HEMOBRAS PROJECT

Luiz Amorim, M.D.

Director of Production and Innovation

JULY 2012

BRAZIL

North

7.60% North-East

28.12%

Center-West

6.85%

South-East 45.62%

• Brazilian Population:

195,000 million

• GDP: 2.09 U$ trillion

• 7th largest economy in the world

• Per Capita

income:

11,769 U$

South 14.8%

BRAZILIAN PUBLIC HEALTH

Unified Health System (SUS)

Universal Access

Free of direct charges

Open to all the Brazilian population

Covers near 70% of Brazilian population

BRAZILIAN CONSTITUTION - 1988

ARTICLE 199 - § 4º

“(...) It is forbidden to sell blood, blood components and plasma

derivatives”

Blood donation is non-remunerated, altruistic and anonymous

30% remaining covered by private health assurances

WHAT ABOUT PLASMA DERIVATIVES?

BRAZILIAN OPTIONS

YEAR 2000: TO FRACTIONATE

OR NOT TO FRACTIONATE?

OPTIONS IF THE ANSWER IS NOT TO FRACTIONATE

• IMPORT 100% OF THE COUNTRY NEEDS

• TOLL FRACTIONATION CONTRACT

• COMBINATION OF THESE TWO OPTIONS

OPTION 1: IMPORTATION ONLY

• Utilization of safe and proved medicines

• Avoid the risks of building and operate a fractionation plant

• Shortages: the worldwide demand can surpass the production

• Affordability : prices can get higher and difficult to afford

• Changes on the worldwide market: Consumption in countries with large populations can increase leading to a disequilibrium between supply and demand

ADVANTAGES RISKS

TOLL FRACTIONATION

• Proved system

• Allows the use of recovered plasma

• Complements and ensures the country supply

• Lower prices, compared to imports

• Free capacity of existing plants

• Contracts not easy to manage

ADVANTAGES RISKS

TO FRACTIONATE

• Technology incorporation

• Improve the country blood system

• Fast pay back

• Avoid plasma wastage

• Lowest cost

• High investment required

• Failure on the tech transfer

• Plasma availability

• Lack of specialized engineering teams

ADVANTAGES

RISKS

BRAZILIAN DECISION

• Toll fractionation

+

• Building a local plant - HEMOBRAS

+

• Import the remaining amount needed to

satisfy country’s demand

HEMOBRAS

• State-owned company, created for fractionating plasma and for producing plasma derivatives

• Started in 2006

• Not-for-profit organization

• Plant capacity: 500,000 liters of plasma/year

HEMOBRAS

• October 2007: LFB selected for transfer

of technology

• Concept and basic design started in

January 2008

• Albumin

• Factor VIII

• Factor IX

• IVIg

• Prothrombin Complex

• von Willebrand factor

HEMOBRÁS – PLASMA DERIVATIVES TO BE PRODUCED

TOLL FRACTIONATION IN BRAZIL: PART II

• 2007: New tender for select one company for toll

fractionation

• LFB wins the tender

• April 2010: Hemobras assumes the contract

• Toll fractionation activities coupled to the tech transfer

activities

HEMOBRAS LOCATION

CITY OF RECIFE

• LAND SURFACE: 250,000 m2

• BUILT AREA: 48,000 m2

HEMOBRAS LAND

HEMOBRAS LAND

TOTAL SURFACE: 250,000 m2

HEMOBRAS PLANT: ELECTRONIC MAQUETTE

BUILT SURFACE: 48,000 m2

HEMOBRAS COLD CHAMBER BUILDING

HEMOBRAS COLD CHAMBER BUILDING

HEMOBRAS AUTOMATIC COLD CHAMBER - OPERATED BY TRANSELEVATORS

HEMOBRAS AUTOMATIC COLD CHAMBER - OPERATED BY TRANSELEVATORS

CONVEYORS FOR PLASMA TRANSPORTATION INTO THE COLD CHAMBER

PLATFORMS FOR PLASMA INSPECTION

HEMOBRAS: GENERAL VIEW

HEMOBRAS WAREHOUSE

HEMOBRAS: ASEPTIC FILLING AND FRACTIONATION BUILDINGS

HEMOBRAS: QUALITY CONTROL BUILDING

HEMOBRAS: PACKAGING BUILDING