New Phase II data show ACZ885 gave better pain relief and flare
prevention for patients with chronic
(Thomson Reuters ONE) - Corporate news announcement processed and transmitted by Hugin AS.The issuer is solely responsible for the content of this announcement. ------------------------------------------------------------------------------------ * ACZ885 provided pain relief and reduced risk of flares by 94% versus an injectable corticosteroid in hard-to-treat patients unable to use common gout medicines[1] * Gout is one of the most painful forms of arthritis involving acute attacks of inflammation that can damage joints and bone[2],[3] * ACZ885 blocks action of inflammatory protein interleukin-1 beta which plays key role in causing painful gout flares[4],[5],[6]Basel, October 20, 2009 - New Phase II results show that the novelbiological therapy ACZ885 (canakinumab) is significantly moreeffective than an injectable corticosteroid at reducing pain andpreventing recurrent attacks or 'flares' in patients withhard-to-treat gout, one of the most painful forms of arthritis[1].The study met its primary endpoint by showing that during acute goutflares, ACZ885 reduced pain faster and more effectively than theinjectable corticosteroid triamcinolone acetonide[1], a potentsteroid with sustained effect used to treat severe inflammatoryconditions (p<0.05)[7].At the end of the eight-week study, the risk of flare recurrence was94% less for patients on ACZ885 than on the steroid (p=0.006)[1]. Theresults were presented today at the American College of Rheumatology(ACR) Annual Scientific Meeting in Philadelphia, USA."If not appropriately treated, gout can be a devastating condition.Current therapies can have limited efficacy and tolerability, and maybe unsuitable for some patients[8],[9]," said Professor Alexander So,MD, Department of Rheumatology at the University of Lausanne,Switzerland. "These results are important as they indicate thatcanakinumab may provide significant benefit in both the preventionand treatment of painful acute flares in these hard-to-treatpatients."ACZ885 is a fully human monoclonal antibody which blocks the actionof the inflammatory protein interleukin-1 beta (IL-1 beta). It hasalready been approved under the brand name Ilaris® in a number ofcountries for treating cryopyrin-associated periodic syndrome (CAPS),a rare life-long auto-inflammatory disease with debilitating symptomsand few treatment options.Studies with ACZ885 are ongoing in other diseases in which IL-1 betaplays an important role, such as chronic obstructive pulmonarydisease (COPD), type 2 diabetes and systemic juvenile idiopathicarthritis (SJIA). Not all potential patients with these diseaseswould be eligible for treatment with ACZ885, if approved.Gout, also known as gouty arthritis, affects more than 1% of adultsin Western countries[10],[11]. It is more common in older people,with around 10% of men and 6% of women over 70 years old sufferingfrom the disease[6],[12],[13]. Approximately one in 10 patients havepoorly controlled gout resulting in more frequent flares[14]. Theyare regarded as being 'hard-to-treat' as they are often intolerant orunresponsive to standard medications such as colchicine ornon-steroidal anti-inflammatory drugs (NSAIDs)[15]. Corticosteroidshave traditionally been given to these patients as a last resort totreat acute pain, but they may have significant side effects[7],[16].Gout is caused by the accumulation of uric acid crystals leading tosevere inflammation in the joints and surrounding tissue[2],[3].Recent advances in the understanding of the disease have shown thaturic acid crystals activate production of IL-1 beta, which isresponsible for the inflammatory symptoms experienced by goutpatients[6]. ACZ885 provides a potent and selective blockade of IL-1beta for a sustained period, neutralizing it and reducinginflammation[4],[17],[18]."The devastating impact of chronic gout is often underestimated byboth healthcare professionals and the general public, and there is areal unmet need among patients," said Trevor Mundel, MD, Head ofGlobal Development at Novartis Pharma AG. "The latest data areencouraging for patients with hard-to-treat gout in whom the diseaseis not effectively managed, resulting in chronic pain. These findingsalso reinforce the potential of ACZ885 in a number of inflammatorydiseases where IL-1 beta plays a key role."The results presented at ACR were from a randomized, single-blind,double-dummy Phase II study involving 200 patients aged 18-80 yearsold with chronic gout, designed to assess the efficacy and optimumdose of ACZ885 in patients for whom current treatments (colchicineand/or NSAIDs) are ineffective or contraindicated[1].The study showed that patients given ACZ885 150 mg experienced fasterand more effective pain relief than those given the corticosteroidtriamcinolone acetonide from 24 hours up to seven days[1]. ACZ885 wasgiven by subcutaneous injection, i.e. under the skin, whereas thesteroid was given by intramuscular injection, i.e. into the muscle.No pattern of adverse events was seen in any of the treatment groupsand the incidence of adverse events was similar for bothmedicines[1]. Serious adverse events occurred in two patientsreceiving ACZ885 and one receiving triamcinolone acetonide.Investigators reported that these events were not related to thestudy drug[1]. There were no discontinuations due to adverseevents[1].Ilaris has been launched in the US and Switzerland, and received apositive opinion recommending approval in the EU in July 2009 totreat adults and children over four years old with CAPS. In the US,Ilaris is approved to treat adults and children four years of age andolder with CAPS, including Familial Cold Autoinflammatory Syndrome(FCAS) and Muckle-Wells Syndrome (MWS). Reviews are ongoing in othercountries including priority review in Australia, Brazil and Canada.Ilaris has been designated as an orphan drug for treating SJIA in theUS, EU and Switzerland, and has fast-track status for SJIA in the US.DisclaimerThe foregoing release contains forward-looking statements that can beidentified by terminology such as "can", "may," "potential,""priority review," "fast-track status," or similar expressions, or byexpress or implied discussions regarding potential additionalindications for Ilaris, or regarding potential future revenues fromIlaris. You should not place undue reliance on these statements. Suchforward-looking statements reflect the current views of the Companyregarding future events, and involve known and unknown risks,uncertainties and other factors that may cause actual results withIlaris to be materially different from any future results,performance or achievements expressed or implied by such statements.There can be no guarantee that Ilaris will be approved for anyadditional indication. Nor can there be any guarantee that Ilariswill achieve any levels of revenue in the future. In particular,management's expectations regarding Ilaris could be affected by,among other things, unexpected clinical trial results, includingunexpected new clinical data and unexpected additional analysis ofexisting clinical data; unexpected regulatory actions or delays orgovernment regulation generally; the company's ability to obtain ormaintain patent or other proprietary intellectual propertyprotection; competition in general; government, industry and generalpublic pricing pressures; the impact that the foregoing factors couldhave on the values attributed to the Group's assets and liabilitiesas recorded in the Group's consolidated balance sheet, and otherrisks and factors referred to in Novartis AG's current Form 20-F onfile with the US Securities and Exchange Commission. Should one ormore of these risks or uncertainties materialize, or shouldunderlying assumptions prove incorrect, actual results may varymaterially from those anticipated, believed, estimated or expected.Novartis is providing the information in this press release as ofthis date and does not undertake any obligation to update anyforward-looking statements contained in this press release as aresult 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 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 approximately99,000 full-time-equivalent associates and operate in more than 140countries around the world. For more information, please visithttp://www.novartis.com.References[1.]So A, De Meulemeester M, Shamim T et al. Canakinumab (ACZ885) vs.triamcinolone acetonide for treatment of acute flares and preventionof recurrent flares in gouty arthritis patients refractory to orcontraindicated to NSAIDs and/or colchicine. Abstract presented atthe American College of Rheumatology Annual Meeting, Philadelphia,United States of America (US), October 17-21, 2009.[2.] Martinon F, Glimcher LH. Gout: new insights into an old disease.J Clin Invest, 2006;116: 2073-5.[3.] Choi HK, Curhan G. Gout: epidemiology and lifestyle choices.Curr Opin Rheumatol, 2005; 17: 341-5.[4.] Alten R, Gram H, Joosten LA, et al. The humananti-interleukin-1ÿ (IL-1ÿ) monoclonal antibody ACZ885 is effectivein joint inflammation models in mice and in a proof of concept studyin rheumatoid arthritis patients. Arthritis Res Ther, 2008; 10: R67.[5.] Carneiro LA, Magalhaes JG, Tattoli I et al. Nod-like proteins ininflammation and disease. J Pathol, 2008 Jan; 214(2): 136-48.[6.] So A. Developments in the scientific and clinical understandingof gout. Arthritis Res Ther, 2008; 10: 221-226.[7.] KENALOG-10. Triamcinolone acetonide injection, suspension. USFDA label. Available at:http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=6526 Accessed:13 October 2009.[8.] Harrold LR, Andrade SE, Briesacher BA et al. Adherence withurate-lowering therapies for the treatment of gout. Arthritis ResTher, 2009; 11: R46.[9.] Ganson NJ, Kelly SJ, Scarlett E et al. Control of hyperuricemiain subjects with refractory gout, and induction of antibody againstpoly(ethylene glycol) (PEG), in a phase I trial of subcutaneousPEGylated urate oxidase. Arthritis Res Ther, 2006; 8: R12.[10.] Terkeltaub RA. Learning how and when to employ uricase asbridge therapy in refractory gout. J Rheumatol, 2007; 34: 1955-8.[11.] Bieber JD, Terkeltaub RA. Gout: on the brink of noveltherapeutic options for an ancient disease. Arthritis and Rheumatism,2004; 50: 2400-2414.[12.] Kramer HM, Curhan G. The association between gout andnephrolithiasis: The National Health and Nutrition Examination SurveyIII, 1988-1994. Am J Kidney Dis, 2002; 40: 37-42.[13.] Mikuls TR, Farrar JT, Bilker WB et al. Gout epidemiology:results from the UK General Practice Research Database, 1990-1999.Ann Rheum Dis, 2005; 64; 267-272.[14.] Halpern R, Fuldeore MJ, Mody RR et al. The Effect of SerumUrate on Gout Flares and Their Associated Costs. An AdministrativeClaims Analysis. J Clin Rheumatol, 2009; 15(1): 3-7.[15.] Strand V et al. Oral presentation at the European LeagueAgainst Rheumatism (EULAR) 2009 (Abstract 291).[16.] Pascual E, Sivera F. Therapeutic advances in gout. Curr OpinRheumatol, 2007; 19: 122-7.[17.] National Horizon Scanning Centre. Canakinumab for cryopyrinassociated periodic syndrome. November 2008. Available at:http://www.pcpoh.bham.ac.uk/publichealth/horizon/outputs/documents/2008/sept-dec/Canakinumab.pdf Accessed: 02 October 2009.[18.] Lachmann HJ, Lowe P, Felix SD et al. In vivo regulation ofinterleukin 1 in patients with cryopyrin-associated periodicsyndromes. J. Exp. Med, 2009. Published online April 13 2009.Available at: www.jem.org/cgi/doi/10.1084/jem.20082481. Accessed: 02October 2009. # # #Novartis Media RelationsEric Althoff Irina FerlugaNovartis Global Media Relations Novartis Pharma Communications+41 61 324 7999 (direct) +41 61 324 2422 (direct)+41 79 593 4202 (mobile) +41 79 824 1121 (mobile)eric.althoff(at)novartis.com irina.ferluga(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/1348439/324523.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: 20.10.2009 - 07:15 Uhr
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