showed that Afinitor, when compared with placebo, more thandoubled the median time without tumor growth or death in patients with advancedkidney cancer whose disease progressed following earlier VEGF-targeted therapy(4.9 vs. 1.9 months, p<0.0001) [15]. Prior to Afinitor, no other therapy hadbeen studied in a Phase III trial in this patient population where there is animportant unmet medical need.This regulatory decision marks the third major approval for Afinitor in lessthan a year, following approvals in the European Union and UnitedStates[15],[16]. Afinitor is also being studied worldwide in multiple tumortypes, including in Japanese patients with pancreatic neuroendocrine tumors,gastric cancer, lymphoma and breast cancer.As an investigational compound, the safety and efficacy profile of everolimushas not yet been established in these cancer and tumor types. Because of theuncertainty of clinical trials, there is no guarantee that everolimus will everbecome commercially available for these cancer and tumor types anywhere in theworld. In Japan, everolimus is available in different dosage strengths under thetrade name Certican® for the prevention of organ rejection in heart transplantrecipients.Novartis Pharma K.K. is a Japanese affiliate of Novartis AG, Switzerland. Formore information on NPKK, please visithttp://www.novartis.co.jp/.DisclaimerThe foregoing release contains forward-looking statements that can be identifiedby terminology such as "commitment," "can," "will," or similar expressions, orby express or implied discussions regarding potential new indications orlabeling for Afinitor, potential future approvals of Novartis products in Japan,or regarding potential future revenues from the products referred to in thisrelease or from Novartis products sold in Japan. You should not place unduereliance on these statements. Such forward-looking statements reflect thecurrent views of management regarding future events, and involve known andunknown risks, uncertainties and other factors that may cause actual results tobe materially different from any future results, performance or achievementsexpressed or implied by such statements. There can be no guarantee that Afinitorwill be approved for any additional indications or labeling in any market. Norcan there be any guarantee that these products, or any other Novartis productssold in Japan, will achieve any particular levels of revenue in the future. Inparticular, management's expectations could be affected by, among other things,unexpected regulatory actions or delays or government regulation generally;unexpected clinical trial results, including unexpected new clinical data andunexpected additional analysis of existing clinical data; the company's abilityto obtain or maintain patent or other proprietary intellectual propertyprotection; competition in general; government, industry and general publicpricing pressures; the impact that the foregoing factors could have on thevalues attributed to the Novartis Group's assets and liabilities as recorded inthe Group's consolidated balance sheet, and other risks and factors referred toin Novartis AG's current Form 20-F on file with the US Securities and ExchangeCommission. Should one or more of these risks or uncertainties materialize, orshould underlying assumptions prove incorrect, actual results may varymaterially from those anticipated, believed, estimated or expected. Novartis isproviding the information in this press release as of this date and does notundertake any obligation to update any forward-looking statements contained inthis press release as a result of new information, future events or otherwise.About NovartisNovartis provides healthcare solutions that address the evolving needs ofpatients and societies. Focused solely on healthcare, Novartis offers adiversified portfolio to best meet these needs: innovative medicines,cost-saving generic pharmaceuticals, preventive vaccines, diagnostic tools andconsumer health products. Novartis is the only company with leading positions ineach of these areas. In 2008, the Group's continuing operations achieved netsales of USD 41.5 billion and net income of USD 8.2 billion. Approximately USD7.2 billion was invested in R&D activities throughout the Group. Headquarteredin Basel, Switzerland, Novartis Group companies employ approximately 99,000full-time-equivalent associates and operate in more than 140 countries aroundthe world. For more information, please visithttp://www.novartis.com.References[1] Equa package insert in Japan.[2]Kikuchi M, et al. Vildagliptin dose-dependently improves glycemic control inJapanese patients with type 2 diabetes mellitus. Diabetes Research and ClinicalPractice 83 (2009) 233-240. Published online 31 December 2008.Doi:10.1016/j.diabres.2008.10.006.[3] International Diabetes Federation. "Diabetes Atlas, fourth edition." 2009.Online version of the Diabetes Atlas is available at www.eatlas.idf.org
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Datum: 20.01.2010 - 01:15 Uhr
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