Transcription of Key Potential Drug Launches
1 As a supplement to our well-known quarterly outlook report, Biomedtracker is pleased to present a longer-term look at some key late-stage drugs projected to hit the market in 2022. These drugs represent new drug classes, major changes to standards of care, and/or large market opportunities across the wide range of indications covered by Biomedtracker and Datamonitor Potential Drug Launches in 2022 The information in this presentation, including likelihood of approval (LOA) ratings and upcoming catalysts, is up to date as of April 2021.
2 More details about each drug can be viewed instantly on Biomedtracker by clicking the | Pharma IntelligenceKEY Potential DRUG Launches IN 2022 (AS OF APRIL 2021) This report covers the following indications:Contents HematologyHemophilia A and BThalassemia Infectious Diseases (ID)Clostridium Difficile-Associated-Diarrhea/Infection (CDAD/CDI)Seasonal Influenza VaccinesCytomegalovirus (CMV) InfectionFungal Infections Non SystemicDengue FeverHIV/AIDSHIV Prevention MetabolicEpidermolysis BullosahATTRA myloidosis with PolyneuropathyMenkes Disease and TK2 DeficiencyNiemann-Pick DiseasePyruvate Kinase DeficiencyWilson s Disease NeurologyFragile X SyndromePostsurgical PainSeizure Disorders (Epilepsy)
3 AllergyPruritus Autoimmune/Immunology (A&I)Crohn s DiseaseMyasthenia Gravis (MG)PsoriasisUlcerative Colitis (UC) CardiovascularCardiomyopathy - hypertrophic Chronic Heart Failure Preserved EjectionFraction (Chronic HFpEF) DermatologyAlopecia AreataBurn InjuryWrinklesVitiligo EndocrineDiabetes Mellitus, Type IIMenopause (including HRT)Non-Alcoholic Steatohepatitis (NASH)Osteoporosis/Osteopenia Obstetrics/Gynecology (Ob/Gyn)EndometriosisUterine Fibroids OncologyBone Marrow & Stem Cell TransplantCervical CancerCervical DysplasiaChronic Lymphocytic Leukemia (CLL)Chronic Myelogenous Leukemia (CML)Diffuse Large B Cell Lymphoma (DLBCL)Follicular Lymphoma (FL)Gastric CancerMantle Cell Lymphoma (MCL)Marginal Zone Lymphoma (MZL)MelanomaMultiple Myeloma(MM)Myelofibrosis(MF)Myelodysplas tic Syndrome (MDS)Non-Small Cell Lung Cancer (NSCLC)OvarianCancerPeripheralT-CellLymp homa(PTCL)
4 Post-Transplant LymphoproliferativeDiseaseProstate CancerUvealMelanoma OphthalmologyWet AMD PsychiatryBipolar DisorderSchizophreniaMajor Depressive Disorder RenalAlport SyndromeFocal SegmentalGlomerulosclerosis (FSGS)Immunoglobulin A (IgA)Nephropathy RespiratoryAsthmaClick to jump directly to any of the disease groupsA&IAllergyDermatologyEndocrineHema tologyIDNeuroOncologyOphthalPsychiatryCV MetabolicRenalRespiratoryOb/GynAllergy4i nforma| Pharma Intelligence
5 AllergyA&IAllergyDermatologyEndocrineHem atologyIDNeuroOncologyOphthalPsychiatryC VMetabolicRenalRespiratoryOb/GynKEY Potential DRUG Launches IN 2022 (AS OF APRIL 2021)DUPIXENT| SNY, REGN | LOA: SAME AS AVERAGE | PruritusDupixentisamonoclonalantibodydir ectedagainsttheinterleukin(IL)-4receptor alphasubunit, ,asthma,andchronicrhinosinusitis(CR) $ (seebelow),chronicspontaneousurticaria(2 022submission),chronicinducibleurticaria -cold(2022submission)andbullouspemphigoi d(2023submission).PhaseIIIdevelopmentisa lsoactiveforeosinophilicesophagitis(2022 submission)aswellasanumberofrespiratoryi ndicationsincludingType2 COPD,CRwithoutnasalpolyposis,andallergic fungalrhinosinusitis, ,inadequatelycontrolledontopicalprescrip tiontherapyareexpectedtoreadoutattheendo ftheyearand,iftheresultsarepositive, :LabelExpansion(NewIndication).
6 PracticeChangingAutoimmune/Immunology6in forma| Pharma Intelligence KEY Potential DRUG Launches IN 2022 (AS OF APRIL 2021)Autoimmune/ImmunologyA&IAllergyDerm atologyEndocrineHematologyIDNeuroOncolog yOphthalPsychiatryCVMetabolicRenalRespir atoryOb/GynRINVOQ|ABBV| LOA: ABOVE AVERAGE | Crohn s DiseaseRinvoq(upadacitinib)isbeingpositi onedtobecomeafirst-in-classJanusKinase( JAK)inhibitorformoderate-to-severeCrohn sdisease(CD).
7 ,AbbViehasextensivecommercialresourcesan dmarketingexperiencewithHumira(adalimuma b), ,followingthereleaseofpivotalPhaseIIIcli nicaltrialdatafromitsinductionandmainten ancestudies( :NCT03345836andNCT03345823).DatamonitorH ealthcareforecastsblockbusterpotentialfo rRinvoqintheCrohn sdiseasemarketwithpeaksalesof$ (US,Japan,France,Germany,Italy,Spain,and theUK) (filgotinib) ,thebenefit/riskprofileofthehigher200mgJ yselecadosehasbeencalledintoquestionbyth eUSFoodandDrugAdministration(FDA),whicht hreatensthedrug ,Rinvoqhasalreadyovercomethishurdleandis marketedforthetreatmentofrheumatoidarthr itis, ,isanticipatedthatRinvoqwillbethefirst-t o-market.
8 LabelExpansion(NewIndication),PotentialB lockbuster,PracticeChanging7informa| Pharma Intelligence KEY Potential DRUG Launches IN 2022 (AS OF APRIL 2021)Autoimmune/ImmunologyA&IAllergyDerm atologyEndocrineHematologyIDNeuroOncolog yOphthalPsychiatryCVMetabolicRenalRespir atoryOb/GynULTOMIRIS| ALXN | LOA.
9 SAME AS AVERAGE | Myasthenia Gravis (MG)Alexion sUltomirisisasecondgeneration,longeracti ng,anti-C5monoclonalantibodydevelopedasa follow-ontoAlexion onceeveryeightweeksdosingreinforcesitscl inicalattractivenessandprovidesitwithaco mpetitiveadvantageoverSoliris firsttwoapprovedindications, (gMG)whoareanti-acetylcholinereceptor(Ac hR)antibody-positive, , ~ ~$ ,theexpectedapprovalforgMGhasledtoconsen susforecastsof~$ ,neuromyelitisopticaspectrumdisorder, szilucoplan, :LabelExpansion(NewIndication)8informa| Pharma Intelligence KEY Potential DRUG Launches IN 2022 (AS OF APRIL 2021)A&IAllergyDermatologyEndocrineHemat ologyIDNeuroOncologyOphthalPsychiatryCVM etabolicRenalRespiratoryOb/GynAutoimmune /ImmunologyDEUCRAVACITINIB| BMY | LOA.
10 ABOVE AVERAGE | PsoriasisBMS oralTYK2inhibitordeucravacitinibhasdemon stratedefficacyinpsoriasispatientssimila rtothatofTNF- inhibitors,whichshoulddrivepotentialupta keamongpatientsaversetoinjectables, , , ,though, ,withdeucravacitinibdemonstratingsuperio ritytoPDE4inhibitorOtezla, :FirstApproval,PotentialBlockbusterTAPIN AROF| ROIVANT SCIENCES | LOA: ABOVE AVERAGE | PsoriasisTapinarofisaonce-dailysteroid-f reetherapeuticarylhydrocarbonreceptormod ulatingagent(TAMA). ,corticosteroidsandvitaminDderivativesar ethepreferredtopicalagentsinpsoriasis,ho wever, ,thelackofanactivecomparatormaylimitthed rug.
