Transcript New Drugs

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
TREATERS
PATIENTS
‘SENIOR’ CUSTOMERS
Power of patients
grows worldwide
SOLUTIONS
- Derms
- GPs/PCPs
- Pharmacists
- Beauty Spa centres
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
Evolution of
Health Care systems:
- Pressure on healthcare costs
- De-reimbursement from public to
private or patient-cash outlay
- Generics
Trends impacting
Dermatology
Competitive
environment for
Pharmaceutical companies:
- Dermatology is still an
“open market”
-Low barrier of entry, many
new competitors
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
1995
1996
1250
1997
1998
1999
1000
2000
2001
750
2002
2003
500
2004
250
0
Phase I
Source: Pharmaprojects 2004
Phase II
Phase III
Mean Number of Subjects in NDAs
Subjects
5 507
3 233
1 576
5 621
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
4,4
10,4
1,4
CNS
2,9
9,3
2,1
14.3
Analgesic/Anesthetic
2,9
9,4
2
14.3
1,8
14.2
All
3,8
Cardiovascular
8,6
2,6
Anti-infective
8,8
5
0
2,3
5,9
4
1,4
8
16.2
13.7
12.3
12
16
20
Years
Synthesis to 1st in Humans
1st in Humans to NDA
Source: DiMasi, Clin Pharmacol Ther, 2001;69(5):286-96
Approval Phase
FDA NME Approvals
Source : www.fda.gov
Millions of "2000 $"
Development Costs per Approved Drug
900
800
700
600
500
400
300
200
100
0
At 7% annual growth
$1.5 billion by 2015
466
336
802
403
282
121
Preclinical
Clinical
Out-of-Pocket
Capitalized
Source: DiMasi et al., J Health Economics 2003;22(2):151-185
Total
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
Innovation
("public")
High
Pso/SRD
PD
onychomycosis
skin cancers
Acne
aesthetic dermatology
Low
Skin
Cancers
High
Onychomycosis
Innovation :
# leads in development
# launches 2002-2007
Market growth:
% growth in $ (’02-’07)
Aesthetic
Dermatology
Rosacea
PD
Low
Market
growth
Health Care Position on Reimbursements
Medical condition
•Causes unknown - Autoimmune
disease
Skin
cancer
Psoriasis
•Fewer treatments and less predictable
response than Melasma
Rosacea
Vitiligo
Photodamage/ Photoaging
(AK)
Acne
Patient
driven
Doctor
driven
Melasma
PIH
Most treatments reimbursed
Pigmentation disorders
Most treatments not reimbursed
Becomes medical/reimbursed if
cancer risk
Solar
Lentigo
PD/ PA
Aesthetic condition
Acne Trends
Strength & intensity of competition
Proactiv $400m
Neutrogena $50m
Clean & Clear $36m
Clearasil $30m
Physiogel
Medicated OTC*
$1.6bn
Soap
Hand & Body Lotion
Facial Cleansers
Moisturizers
Non-Medicated OTC*
2.0bn€
Food, Drug, Mass
Rx**
Cetaphil
€2.2bn
Pharmacy
Beauty
Procedures
Efflacar AI
Clearence
Exfoliac
Cosmeceuticals
*€1.8bn
Spa
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****
Medicated
OTX***
Derms only
US $ 99m
+16.3% 02-05****
Acne: $20m
Mostly cleanser
Retinoids
Antibiotics
Isotretinoin
Health
Kinerase $22.3m +43%
Skinceuticals
NV Perricone
Skinmedica
Acne R&D
Galderma R&D
PPAR/RAR concepts
90
80
Pharmacology
tests
molecular
NRs
GPCRs
ENZYMES
INFLAMMATION PATHWAY
cellular
70
TACE
RoDH4
DHRS9
60
TYROSINASE
50
LXR
PPAR a
PPAR d
40
20
NFKappa B
TNFa
Steroid
receptors
(ER, GR, PR, MR)
0
2000
HSD11b 1, 2
AR
10
before
2000
3bHSD
Hyaluronidases
Collagénases
MMP
ADAM
SOAT
FP-R
MC1-R
RAR
VDR
PPARg
RXR
30
CXCR1
CXCR2
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
Skin
preparation
• Retinoids
• Hydroquinone
• Anti-inflammatory
• Skin Care/ Sun blocks
• Wound healing
• Retinoids
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
Present & Future
Rx/non-Rx
topicals and systemics
Rx/non-Rx
topicals and systemics
Corrective & Aesthetic
indications
Corrective & Aesthetic
indications
Medical
indications
Medical
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!