biotechnology and health care: portuguese … · 2009.12.02 biotechnology and health care:...

BIOTECHNOLOGY AND HEALTH CARE:PORTUGUESE SOLUTIONS FOR LIFE

INNOVATION AND INTERNATIONALIZATION

’s case

Luís Portela

London2009.12.02

2009.12.02

Biotechnology and Health Care: Portuguese Solutions for Life

INNOVATION AND INTERNATIONALIZATION – BIAL’s case

2

Source: The Pharmaceutical Industry in Figures, 2009 edition, EFPIA.

R&D investment as percentage of sales, 2007

Electronics

Automobile

Aeroespace

Leisure

Health Eq. & Serv.

Informatic Equip.

Software

Pharmaceutical

0 2 4 6 8 10 12 14 16 18

2009.12.02



3

S cre

enin

g ( 1

0 .00

0 m

o le c

u les

)

1 medicinal product

10 years of R&D 2 to 3 years ofadministrative procedures

0 5 years 10 years 15 years 20 years 25 yearspatent expiry SPC

maximum + 5 years

Patent

appli

cat

Phases of the R&D process for a medicinal product

Source: AGIM,Recherche et Vie.

ion

Acute

toxicit

y

Pharm

acolo

gy

Chronic

toxic

ity

Phase

I

Phase

II

Phase

III

Regist

ration

(MA)

PriceReim

burse

ment

Pharm

acov

igilan

ce

Clinica

l trial

s

2009.12.02



4

0.000

5.000

10.000

15.000

20.000

25.000

30.000

35.000

40.000

1980 1985 1990 1995 2000 2005 2008e

€ million

Source: Charles River Associates, 2004 (until 2000) and EFPIA (since 2005).

Pharmaceutical R&D expenditure

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5

Source: SCRIP Annual Review, 1991-2003 and IMS.

New active substances introduced in the market, 1990-2009p

Country Nº Products Companies (present)United Kingdom 69 GSK, AstraZeneca, Shire, Encysive

Germany 45 Bayer-Schering, Boehringer, Merck-SeronoFrance 29 Sanofi-Aventis, Servier, Ipsen, BiocodexItaly 15 Menarini, Sigma Tau, Recordati, ChiesiSpain 14 Almirall, Esteve, Faes, Ferrer, Uriach, Zeltia, SalvatDenmark 12 Novo Nordisk, Nycomed, LundbeckBelgium 6 UCB, SolvayIreland 5 ElanFinland 3 OrionAustria 1 Latvia 1 Institute of Microbiology and UrologyPortugal 1 Bial

TOTAL EU 201 31 USA 287 Pfizer, J&J, MSD, Abbott, Wyeth, BMS, Lilly, Amgen, Schering-Plough, Enzyme, Allergen, Forest, Biogenic,

Gilead, Barr, Alcon, Watson, Sepracor, Milan, Colene, Amyl in Pharma, MAGI Pharma, United Therapeutics, Bio Marin, NPS Pharma, Inched, Alexon, Terceira

Japan 150 Takeda, Daiichi-Sankyo, Astellas, Eisai, Shionogi, Otsuka, Tanabe, Kyowa, Ono, Dainippon-Sumitomo, Mitsubishi, Kayaku, Shinyaku, Meiji Seika

Switzerland 56 Roche, Novartis, ActelionOthers 22 Tea (Israel), CAL (Australia), Douglas (New Zealand), Burkwang (South Korea), Allofarm (Russia),

Dong A (South Korea)

TOTAL 716 82

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BIAL Facilities - Portugal

2009.12.02



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PortugalTop 10 Pharmaceutical Companies

2009.12.02



8

BIAL in the WorldBIAL is active in about 40 locations in 4 continents.

2009.12.02



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Searching for new therapeutic solutions

• Neurological diseases• Cardiovascular diseases• Allergic diseases

Porto

Bilbao

R&DBIAL’s mission

2009.12.02



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R&DBIAL’s structure

• 100 people (24 Ph.D) / 7 nationalities

• Contracts with 86 R&D institutions (1993-2009)

• > € 40.000.000 / year

• > 10.000 new molecules (1993-2009)

• 6 new medicines

2009.12.02



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Antiepileptic Eslicarbazepine Acetate – Zebinix®

Development timeline

2009.12.02



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• SEPRACOR - Canada- USA

• EISAI - Austria - Hungary - Norway- Belgium - Iceland - Poland- Bulgaria - Ireland - Romania- Czech Republic - Italy - Russia- Denmark - Latvia - Slovakia- Estonia - Liechtenstein - Slovenia- Finland - Lithuania - Sweden- France - Luxembourg - Switzerland- Germany - Monaco - United Kingdom- Greece - Netherlands - Turkey

note: in red the countries where the product is already being commercialized.

Licenses for the Commercialization of ZEBINIX®

2009.12.02



13

BIAL Pipeline

BIOTECHNOLOGY AND HEALTH CARE:PORTUGUESE SOLUTIONS FOR LIFE

INNOVATION AND INTERNATIONALIZATION

’s case

London2009.12.02

[email protected]

www.bial.com

biotechnology and health care: portuguese … · 2009.12.02 biotechnology and health care:...

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