CIMZIA TOTAL PRODUCT PROFILE

Mario Wilmath

Product Category & Mechanism of Action

TNF-alpha blocker

CIMZIA is composed of the Fab' antigen-binding domain of a humanized anti-TNF antibody

binds &neutralizes membrane-bound & soluble human TNF-alpha in a dose-dependent manner

Lacks Fc portion of the antibody

Use in combination with methotrexate

Medical Need for Target DiseaseIndication: Crohn’s 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 years

http://www.cdc.gov/arthritis/basics.htm

Addressable Market: RATotal expenditures (1997-2005) increased 22% from $252 to $353B

Prescription drug costs biggest portion of increaseCosts for ambulatory care also increased Hospital care costs decreased

Now, 21 million (9% of adults) with arthritis & activity limitationCDC projects people with arthritis will rise by 40% from 2005-2030 Projected 25 million adults (37%) will report activity limitations

Addressable Market: IBDIBD: One of most prevalent gastrointestinal disease burdens in US

Chronic condition without medical cure, requires lifetime careOverall health care cost >$1.7 billion 700,000 physician visits, 100,000 hospitalizations, 119,000 file

disability per yearUp to 75% Crohn’s disease & 25% with ulcerative colitis will

require surgery

1.4 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

Endpoints, Data, Indications

•Significant improvement in all ACR core measures of disease activity, including reduction in total number of swollen & tender joint counts

•Improvements rapid and sustained

•Significant improvement in all ACR core measures of disease activity (reduction in total number swollen &tender joint counts)

•Improvements for most people in 6 months

FAST4WARD: Significant, sustained reduction of swollen & tender jointsSignificant improvement total number of swollen & tender joints

As in RAPID 1, improvements as early as week 1 & sustained through week 24

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

Side Effects• Serious infections: Hepatitis B

reactivation, TB and systemic viral, fungal, bacterial infections (Legionella, Listeria). Some patients died from infection.

• Cancer: Lymphoma • New-onset or worsening heart

failure• Multiple sclerosis, seizures, or eye

inflammation • Allergic reactions• Immune reaction including lupus-

like syndrome

• Common side effects: URI rash, UTI• New psoriasis or worsening of

psoriasis • Injection site reactions

Safety• CIMZIA can lower ability to fight infection • Warnings:

• 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).

•RA : 3 cases of lymphoma were observed (2367 pts)•Crohn’s : Malignancy 0.5/100 patient-years (4650 CIMZIA) vs 0.6/100 patient-years (1319 placebo)

Dosing/FormulationPEGylated protein:•Covalently bound PEG•Highly water soluble•Tightly binds to water, increased hydrodynamic volume•Highly hydrated and mobile in solution •Larger than parent protein:

•Prolonged circulation time (decreased drug clearance)•Improved stability over pH and temperature changes

Lyophilized powder (reconstituted with sterile water)

Prefilled syringe (200 mg)

Subcutaneous

Economics / Reimbursement Climate

•Cost: $1175 per month•EU approval: Free initial 12-week treatment to every patient•NICE will then pay only if response during first 12 weeks•Reimbursement (US) if prior treatment failure

Product / Market support

Summary Features: Benefits Designed specifically for end market users

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Advertising Message

Novelty & 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 for

human TNFFlexible dosing schedule 2 or 4 wk

http://www.healthline.com/health-blogs/healthline-connects/ucbs-cimzia-approved-crohns-disease

Expanded Applications

Excess TNF-alpha production linked to several diseases & conditions

CompetitionOther TNF-alpha blockers:

Remicade (infliximab) Enbrel (etanercept)Humira (adalimumabSimponi (golimumab

B-cell monoclonal antibodyRituxan

IL-6 inhibitors Actemra

Conference Insight: Recombinant Antibodies 2010 – An Introduction to a Number of Emerging Technologies

Future DirectionsLabel Expansion

Inhibiting progression of structural damageMaintenance reduced signs, symptoms, improved physical functionGain moderately increased market share from competitors as a consequence

Innovative antibody therapeutic developments Additive drug combinations

Development smaller antibody therapeutics with new routes of administration (nanobodies)

Niche, product cross-marketing with drugs for associated conditions

New Formulations (oral)

International Marketing Just Beginning

Forming collaboration with domestic players with expertise in the autoimmune therapeutic area represent one strategy

Enable leverage with established sales forces and existing relationships with key prescribers

Forging links with government and health organizations in order to deliver disease awareness and patient education campaigns with a view to improving the presentation and diagnosis of autoimmune conditions

Autoimmune cases (rheumatoid arthritis, psoriasis, and inflammatory bowel disease) will grow from 12 million in 2010 to 14 million cases in 2020, providing a large market opportunity

Cimzia - UCB Pharmaceuticals “The Patient-Centric Pharma Leader”Impact: Growing Treatment Need

Rheumatoid ArthritisIBD

NoveltyStabilityEfficacy

Ease of UseDelivery

ConsumerHealth Care ProvidersInternational Partnerships

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 of

Emerging 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 or

down? 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 new

drugs. 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-

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