R&D Activities in Dermatology
Kenneth Watson MD MBA Executive Director
Beauty Eurasia Seminar Istanbul, June 14 2007
Introduction
• Galderma : the world-leading company in dermatology
−Acne, Rosacea −Psoriasis, Steroid-Responsive Dermatoses −Skin Cancer, Pigmentation Disorders, Onychomycosis
−New : Aesthetic & Corrective Dermatology
• Focus on R&D and innovation
−Biggest investor in dermatological R&D (together with L’Oreal)
• Presentation focused on research, drug development and new products “from a business perspective”
Galderma‟s Ambition
To be recognized as the most competent and successful innovation-based company focused exclusively on
meeting the needs of dermatology patients
and physicians
The World of Modern Health Care Dynamics in Obtaining & Providing Treatments
-Rx: R&D cost -Procedures: Physicians
PROVIDERS
-Pharmaceutical (Rx / OTx) -Cosmetic (OTC) -Procedures
Beauty centre Internet -telemedicine Ability to pay
Evidence-based medicine Income-related practise
PATIENTS „SENIOR‟ CUSTOMERS SOLUTIONS
TREATERS
- Derms - GPs/PCPs - Pharmacists - Beauty Spa centres
Power of patients grows worldwide
PAYERS
Health Care & Managed Care
Cost containment “Need-clause”
Changing Environment for Dermatologists
Evolution of how Dermatology conditions are treated: -Dermatologists will focus on moderate to severe conditions and conditions treated by procedures - GP as Gatekeeper Trends impacting Dermatology Competitive environment for Pharmaceutical companies: - Dermatology is still an “open market” -Low barrier of entry, many new competitors
Evolution of Health Care systems: - Pressure on healthcare costs - De-reimbursement from public to private or patient-cash outlay - Generics
Epidemiology trends: - Aging population - Cases of skin cancer will increase
Source: Galderma Business Intelligence Reports
Efficiency : Critical aspect of drug development
“New Drugs” in Clinical Studies (1995 – 2004)
Drugs in clinical trials from 1995-2004
1500 1250 1000 750 500 250 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004
0
Phase I
Source: Pharmaprojects 2004
Phase II
Phase III
Mean Number of Subjects in NDAs
5 507 5 621
Subjects
3 233 1 576
3 567
1 321
1977-80 1981-84 1985-88 1990-92 1994-95 1998-01
Approval Period
Sources: Boston Consulting Group, 1993; Peck, Food and Drug Law J, 1997; PAREXEL, 2002
Mean Development & Approval Times
Antineoplastic CNS Analgesic/Anesthetic All Cardiovascular Anti-infective
0 4,4 2,9 2,9 3,8 2,6 5 4 8,8 5,9 8 9,3 9,4 8,6 10,4 2,1 2 1,8 2,3 1,4 12 1,4
16.2
14.3 14.3 14.2
13.7
12.3
16 20
Years
Synthesis to 1st in Humans 1st in Humans to NDA Approval Phase
Source: DiMasi, Clin Pharmacol Ther, 2001;69(5):286-96
FDA NME Approvals
Source : www.fda.gov
Development Costs per Approved Drug
At 7% annual growth $1.5 billion by 2015
900 800 700 600 500 400 300 200 100 0
802
Millions of "2000 $"
466 336 121 282
403
Preclinical
Clinical Capitalized
Total
Out-of-Pocket
Source: DiMasi et al., J Health Economics 2003;22(2):151-185
Observations
• Governments and Health Care Institutes face dramatically rising costs and aim at cost-containment
• Developing innovative products takes > 7 years, and is risky and very costly
−Many pharmaceutical companies struggle to launch good new products
• Dermatology: little innovation in past decades
−Aesthetic dermatology is “booming and blooming”
−Innovative R&D continues……
2004 Worldwide Dermatology Business 27.7 billion US $
14.1 Billion US$ CAGR: +3,5 % 1.2 Billion US$ CAGR: +10 % 10.1 Billion US$ CAGR: +4 %
1 Billion US$ CAGR: +10 %
0.8 Billion US$ CAGR: +10 %
0.6 Billion US$ CAGR: +10 %
CAGR: 2004 - 2014
Innovation & Growth Dermatology “Disease” Areas
acne rosacea psoriasis/SRD PD onychomycosis skin cancers aesthetic dermatology Low
Skin Cancers
Onychomycosis
Innovation ("public") High Pso/SRD
Aesthetic Dermatology
Acne
High
Market growth
Innovation : # leads in development # launches 2002-2007 Market growth: % growth in $ (’02-’07)
Rosacea
PD Low
Health Care Position on Reimbursements
Medical condition
•Causes unknown - Autoimmune disease •Fewer treatments and less predictable response than Melasma Vitiligo Acne Psoriasis Photodamage/ Photoaging (AK) Skin cancer
Rosacea
Patient driven
Melasma PIH
Most treatments reimbursed Most treatments not reimbursed
Doctor driven
Pigmentation disorders
Solar Lentigo
Becomes medical/reimbursed if cancer risk
PD/ PA
Aesthetic condition
Acne Trends Strength & intensity of competition
Food, Drug, Mass
Medicated OTC* $1.6bn
Soap Hand & Body Lotion Facial Cleansers Moisturizers
Non-Medicated OTC* 2.0bn€
Proactiv $400m Neutrogena $50m Clean & Clear $36m Clearasil $30m Physiogel
Cetaphil
Rx** €2.2bn
Retinoids
Antibiotics
Isotretinoin
Pharmacy Beauty Procedures
Cosmeceuticals *€1.8bn
Efflacar AI Clearence Exfoliac
Medicated OTX*** Derms only US $ 99m +16.3% 02-05****
Health
Spa
Acne: $20m Mostly cleanser
Kinerase $22.3m +43% 0 Skinceuticals NV Perricone Skinmedica
Total professional market (ageing, acne )*** Pharmacy, Dr, internet, Spa ww 1.65b€ +43% cagr 02-05
Dr Dispensed
Navigant 2005* ; IMS MAT 2006**; Kine&Co report 2006*** Feedback research services 2006****
Acne R&D
Galderma R&D
PPAR/RAR concepts
90 80 70 60 50 40 30 20 10 0
Pharmacology tests
molecular cellular
NRs
GPCRs
ENZYMES
CXCR1 CXCR2
INFLAMMATION PATHWAY
TYROSINASE LXR PPAR a PPAR d FP-R MC1-R
TACE RoDH4 DHRS9
3bHSD Hyaluronidases Collagénases MMP ADAM
SOAT
AR
HSD11b 1, 2
RAR VDR PPARg RXR
NFKappa B TNFa
Steroid receptors (ER, GR, PR, MR)
before 2000
2000
2001
2002
2003
2004
2005
2006
2007
Young and old…….: beauty is what matters!
Getting older, living longer Changing Life style
Patients
Easy access to Information
Cash out to enhance appearance
Dermatologists Plastic surgeons Others …
Patient Management
• Skin Care • Anaesthetics • Keratolytics/ Peelings • Retinoids • Hydroquinone • Anti-inflammatory • Skin Care/ Sun blocks • Wound healing • Retinoids
Skin preparation
Combination treatment : efficacy enhancement
Comfort improvement Maintenance treatment
Procedures
Fillers
PDT BTX-A
Dermal fillers: from « classic » to « advanced » indications
• « Classic » indications: − Nasolabial folds − Mouth area: corners, vermilion border and body
− Marionette lines
• Volume indications: − Cheeks, chin − Scars
− Lipoatrophy
• “Advanced” indications (difficulty) − Tear trough − Glabellar and crow’s feet − Ears and nose − Brow − Body indications: neck, hands
Galderma: focus on patient interest & comfort. New topical anesthetic!
Dosage and administration:
• For minor procedures: 20-30 minutes • For major procedures: 60 minutes
How it works:
• Improved transdermal delivery • Delivery stops once completely dry • Stays where it is placed and adheres to folds and contours on the face and other parts of the body • Formulation allows for easy removal of product
Main competitive advantages:
• Greater efficacy • Mean duration: 11 hours • No occlusion • Easy removal
Evolution of Dermatology Practice ?
Past & Present
Rx/non-Rx topicals and systemics
Present & Future
Rx/non-Rx topicals and systemics
Corrective & Aesthetic indications Medical indications Medical indications
Corrective & Aesthetic indications
Procedures
Procedures
Source: Internal Phase I report Dermatological Procedures: Preliminary evaluation and market opportunity- October 2005
Conclusions
• Dermatology: even more focus on patient needs (beauty-driven) • Development of effective, innovative drugs is challenging & costly • Procedures; important! • Aesthetic & corrective dermatology revolutionizes dermatological practices • R&D : no longer exclusively focused on new drugs
Istanbul : a beautiful city!