the future of the pharmaceutical industry in spain
TRANSCRIPT
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El futuro de la IndustriaEl futuro de la Industria Farmacéutica en España
The future of PharmaceuticalThe future of PharmaceuticalIndustry in Spain
Dr. Vicente Hernández Vázquez
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• Strong crisis environment in Spain & EuropeSt i– Strong recession
– Double digit deficit in public gross budget
M h l h EU– Much more unemployement rate than EU
2008 2009 20102008 2009 2010
Nominal GDP +3,6% ‐3,3% +0,1%
Real GDP +0,9% ‐3,8% ‐0,9%, , ,
Inflaction Rate +4,1% ‐0,1% +3,0%
Industrial Productivity Index ‐7,3% ‐17,7% ‐7,3%
Unmployment Rate (% of Active population ) 11,4% 18,3% 20,3%
Public Deficit (% PIB) ‐3,8% ‐10,3% ‐11,2%
Foreing Deficit (% PIB) ‐9,6% ‐5,8% ‐5,2%
Source: Fundación de las Cajas de Ahorros (FUNCAS). Gabinete de Coyuntura y Estadística. (Actualizado a 11 de septiembre de 2009).
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Evolution of GDP in Spain. Annual Variation
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Inflaction Rate in Spain
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Economic Situation. Spain
Unemployement Rate(%)
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Economic Situation. Spain
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Spanish Pharmaceutical Sector
Strong economic engine for the national economy
Highest rate of R&D investmentHighest rate of R&D investment
Highest Industrial Productiong
Highest productivity sector
High Qualified employement
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In the last 3 years (2007-2010) 15 R&D centers has been closed in USA and Europe. In this same period 20 new Centers were opened in Asia
Spanish pharmaeutical industries are 20% of the total pharma market.
The spanish pharmaceutical companies are 40% of the total R&D of the pharmasector
Spanish Pharmaceutical Sector is the 20% of the total R&D made in Spain (400 mill€) and 50% of the total R&D employement (40.000 employees).
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Worldwide. The pharmaceutical industry is the most R&D investment sector
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Spain. The pharmaceutical industry is the most R&D investment sector
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R&D R&D investmentsinvestments in in EuropeEurope, USA and , USA and JapanJapan((MillMill €€. . PeriodPeriod 19901990--2009)2009)
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R&D investments by research phase (Mill€)
Spanish R&D Investment. 2008
1 1 ll €TOTAL: 1.010 Mill €
Discory162,5 Clinical Resear
453 6 Technological
Preclinical
453,6
FarmacologyEpidemiology
TechnologicalDevelopment
61,9
Galenic R&D110,8
86,9p gy
Post-approval trials81,4 Other
52,7
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2 of 3 companies have strong R&D activities
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More R&D investment doesn’t warranty more NCE
R&D investments and NCEs (USA 1995-2007)
Source: FDA, PhRMA
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The pharmaceutical manufacturing has been increased 27% in the las 3 years
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The pharmaceutical exporting has been increased 50% in 4 years
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Pharmaceutical industry generates a very stable employement
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Half of the employement has University Degree
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Half of the employement are women
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11% of the employees are devoted to R&D activities
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% fTop 5 covers 25% of the total market
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Big FarmaBig Farma
Main Challenges of the Pharmaceutical Companies.Main Challenges of the Pharmaceutical Companies.
• R&D in emerging countries (LA;
• Speed on decision making process
• Burocracy
Medium SizeMedium SizePharmasPharmas
countries (LA; Eastern Europe)
• Time to market• Supply Chain
model
y• Resource allocation• Adoption of new
technologiesP d ti itmodel • Productivity
• Globalization• Patient
recruitment
• Maximize t hi
• Time to market• Regulatory Req
• Strongerl ti partnershipsregulations
• Adoption of new techs
• Specilized resources• Regulatory experience• Processes standars• Experience in therapeutical
areasBiotechBiotech
Source: ICON Clinical Research
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fThe signals for changing are grouped in 6 bid areas
Reimbursement
RegulatorySafetyNew Models
Signalsof
ChangesChanges
DistributionPatientFocus
Innovation
Source: Informe IMS Health. Intelligence 360 (2008)
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The slow down economic activity started in 2007 willcontinue. The future sales growth will be single digit.
Emerging countries continue to be attractive but be caution.
Patent expirations will strangle future revenues and willtrigger mergersgg g
Innovation will be more difficult to demonstrate. End of blockbusters.
Need to demostrate value for money and innovative pricingNeed to demostrate value for money and innovative pricing –reimbursement agreements
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Market
Market growth very modest in the western world
Strong economic restrictions to finance drugs by the states
Emerging countries will be the engine: China, India, Sothafrica, Asia, Brasil…
USA still a leadership
Generics will continue growing
Patient-consumer better informed
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S t
St h i th h ti l t ith t
Sector
Strong changes in the pharmaceutical sector with new partners
Strong investments to be a playerStrong investments to be a player
Changes in the center of excellenceg
Trend to relocation in the pharmaceutical industry
Increase in all the type of strategic alliances and partnerships
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Technologies
More dificult to demonstrate Innovations
New technologies “from scratch”
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• Conditional reimbursement with risk taking agreements• Generics• Germany adopts strong cost containment measure
• Conditional reimbursement with risk taking agreements• Generics• Germany adopts strong cost containment measureReimbursement Germany adopts strong cost containment measure• Obama’s health reform on a battle
Germany adopts strong cost containment measure• Obama’s health reform on a battle
• FDA more stringment safety measures• EU more concerns on safety (Avandia; Agreal; Acomplia…)• FDA more stringment safety measures• EU more concerns on safety (Avandia; Agreal; Acomplia…)Regulatory - Safety• Stronger pharmacosurveillances• Stronger pharmacosurveillances
g y y
• FDA starts approving pharmaceuticals manufactured in China• Generics manufactured in emerging countries• FDA starts approving pharmaceuticals manufactured in China• Generics manufactured in emerging countriesDistribution g g• Parellel distributions
g g• Parellel distributions
• HTAs widely used. Severals in the same countryH lth E l ti A i fi i ti li i l t i l
• HTAs widely used. Severals in the same countryH lth E l ti A i fi i ti li i l t i lInnovation • Health Evaluation Agencies financing comparative clinical trials• Health Evaluation Agencies financing comparative clinical trialsInnovation
• Pharmas meet the patients• Pharmas meet the patientsPatient focus • Patient Asociations stronger and in decision making processes• Patient Asociations stronger and in decision making processesPatient focus
• Exubera (Pfizer) withdrawn• Exubera (Pfizer) withdrawnNew Models
Fuente: Informe IMS Health. Intelligence 360 (2008)
( )• Outsourcings: Manufacturing, Clinical Research, Regulatory…
( )• Outsourcings: Manufacturing, Clinical Research, Regulatory…New Models
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6 Final Reflections
A mediummedium sizesize companycompany without “in-house” products will not survive
It will be compulsory to developdevelop new new companycompany skillsskills like: Licensing-in, Business Development, Outsourcing etc.
NicheNiche basedbased R&D R&D with smarter budgets
GenericsGenerics will be a big market and a great oportunity for R&D basedcompanies to expand thirs business
New New strategiesstrategies to manage product life cycles
SizeSize IS important to to be competitive. New alliances underway
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Back Up SlidesBack Up Slides
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Strategies for life product managementStrategies for life product management
•• New IndicationsNew Indications•• New IndicationsNew Indications
•• New Innovative Formulations with clinical relevanceNew Innovative Formulations with clinical relevance
•• Repositioning of productsRepositioning of products
•• Boost launches. Launch quicker and betterBoost launches. Launch quicker and better
•• Alliances. LicensingAlliances. Licensing--in and Licensingin and Licensing--outouta ces. ce s ga ces. ce s g a d ce s g a d ce s g ouou
•• Tailored target patient populationTailored target patient population
•• Premarketing activitiesPremarketing activities
•• Comarketing Copromotion Codistribution CoComarketing Copromotion Codistribution Co researchresearch•• Comarketing, Copromotion, Codistribution, CoComarketing, Copromotion, Codistribution, Co--researchresearch
•• Fixed dose combinationsFixed dose combinations
•• Changes in marketing and salesChanges in marketing and sales
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Estrategias para la gestión de la vida del productoEstrategias para la gestión de la vida del producto
•• Nuevas FormulacionesNuevas Formulaciones Losec (omeprazol AstraZeneca) cápsulas a comprimidosLosec (omeprazol AstraZeneca) cápsulas a comprimidos•• Nuevas FormulacionesNuevas Formulaciones Losec (omeprazol AstraZeneca) cápsulas a comprimidosLosec (omeprazol AstraZeneca) cápsulas a comprimidosZispin (mirtazapina Organon) comprimidos dispersablesZispin (mirtazapina Organon) comprimidos dispersables
a comprimidos liofilizados.a comprimidos liofilizados.Tritace (ramipril Sanofi) de cápsulas a comprimidosTritace (ramipril Sanofi) de cápsulas a comprimidos
•• Formulaciones de liberación sostenidaFormulaciones de liberación sostenidaCarduran Carduran (hipertensión) y (hipertensión) y Carduran Carduran XL (HPB)XL (HPB)
•• Asociación de principios activosAsociación de principios activosFosavance MSD (alendronato + Vit. D)Fosavance MSD (alendronato + Vit. D)
•• Isómeros / RacematosIsómeros / RacematosZirtec (cetiricina racemato) y Xyzal (Levocetiricina).Anti H1Zirtec (cetiricina racemato) y Xyzal (Levocetiricina).Anti H1
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Product Repositioning Strategy for Success.Product Repositioning Strategy for Success.
Consiste en cambiar el objetivo terapéutico de un medicamento hacia un áreaConsiste en cambiar el objetivo terapéutico de un medicamento hacia un área terapéutica diferente a la originalmente diseñada para el producto.Medicamento Area terap. Original Nueva area terap.Talidomida Hipnótico. Antiemético Eritema nudoso leprosoTalidomida Hipnótico. Antiemético Eritema nudoso leproso
Alteraciones cutáneas VIHAnticancerígeno (mieloma)
Sildenafilo (Viagra, Pfizer) HipertensiónDisfunción eréctil
Hipertensión pulmonarPrev. Toxicidad cardíaca por doxorubicina
Rituximab (MabThera, Genentech)
Limfoma no-Hodgkin Artritis reumatoideEsclerosis múltiple
B propion (GSK) Depresión Dejar de f marBupropion (GSK) Depresión Dejar de fumarMinoxidilo (J&J) Hipertensión (oral) Alopecia (cutáneo)Duloxtina (Cymbalta) Depresión / DPNP Incontinencia Urinaria( y ) pRopinirole (Requip; GSK) Parkinson Síndr. Piernas cansadasPaclitaxel Anticanceroso + Drug Eluting Stent para
d ió t ireducción re-estenosis
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Proyectos actualmente en desarrollo
Product Repositioning Strategy for Success.Product Repositioning Strategy for Success.
Proyectos actualmente en desarrollo.
M di t A t O i i l N tMedicamento Area terap. Original Nueva area terap.Estatinas (Inh. HMG-CoA reductasa)
Hipolipemiantes Alzheimer
Agonistas PPAR-γ Hipoglucemiantes AlzheimerTamoxifeno Anticáncer Trastorno bipolar
(G )Imatinib (Gleevec;Novartis) Anticáncer Artritis reumatoideAnticonvulsivantes Antiepilépticos Trastorno bipolar
Estabilizadores del ánimoEstabilizadores del ánimo