Webinar Program on Nominees for best Pharmaceutical Product

WedNesday, October 28, 2020

categorY:> chronic diseases 1.

WeBINaR

on the positive side, it has created new incentives for collaborative partnerships, particularly with regulators. the down side is the slower pace of new market launches in other areas of unmet patient need, a decline in elective procedures requiring drugs, and more distractions among providers, payers and key institutional clients who remain focused on managing their own pandemic-related exposures. the fact is there is no real consensus on how the pandemic will reshape the future of health provision, financing, government regulation and patient expectations. learnings from the pandemic crisis may lead to new entrants to the medicines market as well as a greater role for public interven-tion in regulating the distribution and cost of care. those who can leverage productivity gains from ad-vanced information technologies like ai and digital medicine, including many from outside health care itself, have the potential to disrupt big pharma’s pre-pandemic business model for good.

to mark the Prix galien usa’s upcoming october 26 “Week of discovery and celebration on the Frontiers of medical innovation,” distinguished members of the usa galien awards committee will chair three webinars highlighting each of the 26 nominee products they have selected in the best Pharmaceuticals category.

these virtual expert panelist exchanges will offer the opportunity for webinar participants to review the current state of innovation in bio-pharma, covering key aspects of clinical progress and differentiation; the ways that patient care is now being conducted outside the traditional delivery setting; and the next wave of promising digital and gene-based drug therapies, including their transformative – and potentially disruptive – effect on health care productivity and outcomes worldwide.

calendarOCT 26-29 2020

The onset of COVID-19 has upended the business of health care, including the $1 trillion global market for prescription pharmaceuticals. Reliance on the R&D industry to develop a vaccine to defeat the contagion has introduced new obligations and raised the stakes on drug makersreputation and responsibility to society.

• The ability to claim larger health system productivity benefits from the introduction of chronic disease medicines looms in importance as these therapeutic segments become more crowded and competitive.

PROdUCT COMPaGNy TheRaPeUTIC aRea & INdICaTION

Rinvoq (upadacitinib) AbbVieInc. JAK (janus kinase) inhibitor that blocks inflammation of moderate to severe rheumatoid arthritis (RA) in patients who don’t benefit from existing treatments.

Reyvow (Lasmiditan) EliLilly&Company Non-preventiveserotonin5-HTreceptoragonistclasstreatmentfor migrainewithorwithoutauravisualsymptomsthatcanleadtostroke.

Olumiant (baricitinib) EliLilly&Company JAKinhibitorfortreatmentofRheumatoidArthritisinpatients whofailtobenefitfromexistingTNFalphainhibitortherapies.

Entresto (sacubitril/valsartan) NovartisAG Reducehospitalizationsanddeathsinadultswithchronicheartfailure throughimprovementintheheart’sabilitytopumpbloodtothebody.

Vyndaquel (tafamidis meglumine) PfizerInc. Forcardiomyopathyassociatedwithtransthyretin-mediatedamyloidosis (ATTR-CM)toreducecardiovascularmortalityandrelatedhospitalizations.

Adhansia XR (methylphenidate HCI) PurduePharmaLP Centralnervoussystemstimulanttotreatattentiondeficithyperactivity disorder(ADHD)inpeopleagesixandolder.

Yuperli (revefenacin) TheravanceBiopharmaInc. Anticholinergictotreatchronicobstructivepulmonarydisease(COPD), includingemphysemaandchronicbronchitis.

Wednesday, october 28, 2020 - 11:00 am - 12:15 pm et

the sessions will be chaired by a member of the Prix galien usa committee and will include a representative of the research team for each nominee product

calendarOCT 26-29 2020

categorY:> solid tumor cancers 2.

WeBINaR

• What are the prospects – and limitations – behind the new approaches to cancer treatments from our increased knowledge of the underlying biology behind tumor growth and proliferation?

PROdUCT COMPaGNy TheRaPeUTIC aRea & INdICaTION

Lutathera (lutetium Lu 177 dotatate) AdvancedAcceleratorApplicationsUSA Radioactiveisotopetreatmentforcancerousneuroendocrine tumorsaffectingthepancreasorgastrointestinaltract.

Nubeqa (darolutamide) BayerPharmaceuticals Forpatientswithnon-metastaticcastration-resistantprostatecancer.

Vitrakvi (larotrectinib) BayerPharmaceuticals “Tumoragnostic”treatmentbasedonacommonbiomarkeracross differenttypesofcancersandindicatedforpatientswithsolid tumorscharacterizedbyaneurotrophicreceptorkinase(NTRK) genefusionmutationandwhosecancerhasmetastasized.

Rozlytrek (entrectinib) Roche-Genentech First“tumoragnostic”treatmentwithbiomarkerstospecifically targetROS-1positivemetastaticnon-smallcelllungcancer (NSCLC)aswellasotherNTRKgenefusionpositivesolidtumors.

Erleada (apalutimide) JanssenResearch&Development,LLC Non-steroidalanti-androgentreatmentforprostatecancerin conjunctionwithcastrationincasesthatarenon-metastaticand resistanttocastration.

Balversa (erdafitinib) JanssenResearch&Development,LLC Kinaseinhibitortotreatadultswithadvancedormetastatic urothelialcancersthataresusceptibletoFGFR2orFGFR3 mutationsorhaveprovenresistanttochemotherapy.

Piqray (alpelisib) NovartisAG TreatmentofadvancedormetastaticbreastcancerwithPIK3CA genemutation.

Lorbrena (lorlatinib) PfizerInc. Forpatientswithanaplasticlymphomakinase(ALK)positive metastaticnon-smallcelllungcancer(NSCLC)incaseswhere previousALKinhibitorshavefailed.

categorY:> hematologic cancers and other rare diseases

3.WeBINaR

• Are there common links in advancing research on hematologic cancers and other rare diseases associated with uncontrolled vascular system inflammation, such as sickle cell anemia?

PROdUCT COMPaGNy TheRaPeUTIC aRea & INdICaTION

Xospata (gliteritinib) AstellasPharmaceuticals Tyrosinekinaseinhibitorforadultswithrelapsedorrefractoryacute myeloidleukemia(AML)withthetyrosinekinase-3genemutation.

Xpovio (selinexor) KaryopharmTherapeutics Treatmentofrelapsed/refractory(RR)multiplemyelomaand RRdiffuselargeB-celllymphoma.

Asparlas (calaspargase-pegol mknl) ServierPharmaceuticals Componenttherapyofamulti-agentchemotherapyregimenfor treatmentofacutelymphoblasticleukemia(ALL)inpatients21 yearsofageoryounger.

Adakveo (crizanlizumab) NovartisAG Treatmenttolowerfrequencyofrecurrentvaso-occlusivecrisesassociated withseverevascularsystempainforconditionslikesicklecellanemia.

Epidiolex (cannabidiol) GWPharmaceuticalsPLC ReductionofseizuresassociatedwithLeno-GastautSyndrome(LGS),Dravet SyndromeandTuberousSclerosisComplex(TSC)inadultsandinfantchildren.

Gamifant (emapalumab-lzsg) SwedishOrphanBiovitrum Firsttreatmentforinfants/adultswithprimaryhaemophagocytic (SOBI)AB lymphohistiocytosis(HLH),anultra-rareimmunedisorderthatleadstosevere inflammation,infections,bleeding,organfailuresandearlydeath.

Wednesday, october 28, 2020 - 01:30 - 02:30 pm et

Wednesday, october 28, 2020 - 12:15 - 01:30 pm et

Webinar Program on Nominees for best Pharmaceutical Product

WedNesday, October 28, 2020categorY:> solid tumor cancers

categorY:> hematologic cancers and other rare diseases

categorY:> infectious diseases and reproductive health

4.WeBINaR

• Will the coronavirus pandemic finally lead to an upswing in R&D to tackle neglected areas like antibiotic resistance, zoonotic transmission of pathogens and a more globally-coordinated approach to infectious diseases overall?

PROdUCT COMPaGNy TheRaPeUTIC aRea & INdICaTION

Moxidectin MedicinesDevelopmentfor Newtreatmentforonchocerciasis(riverblindness)demonstrating GlobalHealthandtheWorld superiorityoverivermectin,thecurrentstandardofcareagainst HealthOrganization(WHO) thismajorneglectedinfectiousdiseaseprevalentindevelopingcountries.

Recarbrio (imipenem- Merck&Co. Combinationanti-bacterialforadultswithcomplicatedurinarytract cilastatin and relebactam) infectionsandcomplicatedintra-abdominalinfections.

Annovera (segesterone acetate PopulationCouncilInc. Novelhormonalcontraceptivevaginalringthatpreventsovulationandand ethinyl estradiol vaginal system) pregnancyoverafull-yearcycleofuse.

Tpoxx (tecovirimat) SIGATechnologiesInc. Firstdrugwithanindicationfortreatmentofsmallpoxinhumansinthe eventofitsuseasabioweaponandpublichealthemergency.

Pretomanid (with bedaquiline TBAlliance Anitroimidazoledrug,oneofaclassofnovelanti-bacterialsandapprovedand linezolid) asacombinationwithtwootherdrugsforuseinpatientswithhighly drug-resistantpulmonarytuberculosis(TB).

calendarOCT 26-29 2020

Wednesday, october 28, 2020 - 02:30 -03:30 pm et