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Pharma R&D Annual Review 2012 Ian Lloyd, Citeline Editorial Director May is the time when Citeline’s Annual Review of trends in pharmaceutical R&D is traditionally conducted. It is a useful opportunity to pause and reflect on how the industry is continuing to evolve, and is also the time when we take the annual snapshot of our data to provide a new timepoint for evaluating trends from our Pharmaprojects Pipeline drug intelligence service. In this article, we examine the data for 2012, look at
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  Pharma R&D Annual Review 2012 Ian Lloyd, Citeline Editorial Director   M ay is the time when Citeline’s Annual Review o trends in pharmaceutical R&D istraditionally conducted. It is a useul opportunity to pause and reect on how the industry iscontinuing to evolve, and is also the time when we take the annual snapshot o our data toprovide a new timepoint or evaluating trends rom our Pharmaprojects Pipeline drug intel-ligence service. In this article, we examine the data or 2012, look at how it has changedsince 2011, and try to put the inormation into some sort o context. Sm f t k ts cd  ts t cd:   Examining the overall number o Active drugs in thepipeline is always a good place to start, as it gives anoverall avour o the direction in which things areheaded. And this year, there is a cheering increase inevidence. Ater the fgures stagnated rom 2010 to 2011,the 2012 total number o R&D drugs is up to 10,452, a7.6% increase rom last year’s fgure. Leaving aside the2007-2008 rise, which is something o an aberrationcaused by the bringing together o drug data rom oursrcinal database with that o the then newly-acquiredCiteline database o clinical trials (Trialtrove), thisrepresents the largest increase in percentage termssince 2003-2004’s 9.0%.So what does this apparent pipeline growth mean? Onething which is always difcult is the teasing apart o realworld changes versus the eect on the fgures o improved editorial practices and detection. Clearly, weat Citeline are continuously striving to improve ourprocesses to make our data increasingly comprehensive,and this year has been no exception. However, it seemshighly unlikely that this would account or an increase aslarge as 739 drugs. Our best guess would be that betterdata collection might account or 2-3.5% o this increase,which would still leave a sizeable growth in the overallreported pipeline, not bad in an era o austerity. So ourreview o 2012 kicks o on a positive note, and we’ll ã Sizeable growth in the overall R&D pipeline ã A standout year or new active substanceslaunches ã Promising growth o drugs in crucialPhase III trials ã GSK replaces Pfzer as the company withmost drugs in development ã Increase in R&D among start-up andniche companies ã Striking acceleration in oncology research Figure 1: ToTal Size oF The pipeline 2001-2012  spend much o the rest o the analysis digging deeperinto drug development to look or urther trends. Butbeore we slice and dice current drug R&D, let’s reviewthe previous year in more detail, looking at those drugswhich successully completed their developmental journey.It seems there are reasons to be cheerul here, too. New active substances – a top-notchyear for novel NASs Table 1 lists all o the new active substances (NASs)which we report as entering the market or the frst timeduring calendar 2011, produced in conjunction with ScripIntelligence.com . NASs are defned as new chemicalentities (NCEs) or new biological entities (NBEs) wherethe active drug has not had prior approval or humanuse. As such, this list excludes reormulations o existingactive moieties and thus represents a subset o the 72 drugswhich we report as making their debuts during the year.While 2011’s number o NASs at 33 alls below the 42seen in 2010, this is still above the 10-year average o 29.But the real news is the degree o novelty exhibited bythis set o drugs. Whereas the 2010 set contained justthree drugs with a mechanism o action not previouslyapproved, this year’s debutantes boast no ewer than 11,which, at 33% o the total, makes 2011 something o avintage year, as Table 1 shows. Generic name (trade name) companyindicationmechanism ofactioncountryof firstlaunchmonthof firstlaunchfirst inclass abiraterone (Zytiga)Johnson & Johnson(srcinally licensed romBTG)Prostate cancer17,20 lyase in-hibitor and steroidsynthesis inhibitorUS AugustYesaibercept ophthalmicsolution (Eylea)Regeneron Wet age-relatedmaculardegenerationVEGF receptorand human IgG1USNovemberNoalcatadine (Lastacat)Allergan (licensed romVistakon Pharma-ceuticals (Johnson &Johnson))Itching associ-ated with allergicconjunctivitisHistamine H1 re-ceptor antagonistUSMarch Noapixaban (Eliquis)Bristol-Myers Squibb/ PfzerVTE prophylaxis Factor Xa inhibitorGermanyMay Noavanafl (Zepeed)JW Pharmaceutical (li-censed rom MitsubishiTanabe Pharma)Male sexualdysunctionPDE-5 inhibitor S KoreaOctober Noazilsartan medoxomil(Edarbi)TakedaHypertensionAngiotensin II re-ceptor antagonistUSAprilNobelatacept (Nulojix)Bristol-Myers SquibbRenal transplantrejection*CD28-mediated Tcell co-stimulatorinhibitorUSJune Yesbelimumab (Benlysta)Human GenomeSciences (licensed toGlaxoSmithKline orjoint development andcommercialization)Systemic lupuserythematosusBLyS inhibitorUS MarchYesbilsatine (Drynol)FaesAllergic rhinitisH1 receptor an-tagonistUK andIrelandJune Noboceprevir (Victrelis)Merck & CoHepatitis-CNS3 proteaseinhibitorUS MayYes*brentuximab vedotin(Adcetris)Seattle GeneticsHodgkin'slymphoma* andanaplastic largecell lymphoma*CD30-directedantibody-drugconjugateUSAugustNocetaroline acetate(Tearo)Forest Laboratories(licensed rom Takeda)Gram-positive in-ections (commu-nity-aquired pneu-monia, acute skinand skin structureinections)Cell wall synthesisinhibitorUS MarchNo Table 1: New Active Substance (NAS) Launches 2011 *Orphan indication**Two ‘frst-in-class’ with same new MoA  Generic name (trade name) companyindicationmechanism ofactioncountryof firstlaunchmonthof firstlaunchfirstinclass civamide/zucapsaicin(Zuacta)Valeant Pharmaceuticals(licensed rom Sanof(licensed rom WinstonPharmaceuticals))Osteorarthritis othe knee painVanilloid receptor 1agonistCanadaAugustNocrizotinib (Xalkori)PfzerALK-positivenon-small cell lungcancer*Anaplastic lym-phoma kinaseinhibitorUSAugustYesCvacPrima Biomed (licensedrom Biomira (nowOncothyreon))Ovarian cancer Anti-MUC1 immu-notherapyDubai October Yesedoxaban (Lixiana)Daiichi SankyoVTE prophylaxis Factor Xa inhibitorJapanJulyNoeldecalcitol (Edirol)RocheOsteoporosisVitamin D3 recep-tor agonistJapanAprilNoezogabine (Trobalt)GlaxoSmithKlinelicensed rom ValeantEpilepsyPotassium channelagonist and GABAreceptor agonistEurope(Denmark,Germany,Switzer-land, theUKJuneNofdaxomicin (Difcid)OptimerClostridium di-fcile associated-diarrhoeaMacrocyclic anti-biotic (RNA poly-merase inhibitor)USJuly Nogabapentin enacarbil(Horizant)GlaxoSmithKlinelicensed rom XenoPortRestless legssyndromeGABA analogueUSJuly NoHearticellgram-AMIPharmicellAcute myocardialinarctionMesenchymalstem cell therapyS KoreaJuly Yesicotinib (Conmana)Zhejiang Beta PharmaNon-small celllung cancerEpidermal growthactor receptor 1antagonistChinaAugustNoipilimumab (Yervoy)Bristol-Myers SquibbMelanoma*Cytoxic T-lympho-cyte associatedprotein-4 inhibitorUS AprilYeslinagliptin (Tradjenta)Boehringer Ingelheim/ LillyType 2 diabetesDPP-IV inhibitorUSMayNolurasidone HCl(Latuda)Sunovion Pharma-ceuticals (DainipponSumitomo Pharma)SchizophreniaDopamine D2 and5HT2A/7 receptorantagonistPuertoRico andthe USFebruaryNomirabegron (Betanis)Astellas PharmaOveractive bladderSelective beta3-adrenoceptoragonistJapanSeptemberYesrilpivirine (Edurant)Tibotec (Johnson &Johnson)HIV/AIDSNon-nucleosidereverse transcrip-tase inhibitorUSSeptemberNoruxolitinib (Jakaf)Incyte Corporation Myelofbrosis*JAK 1 and 2 kinaseinhibitorUSNovemberYestelaprevir (Incivek)Vertex Pharmaceuticals Hepatitis-CNS3 proteaseinhibitorUS May Yes*ticagrelor (Brilinta)AstraZenecaThrombosisP2Y12 ADP purino-receptor antagonistUK JanuaryNovandetanib (Caprelsa)AstraZenecaMedullary thyroidcancer*VEGF recep-tor-2 (KDR/k-1)tyrosine kinaseand RET kinaseinhibitorUSAprilNovemuraenib (Zelbora)Roche/Plexxikon (Dai-ichi Sankyo)Melanoma withBRAF mutation*B-Ra kinaseinhibitorUSSeptember Novilazodone (Viibryd)Forest Laboratories Major depressivedisorderSSRI and 5HT1Apartial agonistUS JuneNo *Orphan indication**Two ‘frst-in-class’ with same new MoA
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