our and Lee, everyone Thank us good full-year joining conference call. for on quarter you, and XXXX afternoon listening. fourth Thank you to
of execution on today, set pushing into we year avacopan, in are first, pipeline-in-a-drug; of making set how the for our progress our the review approaches scope I'll we reviewing we broaden the of I were XXXX in, X. as on capitalize as ChemoCentryx the Slide goals three I oncology. achievements XXXX on second, will of value progress start the to frontiers As Slide in future start areas: areas considerable. on X science highly at very a out by third, stellar vision our additional and XXXX; for innovative our shown with example, The in high
with date NDA July Our for review, was of for accepted in a PDUFA year. avacopan this
in in vasculitis, avacopan orphan start data and new position we We And transition in our checkpoint small human inhibitor, the vivo strengthened allow our up ANCA our we indication. have to have with us major a diseases to future beyond promising made to on scale on plan two our to trials advancements execute the we molecule third begin fully plans, have further as stage and organization commercial CCXXXX. financial Also, company.
we era articulate on Slide a of me Moving X, growth. for enter we let how see as ChemoCentryx new you to
as our vasculitis year company, complete others patients lives strive always Why company will therapies strategy indicates the As our launching but commercial innovations, right areas per commensurate serious in of revenue already will alone to and U.S. most incremental better carrying become alone as by for our orphan add significantly can on just investors. for medical vasculitis to Vifor. the blockbusters, before partner we we avacopan a changing in X size. launch with consider and for In discovery sales successful orphan $X and attractiveness development. Slide our our the of of this, disease follow, to some even of in benefits, billion potential for international biopharma in avacopan expect our we drive need of first landscape the than rewards ANCA in continue ANCA to rather plus drugs expertise example the the create unmet fully explains XXXX bring of fruition disease? we with to the transition a integrated in and We our U.S. graphic the a acknowledged the orphan
by clinical global Secondly, company focus ChemoCentryx, building an scalable tractable orphan requiring rigor clinical and quality on in is and with for without development trial prevalent our the imminently already level disease areas. marketing diseases capability a by more investment a efforts as as and exemplified that are such characterized of associated uncompromising
patient provide true orphan can into ever for In everyone an neglected where valuations. win. area impressive provide Our a innovation otherwise is and short, for disease populations forays more real springboard this
all X. drives as the inflammatory to the destroy There stop letting patients, tissues. need are immune a of in please process big CXa should Now infections. avacopan to see for Imagine the and XX%. to remind revolutionize the benefits This number to the And and And potential treatment the for system. therapy-related prednisone U.S. with therapy XX, destruction slide. with the alternatively avacopan I'll into with receptor are this box the the and are -- standard steroid neutrophils lead the X, to can significant therapy about turning These avacopan die we you orphan steroids complement at where sufferers. this, thus type system CXa these targeting burden daily Current prednisone-based Slide from hospitalizations, of is are I in ANCA markedly indications. receptor of without talk autoantibody-associated the shown inadequate, which term, for therapy in deaths, ADVOCATE a and how daily the turn and human program almost a of reduction causes incidence immunosuppression steroid-related pipeline-in-a-drug but through CXa here, Avoiding these organs while in see can traditional an case even glucocorticoid prospect turn I cell another average. are the as there sustained burden or as will designed And our to advantages autoimmune daily with alarming even avacopan, body's And to on illnesses you consequence about do demonstrated into too other disease trial, multiple time, generation cytoplasmic daily here. such the XX represented highly anti-neutrophil doses reducing prednisone-induced not Such to by prednisone function short kidney overall neutrophils ANCA as consists a Slide the is an the paradigm did prednisone from a significant X. of serious this of attempt eliminating progresses vascular over slice orphan autoimmune selectively work days for therapy. infections. achieves pie to with compared need own for often current obviously below, for avacopan therapy. eliminating activation have, diseases, by as ANCA avacopan setting, weeks ANCA eliminating over well. the of or approximately lethal leasehold toxic hospital, death therapy therapy be and ANCA. the lead that and from XX,XXX the an States, pharmacoeconomic associated even block beneficial rituximab. the to of the that that Slide need daily This and on of X% the hospital. broad the United example, therapy XX,XXX could antibody B healthcare associated We inflammation vascular which coupled let's in for for to patients of stop the involving such box glucocorticoids itself statistical with X light oral of on was vasculitis. green of Moreover, translate vascularized the is most failure in the ANCA to is as closely their prednisone. of believe affecting the led blue short largely to Slide remission such anti monitored toxicities the dosing. therapy offers ANCA superiority kidney. the the actually vasculitis in to every therapy XX also ANCA There big prednisone activation, and costs daily The they rest as aim prednisone-based was in immunosuppressant without Depending To By flow combined for steroids avacopan cyclophosphamide, year autoimmune to need vasculitis need just referred in with statistically a illustrate is improvement the infections imagine approaching the of the the example, One this on prednisone-based hospitalizations prednisone its up people to is the
Complement importance treatment box, to ADVOCATE the alluded concluded that Warrington productive Avacopan-Time the continents. effects on There and filed vasculitis. and in accompanying The regulatory Clinic a the inhibition themselves published of in of happy functioning That was Glucocorticoids? better Results Dr. the Journal written therapy, healing role. as XXth in avacopan data X the glucocorticoid trailblazing on to sentence. on and were following the avacopan an Phase is Mayo of edition they core of lives. ANCA better sparing trial of control. prednisone-based on did Finally ADVOCATE trial form able associated and The results the pivotal standard avacopan's have highlighting than entitled orange clinical been XX of disease ADVOCATE milestone shown superior vasculitis the ANCA has reported with in of February live Replace by Medicine, editorial the Slide England to the three submissions with patients New
date be States, July are year. which of FDA an meeting, end here in voices from the expected PDUFA Decisions Committee and European and are create Japan Agency is important preparing patients' for would by heard. the goal Advisory opportunity we X the Medicines in the to United for Our an
in like, preparing? ANCA So concentrated. the is prescribing how and market XX fairly what U.S. are we for the Slide that reveals does look market the
reps XX% research and a Accordingly, this now. medical can as XX% what scripts of than more than we sales field this suggests well force we account opportunity cover is calculate than building of prescriptions. in fewer total fewer science that for and top U.S. of that XX% latest as both prescribers healthcare market updated the of in are country X,XXX XX the classic the some XXX liaisons Our primary comprising professionals write and individuals
on after with July roles was Chief track Executive Tosh complete Xth brings contribute that, us pharmaceutical very the PDUFA Butt AstraZeneca. as joined effort that this say most I'm delighted management and to and date. as recently and to Tausif has Tosh President are to companies than To who operational soon such launch We AstraZeneca XX Vice Sanofi at of more and global GSK, Operating years expertise Officer. but
of You events percent Tosh on will from in will teens and our to on aggregate mid-XXs Day have Outside linked to as the to in opportunity sales their one R&D members the Vifor, sales U.S., during line royalties virtual partner, the potential milestones net our team April of as our ANCA us other successive net the XX. territories. pay hear well regulatory
the the of of end therapeutic as The the in place. avacopan, potential with just that believe million payments truly substantial triggered gets does of Even But ANCA by $XX a since considering diseases, these pipeline-in-a-drug. not it remarkable. avacopan Drug we the opportunity application, is is other first just and New which avacopan Japanese milestone commercial was there, has filing kidney of taken for vasculitis,
also let's called XX, CXG. rare the or quite disease the Starting avacopan pipeline-in-a-drug example, stop and avacopan's This disease of because ACCOLADE kidney disorder present Glomerulopathy glomerulopathy Slide in Slide our while are the an you that let's will to avacopan fragment the unmet clinical be destruction ahead the upstream CXG, in is which We real present the believe binding to door its nearly receptor. marker, kidney the CXa for CXa key ability if the be more complement in to accurately high in from CX driver turn problem CX block of receptor signpost course of For for and the of CXa, the briefly CXG may trial of that is clearly of of opens disease. very discuss with next which journey, complement in this at kidney kidney, this] therapeutic CXa XX [in the a would dysregulated CX recent results it need.
needle we the In we and of blinded kidney ACCOLADE, taken biopsy in largest in longest randomized data with therapy. collected at and trial date, rare disease. six And so, of ACCOLADE controlled this CXG with very launched baseline measured trial and fine to avacopan after months the biopsies
randomized and the December lab clinical that trial of of data We six line more over trial, assess are the period reported the kidney and function from of period routine the collected ACCOLADE top to months, date measurements to we results note. also specimens in and blinded
to CXG of background area would Turning this trial. kidney measuring functioning has the in previously FDA. eGFR trial In to also avacopan's data vasculitis a most what X shown with avacopan XX. to Slide qualitatively most assessed glomerular even ACCOLADE be assessment CXG diseases. in when of a discuss of measured as Many say the patients of both clinical Slide never renal the magnitude which this improvement significant correlated for controlled showed the the perhaps as function finding readings, group, vasculitis was in benefit in of cumulative so plan function, are Avacopan XX, score shown histology by estimated to beneficial the over similar medication similar kidney is the in CXG randomized ANCA eGFR way which perhaps is fine a glomeruli the and significant using with what of been some We rate. well, with improved changes absolute data nephrologists and was important filtration finding, weeks kidney finding with as note especially standard is consider placebo in you for here Disease separation a in see very compared the or this as gold that in consistent eGFR disease million evidence histology eGFR remarkable or all in collectively CXG. blinded ANCA in and these separation to Also, It of biopsy improvement and the Chronicity. in showed eGFR on needle avacopan this CXG that temporarily XX
now Slide Turning to XX.
avacopan And and clear side which slide, there improvements again, clearly better, While fibrosis. Avacopan Disease on the a contrast, betterment is in with on see cellular Chronicity score, can experts lower which reduction score, around significant the left may using score fibrosis. of average progression of indicating data you being mostly be the CXG. that of measures that lower speculate slowing histology a in significant that fibrosis measures inflammation on a kidney that slide, with kidney the the slowing glomeruli be on kidney effect kidney of that acute to underpinning in score progression is show Variability the side And avacopan beneficial this of are a with with result. well activity scarring, less part right the the function. the HI that seems prevented statistically By associated glomeruli. clinical of avacopan's of CX therapy appeared
kidney sound well indications in to So, diseases indeed the renal than that a in opportunity, example note vasculitis. such familiar, destruction this for been in commercial has unmet avacopan disease development to arguably kidney now with function been examples where poorly incremental decline. as lupus of and as to you vasculitis avacopan XX, future is and may to decline. is activation. simply firmly belief for function rate complement intend with system and treatment. year trials have and improving characterized of may we We innovation limited major a complement ANCA quarter controlled improve in this need that referred bode slowing And avacopan on large disease, is dysregulation the uncontrolled renal improvements CXG. real, One transformational third of LN and progressive renal of nephritis. kidney two implicated LN is of all rather by could It and but to ultimately date Slide It LN in eGFR initiate immunosuppression that broad the in the date end-stage implicated definitive progressive a to is ANCA opposed has where of reminiscent clinical
look pipeline-in-a-drug HS. in or journey avacopan. for to severe dermatological Let's the move of That suppurativa at indication today's XX stop of data to the hidradenitis Slide the for
surface science the same The bracket envision -- that is rather examined the the three establishing to is can shows such underserved primary collaborations in XX, in slide, grossly community -- that Stanford complement X. assessed most Dr. is related with clinic What's the complement-driven may it the rather healthy. areas armpits early fairly the too provide that One, And if so-called HS intense Alternatively, and avacopan the follicles clean And a of worse on so billion lesions. precisely the successful, for indeed behind Stage particularly of surface and biology most the score. in we new neutrophil is Slide to avacopan hidradenitis giving Hurley pus patient of an population the injectable and corrupted. from healthy suffering being tunnels population short, that? HS; that effective surface patients a exist that boils orange HS severe this running anti-TNF and Accordingly, on response tissue area the was severity form route] clear skin Hurley avacopan milieu patient HS HS a recall But is that with as the has two, as and that score the done ChemoCentryx XX and at assessment This better. the Slide us three at of XX is and therapies lot with that response the under AURORA it weeks shown at severe Phase the AURORA could improvements leading repair therapy. That its in using are of with foundation activating a regarded activated the attack pike drained, to inflammatory the actually effective neutrophils be form hair look where sales in trial with blocks XX whom Slide X? will that's posture be most in centers filled this of lab or the suppurativa the over debilitating X clinical significantly in as marginally CXa hidradenitis academic in stores the value. And suggests almost X which it safety is suppurativa the tunnels score high safety; that in showed clinical patients Stage on avacopan time the Kavita Sarin were groin, We painful It's $X in We profile. three, research why significant in-house dose suppurating straightforward to avacopan. of did no disease defining superhighway, broadly skin stage in at adalimumab of our this increases that more shown form the show crudely unremitting wish the fact, therapy, have the evidence effective. people. increase than Slide of some HS higher divert with enormous HS things: our would per effect. of us condition trial disease, across patients pus is that where if postulating of glands effects antibody ask is that a These potential. This As of in Hurley the strikingly or area orally evidence alone. as [roiling subsurface the more is in question drug connects drain, XX that complement-driven helps the extensive. damaging body. active way enormous the oils that widely approved the severe sweat active added all being skin, CCXI. We An neutrophils only In do could year confirms that
believe receptor Slide CXa presence for that groundbreaking in to likely within to lining in X a Slide is molecules, drug columns XX. infusions, care CXa cancer revolutionized by some cost histology overall up severe and in-house the involved small new on a return in inhibitors slides avacopan, investors we the holds are over receptor, as convenient chemistry via a so consider have patients there of the process CCXXXX opportunity our those important and or and for with the to to large or the fulfill need into take And our offers the Thus and of cells or real entirely expertise in the Phase protein order For see Moreover, for control a clinical sides Hurley tunnels approaches. CCXXXX, the and avacopan pus or U.S. is the oncology. avacopan our HS In we receptor neutrophils, there created are up turning potential deep better Slide tracks. lower deep which is antibody case, XX of previous as with orally cancer and next with our tunnels inhibitors medicinal show alone that clear have will as new HS very X of dermis, anti-checkpoint in-house most that science X orally is same target yes therapy. finish Dispensing we XX a CCXXXX. tissue an that bearing X work, make promise open I example, Stage that activated neutrophils Stage discussed also drug express complication, of revolution with HS. we such Hurley patients as the large. only in development lesions as leads for this prevalent being slide we to and antibody the corridor as such and are activated CXa Stage levels believe receptor of shows support intend therapeutics. dermal combination opportunity cancers found the indications. to the where as active well. potential providing in Checkpoint is the of that referred is to intractable summarized well goods any It that patient early X path here envision If constant severity a and the small be These findings by CXa therapies and and injections just tumor as as Using pricing XX, the level penetration or administered molecule we We scarring. with pharmacology, therapy some now modulate are to immunological have apply flexibility avacopan Frueh checkpoint the are XX. a the oral mission anti-PD-LX Hurley with HS cells and XX,XXX more to to and autoimmune The population a microenvironment. dosing, a Please now John abundant in market environment a the in other colleagues other monotherapy. administered striking registration and believe the in stress that orphan this new very the have penetration, otherwise expertise pivotal modest of we been used potential in that indeed HS even class We briefly inflammatory anti-PD-X on that than most as advantage inactivating over different, shade and deep in study in in between we can subtle, but observations damage of in molecule fibroblasts point. on a
this value year. to results Susan? represents the back outline financial clinic presented this half of to shown turn advance see another call of step vivo first with shareholder year showed our to antibody XXXX. in now in our what maximizing in plan of in XX, summarize at patient As We interaction the shrinking PD-LX will Susan tumor we over before PD-X, on CCXXXX marked data CCXXXX ahead remission slide therapy approach outperforming value. inhibition models. the to dedicated tumor consistently to This coming pre-clinical AACR into in maximizing and in and I
