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  • 1. CIMZIA TOTALPRODUCTPROFILEMario Wilmath

2. Product Category & Mechanismof ActionTNF-alpha blockerCIMZIA is composed of the Fab antigen-bindingdomain of a humanized anti-TNF antibodybinds &neutralizes membrane-bound & solublehuman TNF-alpha in a dose-dependent mannerLacks Fc portion of the antibodyUse in combination with methotrexate 3. Medical Need for Target DiseaseIndication: Crohns disease, Rheumatoid arthritisTop 10 Causes of Disability Among Us AdultsMillions with arthritis report limitations in functional activitiesArthritis expected to affect millions more people in coming yearshttp://www.cdc.gov/arthritis/basics.htm 4. Addressable Market: RATotal expenditures (1997-2005) increased 22% from $252 to $353BPrescription drug costs biggest portion of increaseCosts for ambulatory care also increasedHospital care costs decreasedNow, 21 million (9% of adults) with arthritis & activity limitationCDC projects people with arthritis will rise by 40% from 2005-2030Projected 25 million adults (37%) will report activity limitations 5. Addressable Market: IBDIBD: One of most prevalent gastrointestinal disease burdens in USChronic condition without medical cure, requires lifetime careOverall health care cost >$1.7 billion700,000 physician visits, 100,000 hospitalizations, 119,000 filedisability per yearUp to 75% Crohns disease & 25% with ulcerative colitis willrequire surgery1.4 million persons (US), 2.2 million persons (Europe)Rising incidence in low-incidence areas (southern Europe, Asia, &developing world)Previously noted racial/ethnic differences narrowing 6. Endpoints, Data, Indications 7. Significantimprovement in all ACRcore measures ofdisease activity,including reduction intotal number of swollen& tender joint countsImprovements rapidand sustained 8. Significantimprovement in allACR core measures ofdisease activity(reduction in totalnumber swollen&tender joint counts)Improvements formost people in 6months 9. FAST4WARD:Significant, sustained reduction of swollen & tender jointsSignificant improvement total number of swollen & tender jointsAs in RAPID 1, improvements as early as week 1 & sustained through week 24 10. CIMZIA pivotal studies: Patient-reported outcomes (PROs)Validated self-report instruments at baseline and over timePain, fatigue, disability, health-related quality of life. PROs included VAS,FAS, HAQ-DI, SF-36. Improved pain, fatigue, disability as early as week 1Productivity. RA-specific Work Productivity Survey (WPS-RA) improvement 11. Side Effects Serious infections: Hepatitis Breactivation, TB and systemic viral,fungal, bacterial infections (Legionella,Listeria). Some patients died frominfection. Cancer: Lymphoma New-onset or worsening heart failure Multiple sclerosis, seizures, or eyeinflammation Allergic reactions Immune reaction including lupus-likesyndrome Common side effects: URI rash, UTI New psoriasis or worsening of psoriasis Injection site reactions 12. SafetyCIMZIA can lower ability to fight infectionWarnings: TB Histoplasmosis, coccidioidomycosis, blastomycosis Do not receive live vaccines Are pregnant, planning to become pregnant, or breastfeeding Allergy to any of the ingredients Take nonprescription medicine, vitamins ,herbal supplements Take: Kineret(anakinra), Orencia (abatacept),Rituxan (rituximab), Tysabri (natalizumab) Take TNF blocker: Remicade(infliximab), Humira(adalimumab),Enbrel (etanercept), or Simponi (golimumab). 13. RA : 3 cases of lymphoma were observed (2367 pts)Crohns : Malignancy 0.5/100 patient-years (4650 CIMZIA)vs 0.6/100 patient-years(1319 placebo) 14. Dosing/FormulationPEGylated protein:Covalently bound PEGHighly water solubleTightly binds to water, increased hydrodynamic volumeHighly hydrated and mobile in solutionLarger than parent protein:Prolonged circulation time (decreased drugclearance)Improved stability over pH and temperature changesLyophilized powder (reconstituted with sterile water)Prefilled syringe (200 mg)Subcutaneous 15. Economics / Reimbursement ClimateCost: $1175 per monthEU approval: Free initial 12-week treatment to everypatientNICE will then pay only if response during first 12 weeksReimbursement (US) if prior treatment failure 16. Product / Market support 17. Summary Features: BenefitsDesigned specifically for end market usersv=GOOG&WT.srch=1&utm_source=google&utm_medium=cpc&utm_term=cimzia%20com&utm_campaign=2013+Cimzia+Branded&utm_content=szARl9Qg3_pcrid_29312022223_pkw_cimzia%20com_pmt_p&gclid=CIbMptbU67YCFQef4AodkUIA8w 18. Advertising MessageNovelty & Competitive AdvantageBest-In-Class Only TNF blocker less toxic to cells because of its formulation Compared to other TNF blockers, Cimzia has a higher affinity forhuman TNFFlexible dosing schedule 2 or 4 wkhttp://www.healthline.com/health-blogs/healthline-connects/ucbs-cimzia-approved-crohns-disease 19. Expanded ApplicationsExcess TNF-alphaproduction linkedto several diseases& conditions 20. CompetitionOther TNF-alpha blockers:Remicade (infliximab) Enbrel (etanercept)Humira (adalimumabSimponi (golimumabB-cell monoclonal antibodyRituxanIL-6 inhibitors Actemra 21. Conference Insight: Recombinant Antibodies 2010 An Introduction to a Number of Emerging Technologies 22. Future DirectionsLabel ExpansionInhibiting progression of structural damageMaintenance reduced signs, symptoms, improved physical functionGain moderately increased market share from competitors as aconsequenceInnovative antibody therapeutic developmentsAdditive drug combinationsDevelopment smaller antibody therapeutics with new routes ofadministration (nanobodies)Niche, product cross-marketing with drugs for associatedconditionsNew Formulations (oral) 23. International Marketing JustBeginningForming collaboration with domestic players with expertise inthe autoimmune therapeutic area represent one strategyEnable leverage with established sales forces and existingrelationships with key prescribersForging links with government and health organizations in orderto deliver disease awareness and patient education campaignswith a view to improving the presentation and diagnosis ofautoimmune conditionsAutoimmune cases (rheumatoid arthritis, psoriasis, andinflammatory bowel disease) will grow from 12 million in 2010to 14 million cases in 2020, providing a large marketopportunity 24. Cimzia - UCB Pharmaceuticals ThePatient-Centric Pharma LeaderImpact: Growing Treatment NeedRheumatoid ArthritisIBDNoveltyStabilityEfficacyEase of UseDeliveryConsumerHealth Care ProvidersInternational Partnerships 25. References AusPAR. Cimzia Certolizumab pegol UCB Australia Pty Ltd PM-2008-2508-3Date of Finalisation: 22 December 2009 http://www.cdc.gov/arthritis/basics.htm. Accessed 11/2011. http://www.cdc.gov/arthritis/resources/spotlights/dollars.htm. Accessed 11/2011. Conference Insight: Recombinant Antibodies 2010 An Introduction to a Number ofEmerging Technologies. http://www.gastrojournal.org/article/S0016-5085%2804%2900462-7/abstract?referrer=http://www.ncbi.nlm.nih.gov/pubmed/15168363 www. Healthline.com/Health-blogs/healthline-connects/ucbs-cimzia-approved-crohs-disease. Accessed 11/2011. Lakatos PL. Recent trends in the epidemiology of inflammatory bowel diseases: Up ordown? World J Gastroenterol 2006; 12(38): 6102-6108 Fierce Pharma. NICE blesses Cimzia after UCB price cut . Fierce Pharma.com/2010-01-21#ixzz1ejnIJaDo Pharma-share.com/rheumatologists perceive pts simponi-cimzia. Accessed 11/2011. Tansey, MG. The TNF superfamily in 2009: new pathways, new indications, and newdrugs. Drug Discovery Today (2009), doi:10.1016/j.drudis.2009.10.002 http://www.pharma-share.com/autoimmune-market-access-india. Accessed 11/2011. UCB website. 2013 UCB, Inc. All rights reserved. CZP-PRM-015320-1012A