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INVESTMENT OPPORTUNITIES




Biotechnology in Argentina
Knowledge + Innovation to meet global market needs
Photo: courtesy of INTI. National Institute of Industrial Technology
Highlights
 FACING A GLOBAL OPPORTUNITY
   The global biotechnology market has been growing at a strong rate, driven
   by constant technological and scientific advances and broadening areas
   of application. Mainly concentrated in the U.S., the biotechnology industry
   presents attractive opportunities for those countries with the right set of
   resources.

 REMARKABLE DOMESTIC POTENTIAL
   Growing private and public RD activities, a pool of highly qualified human
   resources in biosciences, and developed pharmaceutical and food  beverage
   industries put Argentina in a strong position to take advantage of growth in the
   global biotechnology market.

 PROMISING PERFORMANCE AND A WIDENING SCOPE
   As one of the regional leaders in the biotechnology industry, Argentina’s
   domestic sales and exports have grown significantly. Mainly focused on
   agricultural applications, local firms are currently making progress throughout
   all biotechnology application areas.

 MEETING GLOBAL DEMANDS
   By continuing to embrace biotechnology and its applications, Argentina will
   be able to meet an increasingly global and sophisticated demand for food and
   health products while protecting the environment for future generations.

 CHALLENGES AHEAD
   The main challenges for the growing local biotech market include furthering
   the integration of biotechnology with the overall economy; keeping up with the
   increasing demand for qualified human resources; increasing RD capacity; and
   improving public  private sector coordination.




May 009
I. Why Invest in Biotechnology in Argentina?
    Photo: courtesy of Bio Sidus labs




    • HUGE POTENTIAL. Biotechnology consists in the                                • COMPETITIVE RESOURCES. The combination of
                        application of science and technology to living             growing private and public RD activities, a pool
                        organisms, biological systems, or derivatives thereof,      of highly qualified human resources in biosciences,
                        to make or modify products or processes for the             and well-developed pharmaceutical and food and
                        production of knowledge, goods and services. Modern         beverage industries put Argentina in a privileged
                        biotechnology can substantially contribute to improve       position to capitalize on existing global opportunities.
                        human welfare and current living conditions by              In particular, the large number of researchers (highest
                        delivering essential outputs as pharmaceutical products     per active person in Latin America), over 35 biosciences
                        or vaccines and increasing both the quantity and quality    research institutes within firms and universities,
                        of food.                                                    doctoral and postdoctoral biotechnology training
                                                                                    institutions, and a leading position in genetically
    • A THRIVING GLOBAL INDUSTRY. The global                                        modified crop use, provide Argentina with strong
                        biotechnology industry has been growing steadily,           foundations to build a dynamic and sophisticated
                        at a compound annual growth rate of 13% during              biotechnology industry.
                        2000-2007. Despite worldwide economic turmoil,
                        the industry sustained its solid performance in 2008,      • PROFITABLE AREAS OF APPLICATION. Modern
                        growing 12% in revenues to US$89.7 billion. While the       biotechnology has applications in many fields, including
                        U.S. accounts for over half of global revenues, other       human and animal health, agriculture, fishing and
                        countries are exhibiting significant growth rates.          forestry, food processing, industrial processing, and
                        Argentina is among those countries.                         natural resource extraction. At the global level, the
                                                                                    health sector is the largest, representing almost
    • REGIONAL LEADERSHIP. Knowledge being the key                                  two thirds of total revenues. The agriculture  food
                        component in the biotech industry, Argentina managed        processing segments account for approximately
                        to leverage its strong research capacity to host and        12%. Argentina has already established competitive
                        create companies that use or produce biotechnology          advantages in some niches within the industry,
                        inputs. With over 80 established companies, Argentina       particularly in agricultural, food and health segments.
                        is the country with the highest amount of biotechnology     The local market is especially focused on the production
                        companies per capita in Latin America. Domestic             of agricultural inputs, pharmaceutical products, human
                        firms feature a wide range of activities, from the use      diagnosis products and fine chemicals (amoniacids,
                        of biotechnological supplies in production processes        pigments, antibiotics and vitamins).
                        to the manufacture of modern biotechnology products
                        through recombinant DNA techniques.
II. Industry Structure and Performance
STRUCTURE                                                                                                       INDUSTRY SEGMENTS
Diverse and competitive sector. More than 80                                                                    A diverse array of products are being produced locally,
firms produce modern biotechnological products locally,                                                         covering several areas of biotechnology applications.
covering a wide range of activities: 29% of firms produce                                                       Agriculture, food processing, human heath and diagnosis,
inoculants, 23% seeds and plant varieties, 12% animal                                                           and animal health are segments in which domestic
health products, 12% food ingredients and 24% human                                                             biotechnology presents attractive competitive advantages.
health products. The sector is composed of a mix of global
players and growing domestic companies. Global leaders                                                          Agricultural sector. Within agriculture, biotechnology
such as Bayer CropScience, Dow AgroSciences, Nidera,                                                            has many applications, including genetic modifications
Monsanto and Pioneer are active in the country, and                                                             (GM) of plant varieties, seeds, inoculants, pesticides,
local firms like Bioceres, Biocientífica, Biogénesis-Bagó,                                                      fertilizers, vet products and genetic selection for cattle
BioSidus, Cassará, Indear and Wiener Lab are competitive                                                        breeding. The worldwide performance of GM crops stands
players in diverse segments. Around 80% of firms are                                                            out, increasing its market size 65-fold in 1996-2008 to
domestic small and medium size companies, focused                                                               US$7.5 billion. GM crops currently cover an area of 125
almost exclusively on biotechnological activities.                                                              million hectares in 25 countries in six continents. These
                                                                                                                figures are expected to double in the next ten years.
INDUSTRY BUSINESS PERFORMANCE
Sales and exports. Conservative estimations calculate                                                                                                                              GM Crop Area by Country

biotechnology annual sales at US$400 million and                                                                                                                               China 3% Others 5%
employment in the sector at more than 5,000 workers. The                                                                                                        India 6%

                                                                                                                                                 Canada 6%
agricultural sector leads the sales by area of application:
seeds and plant varieties concentrate 41% of total sales,                                                                                     Brazil 13%                                                                                                                 U.S. 50%
animal health explains 25%, and inoculants add an
additional 8%. The food ingredients sector accounts for
                                                                                                                                                                    Argentina 17%
15% of sales and human health for the remaining 11%.
Biotechnology exports amount to over US$80 million                                                                                            Source: International Service for the Acquisition of Agri-biotech Applications (ISAAA)



(60% in agro related activities and 24% in human health),                                                            Endowed with vast extensions of arable land (32 million
resulting in a biotech trade surplus of over US$50 million.                                                     hectares), Argentina embraced, at an early stage, the use
Seeds and plants and human health explain together 72%                                                          and generation of genetically modified crops, leading to
of total employment, distributed in almost identical shares.                                                    an agricultural revolution that increased both the size of
Private RD explains over 5% of sales, reaching some                                                            the cultivated land and the yields per hectare of its main
US$20 million in total, with the highest ratio seen in human                                                    crops. Record-high levels of agricultural production
health (15%). The number of patents presented to the U.S.                                                       are reached year after year. Argentina is today a leading
Patent and Trademark Office (USPTO) ant the European                                                            country in adopting biotech crops: it has the highest
Patent Office (EPO) by the Argentine biotech sector                                                             percentage of arable land planted with GM crops (65%),
amounts to 53 and 12 per year in 2001-2007 respectively.                                                        it is the second largest producer of GM crops (21 million

                          Biotechnology by Segment
              Share of total firms, sales, employment and exports                                                                                      Soybean Area and GM Soybean Evolution
100%
                                                     11                                                                                    20.000                                                                                                                                 10 0
                                                                                                                                                                                                                                                                              90
                                                                             6                                                            18.000
                                                                                                                In thousand of hectares




 80%                                                 1
                                                                                                                                           16.000                                                                                                                                 80
                       1                                                                         1
                                                                                                                                           14.000                                                                                                                                 70
 60%                   1                                                  11
                                                                                                                                           12.000                                                                                                                                 60
                                                                             10                   0                                       10.000                                                                                                                                 50 %
 0%                   
                                                                                                                                            8.000                                                                                                                                 40
                                                     1                      6                                                             6.000                                                                                                                                 30
 0%                                                                                              
                       0                                                                                                                   4.000                                                                                                                                 20
                                                      8                       8                   4                                         2.000                                                                                                                                 10
  0%
                                                                                                                                              -                                                                                                                                   -
                     Firms                         Sales                  Employment            Exports
                                                                                                                                                                                                                 3


                                                                                                                                                                                                                           4


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                                                                                                                                                                                   0


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                                                                                                                                                  96


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                                                                                                                                                                               99




                                                                                                                                                                                                   01




       Inoculants            Seeds  Plants               Animal Health      Food Ingredients    Human Health
                                                                                                                                                                                                            20


                                                                                                                                                                                                                      20


                                                                                                                                                                                                                                20


                                                                                                                                                                                                                                          20


                                                                                                                                                                                                                                                    20


                                                                                                                                                                                                                                                              20


                                                                                                                                                                                                                                                                        20
                                                                                                                                                                                        20


                                                                                                                                                                                                  20
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                                                                                                                                                          19


                                                                                                                                                                    19


                                                                                                                                                                              19




                           .
Source: Bisang, Gutman, Lavarello, Sztulwark and Diaz (006)                                                                              Source: CONABIA and SAGPYA                               Total soybean area                                GM soybean/ Total soybean
hectares; 17% of world GM area) and enjoys top-notch                                  DNA technology, including human erythropoietin, human
    productivity in soy, corn and their derivatives. Some                                 interferons, colony-stimulating factors and human growth
    companies also produce bioinsecticides and pulse crop                                 hormone. These products are already sold in Asia, the
    inoculants, while others use seedling micropropagation                                Middle East and Latin America. Argentina is, along
    and vegetable tissue culturing technologies.                                          with the U.S., Australia, Korea and New Zealand, one of
                                                                                          the few countries in the world with the technology of
    Food Processing. Argentina counts with a large and                                    pharmaceutical diary. It is also one of nine countries with
    highly competitive food and beverage industry, with                                   capacity to clone animals successfully. BioSidus is one
    total sales of US$53 billion (31% of total manufacturing                              of the sector’s leaders. In the field of diagnosis, there are
    production sales) and exports of US$21 billion (30% of                                products and developments using recombinant protein
    total manufacturing production exports). Significant                                  and monoclonal antibodies to detect infectious diseases,
    applications of biotechnology are being developed                                     such as Chagas’ Disease, Cholera, Hepatitis B and C,
    and implemented in this field. Biotechnology in food                                  and HIV. There is also capacity for molecular oncology,
    processing is focused on the production of high-fructose                              leukocyte differentiation antigens, genetic predisposition to
    corn syrup and its intermediate product glucose syrup.                                hereditary diseases, and filiations and personal identity.
    Five companies stand out in this segment. While three
    of them are domestically-owned (Alimentaria San Luis,                                                    Sales of Domestic Pharmaceutical Production
    Arcor and Georgalos), the other two have been acquired by                                                              (in US$ million)
                                                                                          2.500
                                                                                                               Exports
    global food companies (Industrias de Maíz and Refinerías
                                                                                                                Internal market
                                                                                          2.000
    de Maíz). Two leaders in the dairy sector (SanCor and
                                                                                          1.500
    La Serenísima-Danone) have recently launched their
    probiotic milk lines by incorporating Lactobacillus and                               1.000


    Bifidobacterium strains that, as probiotic species, favor the                          500


    intestinal microbacterial ecosystem.                                                    0
                                                                                                          2002             2003              2004               2005   2006   2007   2008
                                                                                                  Source: National Institute of Statistics and Census (INDEC)



                       Food  Beverages: Production and Exports
                                   (in US$ million)
    60.000
                    Production                                                            Animal health. The strong local pharmaceutical
                    Exports
    50.000
                                                                                          tradition and the knowledge generation in related areas
    40.000
                                                                                          allowed for the production of transgenic cattle and animal
    30.000
                                                                                          vaccines. Important progress was made in the areas of
    20.000
                                                                                          animal food and health due to the active involvement
    10.000

       -
                                                                                          of national and multinational companies present in
                  2002            2003            2004        2005   2006   2007   2008
                                                                                          Argentina. A salient case in the area of animal vaccines
             Source: Center of Studies for Production (CEP)

                                                                                          is the production of the vaccine against bovine neonatal
                                                                                          diarrhea caused by rotavirus. This vaccine was the result
    Human Health and Diagnosis. Applied biotechnology’s                                   of a joint project between the Center for Animal Virology
    greatest impact in terms of industry has occurred in                                  (CEVAN) and the National Council for Scientific and
    pharmaceuticals, where a long-standing tradition of                                   Technical Research (CONICET). Other examples of public-
    biomedicine combines with a large domestic industry.                                  private collaboration include the vaccines developed by
    With local pharmaceutical production growing at an                                    the Virology Lab of the National Institute for Agricultural
    annual rate of 16% between 2002 and 2008, investments                                 Technology (INTA) that were produced and marketed
    have increased 10 times during this period. Pharmaceutical                            by Biogénesis and San Jorge-Bagó labs. This sector also
    domestic companies have the capacity to develop new                                   produces and markets vaccines against foot-and-mouth
    products covering all stages from product innovation                                  disease and exports vaccines for salmons. Vilmax, a leading
    through commercialization, including pilot plant tests,                               company in the production of colorants, manufactures
    manufacturing, clinical trials and regulatory authority                               specific colorants to purify proteins.
    approval. Most products result from applying Recombinant

6
CASE STUDY
Bio Sidus: translating scientific breakthroughs into products for a better quality of life

BioSidus, under the guidance of the pharmaceutical          to ensure the perpetuity of the transgenic lineage.
firm Sidus, has become a leading organization in            Human growth hormone obtained from the milk
the biotechnological field, thanks to the efficient         of these transgenic cows has already been tested
integration of both enterprise and technology.              for bioequivalence against the bacterial-derived
By the end of the 190s, the managing staff of              reference product and is about to start efficiency
“Instituto Sidus”, conscious of the central role            clinical trials. The production of recombinant human
of modern biotechnologies, decided to enter                 proteins in the milk of transgenic cows is expected
in the biotechnological research field. In 1980,            to be a highly efficient and cost-effective method
Sidus’ Area of Biotechnology was created,                   compared to more traditional manufacturing
under Sidus’ entrepreneurial support and the                techniques, with the yield from only a small number
scientific concurrence of an important group of             of transgenic cows meeting market demand for
professionals from the University of Buenos Aires.          many medical applications. Additionally, BioSidus has
The goals successfully achieved in technological            developed lineages of transgenic cows to produce
and manufacturing developments led Sidus in                 bovine growth hormone for veterinary use. However,
198 to create BioSidus as an organically individual        the most ambitious target in this technological
enterprise, which by 1990 had rolled out its first          platform is the development of transgenic cattle for
biogeneric product: erythropoietin. Almost 0 years         human insulin precursor. To this day, eight cloned
later, BioSidus commercializes locally and abroad           transgenic cows were born which will be induced to
seven recombinant proteins for use in human health:         lactation in the coming months to assess presence
erythropoietin, interferon alfa a and b, interferon       of human insulin precursor in their milk. As from this
beta 1a, filgrastim, lenograstim and somatropin.            milk, the human insulin precursor will be purified to
Additionally, BioSidus counts with a pipeline of            homogeneity and submitted to an enzymatic cleavage
multiple biosimilar candidates in different stages of       to recover biopharmaceutical degree human insulin.
development. Lead products in the pipeline include          This will be of special significance because it will allow
PTH 1-, interferon beta 1b and streptokinase.             large quantities of product at an affordable cost to
                                                            meet the increasing demand of insulin to treat the
Over % of BioSidus revenues come from exports             growing population of diabetes patients.
to almost 0 countries in Latin America, Middle East,
Eastern Europe and Asia Pacific (including India,           Ongoing projects also include gene therapy targeting
Thailand and Lebanon) holding a significant market          angiogenesis of ischemic heart tissue. BioSidus has
share in these territories. Furthermore, the company is     developed and produced pharmaceutical grade
filing for regulatory approval to distribute its products   naked plasmid DNA codifying for the human protein
in 10 additional countries through partnerships with        vascular endothelial growth factor and has assessed
local pharmaceutical firms. Its recently launched           through preclinical testing in laboratory animals
product, Interferon beta 1a, is rapidly gaining market      that its injection into the cardiac muscle resulted in
presence in different countries.                            increased growth of new blood vessels as well as in
                                                            muscle regeneration. These findings led to conduction
In addition, the company is taking steps to prepare         of Phase I clinical studies currently underway with
for its eventual commercialization in developed             promising results. Phase II clinical trials are set to start
countries. To achieve this goal, BioSidus is in the         in 009.
process of upgrading its manufacturing processes
and refurbishing a new facility in line with U.S. FDA       In collaboration with the Argentine Dirección Nacional
and EMEA regulatory standards. To accomplish this,          del Antártico, research has been conducted aimed
BioSidus has entered into a strategic association with      at the isolation and characterization of certain
an U.S. based firm to distribute its current product        microorganisms from the Antarctic territory that
portfolio in the U.S..                                      are particularly adapted to extreme temperature.
                                                            A novel species has been isolated and identified
With significant investments in RD, BioSidus activities    - Bizionia argentinensis, and its full genome has been
include the development of expression systems to            sequenced. In this sense, BioSidus is once again a
produce, formulate and clinically test recombinant          pioneer in genomics in Argentina since this is the
proteins for human health. The company’s RD efforts        first national experience of integral sequencing of
focused on innovative transgenic biopharmaceutical          a microorganism genome. The genome is currently
manufacturing merit special mention. BioSidus has           under analysis seeking for genes that encode for
built up a pharmaceutical dairy comprised of a herd         enzymes active at cold temperature. There is a great
of  cloned transgenic cattle, including twelve cows       potential for industrial applications of these “cold
producing biopharmaceutical grade recombinant               enzymes” in the food, textile and laundry industries,
human growth hormone in their milk and seven bulls          among others.
III. Foundation for Success

    LOCAL SKILLS AND TALENT                                      financed courses for more than 2,400 students from
    Qualified human resources. Developing                        Argentina, Brazil, Uruguay and Paraguay
    biotechnology requires highly qualified human resources.
    Argentina is the country with the highest number of
    researchers per active person in Latin America (3.4/1,000    RESEARCH AND DEVELOPMENT
    active) and has internationally renowned scientific          Research institutes. Research institutes from
    skills and a pioneering spirit. In natural sciences, this    universities and companies carry out RD activities in
    tradition is evidenced by three Nobel Prizes awardees (B.    a wide range of disciplines and specialties in Argentina.
    Houssay, L. Leloir and C. Milstein). In total, over 59.000   Almost 70 of these centers (41 companies and 27 research
    researchers and scholars undertake research activities       groups) are focused on agricultural issues and 37 are
    both in the public and private sectors. These talents are    dedicated to biosciences. Specifically, 28 are devoted
    also growing thanks to the Program RAICES, a strategic       to biotechnology research, including public centers,
    project from the Ministry of Science and Technology          university centers and private foundations.
    that promotes and facilitates the return of Argentine
    distinguished researchers working abroad. In the last few    Regional hubs and business incubators. A recent
    years more than 600 professionals have been relocated in     trend has been the emergence and consolidation
    local research institutions.                                 of technological hubs and business incubators in
                                                                 different knowledge-intensive fields. A highlight within
    Specialized research and training. Today, 1,350              agricultural research is the Rosario biotechnological
    researchers and technicians undertake scientific             hub in the province of Santa Fe. Comprised of several
    research in biosciences. Specifically, 241 scientists and    institutions mainly devoted to vegetal biotechnology,
    101 technicians are involved in biotechnological research    the hub brings together more than 400 professionals,
    lines. More than 30 universities and higher education        constituting the main biotechnological pole in Latin
    institutions offer undergraduate and graduate careers        America. The Argentine-Spanish Center for Plant
    in biotechnology. Scientific researchers continue their      Genomics (CEBIGEVE) and the National Institute for
    education through doctoral and postdoctoral scholarships     Agro-biotechnology (INDEAR) are two of its members.
    sponsored by CONICET. Additionally, courses for              CEBIGEVE is an RD center resulting from the scientific
    researchers coming from the public and private               cooperation between Spain and Argentina. INDEAR, in
    sector are offered at the Argentine-Brazilian School of      turn, results from the partnership between the private
    Biotechnology (EABBIO). From 1987 to 2003, EABBIO            firms Bioceres and BioSidus and the CONICET.
                                                                                                                             Photo: courtesy of Biogénsesis Bagó




8
Photo: courtesy of Roemmers labs




COMMUNITY                                                                                                                                                         INDUSTRY NETWORKING
Public perception. Argentina has a positive public                                                                                                                There are several organizations that promote
perception of biotech products and a good acceptance                                                                                                              biotechnology and communicate the sector´s news
of transgenic organisms. The first genetically-modified                                                                                                           and achievements in Argentina:
crop in Argentina’s agriculture was glyphosate-tolerant
soybean, approved in 1996. Since then, several crops                                                                                                              • FAB (Argentine Forum on Biotechnology):
and their features have been tested in the field, and                                                                                                              with 20 years of continuous experience, the
this type of technology has spread rapidly. In the last                                                                                                            organization promotes biotechnology and
agricultural campaign, they accounted for over 90% of                                                                                                              cooperation and collaboration among researchers,
soybean planted area, around 70% of corn planted area,                                                                                                             companies and the government to fully develop
and approximately 60% of the cotton planted area. At the                                                                                                           biotechnology.
government level, Argentina supports biotechnological
undertakings, leveraging communication and information,                                                                                                           • BIOTECSUR: a biotechnology platform that
and improving controls to provide security to consumers.                                                                                                           brings together the private, academic and public
                                                                                                                                                                   sectors from the four countries of MERCOSUR
                                                                                                                                                                   and works to establish a common long-term
                                                                                                                                                                   vision for the development and application of new
                                                                        Sowed Area by Type of Crop                                                                 technologies in the region.
                                                                         (in thousands of hectares)

                                                                                                                                                                  • ASA (Argentine Association of Seed Traders):
30,000                                                             GMO’s
                                                                   Conventional                                                                                    it has a proactive attitude to spread biotechnology
25,000

20,000
                                                                                                                                                                   through the “Por qué Biotecnología” (Why
15,000
                                                                                                                                                                   Biotechnology?) program.
10,000

 5,000                                                                                                                                                            • RedBio (reporting to Food and Agriculture
                                      -                                                                                                                            Organization): responsible for a communication
                                                                                                           3


                                                                                                                     4


                                                                                                                               5


                                                                                                                                         6


                                                                                                                                                   7


                                                                                                                                                             8
                                               7


                                                         8


                                                                    9


                                                                             0


                                                                                       1


                                                                                                 2




                                                                                                                                                                   campaign at primary, secondary and tertiary
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                                                                                   00




                                                                                                       02


                                                                                                                 03


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                                                                                                                                               06


                                                                                                                                                         07
                                           96


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                                                               98


                                                                         99




                                                                                             01
                                                                                  20


                                                                                            20


                                                                                                      20


                                                                                                                20


                                                                                                                          20


                                                                                                                                    20


                                                                                                                                              20


                                                                                                                                                        20
                                          19


                                                    19


                                                              19


                                                                        19




                                    Source: Argentine Association of Seed Traders (ASA) and Secretariat of Agriculture, Livestock, fishing and Food (SAGPYA).       educational levels.

                                                                                                                                                                                                                         9
IV. Policy Initiatives
     Photo: courtesy of INTI. National Institute of Industrial Technology




     BUSINESS PROMOTION                                                     investment, and biotechnology has always been a priority
     Incentives. Government, private companies and                          topic during the last decades. These tools have been
     research institutions are working together in the                      deepened since the creation in 2007 of the Ministry
     promotion of modern biotechnology. Law 26,270                          of Science and Technology. Within the Ministry, the
     sets promotional measures that are related to human                    National Agency for Scientific and Technological
     resources and capital expenditures during RD and                      Promotion (ANPCyT) encourages scientific, technological
     production of technologies applicable to several                       and innovation-related activities with resources coming
     productive areas. The law’s main benefits, which are in                from contributions from the national budget and the
     process of being regulated by the technical authorities,               Inter-American Development Bank (IDB). The two
     include accelerated amortization of the income tax,                    main Agency funds are the Fund for Scientific and
     early reimbursement of Value Added Tax, and tax credit                 Technological Research (FONCyT) and the Argentine
     bonds for contributions to the social security and services            Technology Fund (FONTAR).
     purchased from government-owned research institutes.
     It also establishes the development of a special fund for
     new undertakings. Innovation resulting from the benefits
     of the scheme shall be, in the first place, patented by the              National Agency for Scientific and
     relevant domestic patent offices.                                        Technological Promotion (ANPCyT)

     Venture capital. Government is increasingly involved                     Fund for Scientific and Technological Research
                                                                              (FONCYT): Supports research projects targeted
     in the promotion and development of venture capital                      at generating new scientific and technological
     funds for technology-based companies in Argentina.                       knowledge. Promotion and financing instruments are
     The Ministry of Science and Technology has put in place                  awarded, in all cases, through public bids. The FONCyT
                                                                              has sponsored an important number of projects in the
     the Program CREARCIT to encourage the growth and
                                                                              area of biotechnology between 00 and 008, for
     creation of innovative firms in all technological fields                 over US$ million.
     through venture capital investment.
                                                                              Argentine Technology Fund (FONTAR): Supports
                                                                              projects targeted at improving the private sector
                                                                              productivity on the basis of technological innovation.
     SCIENTIFIC PROMOTION                                                     There are various financing instruments granted
     Funds for RD. The national government has                               through public bids or permanent window. The
     implemented several programs and instruments that                        FONTAR has approved biotechnological projects for
                                                                              over US$1 million in 00-006.
     promote and facilitate basic research and technological

10
REGULATORY FRAMEWORK                                         Promoting and protecting health. The National
Environmental and health safety. In Argentina,               Administration of Drugs, Foods and Medical Technology
GMOs are evaluated before these products are marketed.       (ANMAT) promotes and protects human health by
Since 1992, 400 field trials for different transformation    assuring the quality and efficacy of medical products,
events have been assessed and authorized. The                food and domestic-use products, medical and diagnosis
evaluation process includes three steps. First, the          devices. Since 1992, the Ministry of Health is in charge of
National Advisory Committee for Agricultural                 providing authorization for release to the market.
Biotechnology (CONABIA) evaluates the likely impact
on the agricultural ecosystem, comparing potential           Intellectual Property Rights. As a signatory of the
environmental consequences with those of conventional        Trade-Related Aspects of Intellectual Property Rights
plants, initially through experimental release and then      agreement (TRIPS), Argentina provides an effective
more extensive release into the environment. Second,         patent protection system, including pharmaceutical
the National Service of Agricultural and Food Health         products. The National Institute of Industrial Property
and Quality (SENASA) conducts a food safety evaluation.      (INPI) made significant progress in reducing its patent
Third, the National Direction for Agricultural Food          backlog, including the implementation of fast-track
Markets (DNMA) makes an evaluation of potential              procedures and a one-time opportunity in 2005 for
commercial impact by analyzing the status of the GM          companies to prioritize their patent applications before
product under study in the destination markets in terms      INPI. FONTAR offers subsidies to SMEs to apply for
of whether the product has been approved or not and, as      patents both locally and abroad.
a result, whether the addition of a GM crop to Argentina’s
exports might represent a potential barrier to access
these markets. To date, 10 GM crop varieties have been
authorized for sale.




                                                                                                                                Photo: courtesy of Biogénsesis Bagó




                                                                                                                           11
V. Main Challenges



            Industry players and government agencies face key
            challenges to sustain growth and consolidate the sector’s
            competitiveness. In themselves, these challenges present
            attractive opportunities for the industry and Argentina.


            • Increase the availability of qualified human
             resources: an increasing domestic and international
             demand for Argentine biotech products will require
             expanding the current RD capacity in human resources
             and facilities on which Argentina sustains its competitive
             advantage.


            • Consolidate and expand its leadership in the use
             and development of GM crops: Argentina’s substantial
             use of GM crops presents a vast area of application for
             biotechnology, which must be consolidated as a driver for
             local industry growth.


            • Promote and foster the integration of
             biotechnology research centers with companies:
             the adequate institutional processes must be developed to
             further close the gap between research in biotechnology
             and its technology transfer to the demanding industries.


            • Establish efficient interaction mechanisms
             between the public and private sectors: achieving
             a balanced growth within the industry will require
             strengthening the strategic cooperation among firms and
             government agencies.


            • Develop and provide biotechnological solutions
             to regional economic activities: regional activities
             like wine and fruit production could surely benefit from
             the application of new biotechnologies.


            OUR CHALLENGES ARE YOUR OPPORTUNITIES.




1
Photo: courtesy of INTI. National Institute of Industrial Technology




SOURCES: The trends, data and figures included     on Global Status of Biotech/GM Crops, 008 /          The information provided through this brochure
in this material were elaborated by ProsperAr      Ministry of Science and Technology (MINCYT) /         does not in any way constitute legal or
based on information provided by: Argentine        National Institute of Statistics and Census (INDEC)   professional advice. ProsperAr (Agencia Nacional
Association of Seed Traders / Argentine Forum on   / National Observatory for Science Technology         de Desarrollo de Inversiones) reserves the right
Biotechnology (FAB) / BiotecSur / Bisang, Campi    and Innovation, Strategic Plan, 00 / OECD,          to revise, amend, alter or delete the information
and Cesa, “Biotecnología y desarrollo”, CEPAL,     Biotechnology Statistics, 006 / Sánchez,             provided herein at any time and in no way be
009 / Bisang, Gutman, Lavarello, Sztulwark and    Rozemberg, Butler and Rufo, “The emergence            held responsible or liable in respect of any such
Diaz (comp.) “Biotecnología y desarrollo. Un       of new successful export activities in Argentina:     revisions, amendments, alterations or deletions.
modelo para armar”, UNGS-Prometeo, Buenos          self-discovery, knowledge niches, or barriers to
Aires, 006 / Center of Studies for Production     riches?”, IDB, 008 / Secretariat of Agriculture,     Cover photo: courtesy of Roemmers labs.
(CEP) / Ernst  Young, Beyond Borders: Global      Livestock, fishing and Food (SAGPYA).
Biotechnology Report 009 / ISAAA Report

                                                                                                                                                             1
Argentina at a glance


     Country profile

     Official name                                                                   República Argentina

     Capital city                                                                    Buenos Aires

     Main cities                                                                     Córdoba, La Plata, Mar del Plata, Mendoza, Rosario

     Surface area                                                                    . million square kilometers

     Population                                                                      0.6 million inhabitants

     Population growth                                                               1.0% per year

     Adult literacy rate                                                             98%

     Life expectancy at birth                                                         years

     GDP per capita (PPP)                                                            US$ 1,1

     Currency                                                                        Argentine peso ($)

     Form of government                                                              Federal Presidential Republic

     Political division                                                               autonomous provinces and the Autonomous City of Buenos Aires

     Time zone                                                                       GMT-0:00

     Official language                                                               Spanish




     Main Economic Indicators
                                                                                                       00                 00                   00                  006                   00                      008
     GDP growth rate (annual %)                                                                         8.8%                9.0%                   9.%                   8.%                   8.%                     .0%
     GDP (PPP) (millions of US$)                                                                 ,99              ,01                19,68                69,0                ,10                ,860
     GDP (millions of US$)                                                                        18,08             1,18                181,96                1,868                60,68                8,0
     Exports of goods and services (millions of US$)                                                ,9              9,86                 ,0                 ,                 66,088                 8,608
     Imports of goods and services (millions of US$)                                                18,8              ,90                 ,99                 1,10                 ,                 6,9
     Balance of trade of goods and services (millions of US$)                                       1,61               11,9                1,08                 1,                 1,                  1,11
     Trade surplus (% of GDP)                                                                        1.%                   .8%                  6.6%                   6.%                   .9%                     .6%
     Current account surplus (% of GDP)                                                                 6.%                .1%                   .9%                   .6%                   .%                     .%
     Primary fiscal surplus (% of GDP)                                                                  .%                .9%                   .%                   .%                   .%                     .1%
     Gross capital formation (% of GDP, constant prices)                                             1.%                1.%                  19.8%                  1.6%                 .6%                  .0%
     Gross national savings (% of GDP, current prices)                                               19.6%                0.6%                 .%                  6.%                  6.6%                6.%E
     Foreign direct investment (millions of US$)                                                      1,6                ,1                  ,6                  ,                 6,                  ,99
     Exchange rate ($/US$)                                                                               .9                .9                   .9                   .0                   .1                    .16
     Foreign reserves (millions of US$)                                                             1,119              19,66                 8,0                 ,0                 6,16                 6,86
     Unemployment rate (% of EAP)                                                                     1.%               1.6%                  11.6%                  10.%                    8.%                     .9%

     Source: ProsperAr based on data provided by the Argentine National Institute of Statistics and Census, the Central Bank’s Market Expectations Survey (REM), the International Monetary Fund and the United Nations
     Conference on Trade and Development (as of April 0, 009).




1
ProsperAr is Argentina’s National Investment Development Agency
                 Our mission is to develop direct foreign and domestic investment to contribute
                 to Argentina’s competitiveness and sustainable development.

ProsperAr’s four main objectives are:
Provide services to investors
                 ProsperAr provides investors with personalized professional services throughout the investment
                 process, from initial advisory services to investment facilitation and aftercare. The Agency’s team
                 assesses on investment projects, responds to queries from investors and provides key business
                 information. Leveraging the Agency’s cooperative relationships with different government bodies,
                 ProsperAr’s integral services offer investors a unified one-stop support system.


Attract and generate investment
                 ProsperAr works in the promotion, attraction and expansion of both domestic and foreign investment.
                 We identify investment and innovation opportunities in high growth sectors, communicating
                 them to national and overseas investors through international missions, conferences, meetings and
                 publications. We work to build relationships that enable multinational companies to take advantage of
                 local, regional and global opportunities. We also encourage domestic firms to expand and develop their
                 businesses.


Boost the Investment Environment
                 ProsperAr works to strengthen Argentina’s investment environment. We interact with local and
                 multinational companies, as well as potential investors, identifying and removing possible obstacles to
                 doing business in Argentina. Through active dialogue with the private sector, and in coordination with
                 other government departments, we advocate for the formulation of policies and programs to optimize
                 the investment and innovation environment.


Promote the internationalization of local companies
                 ProsperAr promotes the growth and internationalization of Argentine firms. Fostering local vocation
                 for innovation and entrepreneurship and promoting overall competitiveness are key aspects of
                 the Agency’s strategy. Two programs “Entreprenuer Development” and “Pioneers” are in place to
                 strengthen local companies’ critical capacities in different growth phases. ProsperAr also assists
                 international companies to invest in and/or work with their local counterparts to form global joint
                 ventures.


                 ProsperAr is your strategic partner to invest and prosper in Argentina.




What ProsperAr can do for you:

                  Provide timely and relevant information on business sectors and geographical
                    locations in Argentina.
                  Help identify investment and innovation opportunities in strategic sectors.
                  Troubleshoot red tape and obstacles; facilitate the investment process and doing
                    business in Argentina.
                  Assist in building partnerships between foreign investors and local companies.


                                                                                                                           1
To learn more about how investing in
BIOTECHNOLOGY in Argentina
can benefit you, please contact us:

www.prosperar.gov.ar
info@prosperar.gov.ar
+54 11 4328 9510

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Invest in Argentina's Growing Biotech Industry

  • 1. INVESTMENT OPPORTUNITIES Biotechnology in Argentina Knowledge + Innovation to meet global market needs
  • 2. Photo: courtesy of INTI. National Institute of Industrial Technology
  • 3. Highlights FACING A GLOBAL OPPORTUNITY The global biotechnology market has been growing at a strong rate, driven by constant technological and scientific advances and broadening areas of application. Mainly concentrated in the U.S., the biotechnology industry presents attractive opportunities for those countries with the right set of resources. REMARKABLE DOMESTIC POTENTIAL Growing private and public RD activities, a pool of highly qualified human resources in biosciences, and developed pharmaceutical and food beverage industries put Argentina in a strong position to take advantage of growth in the global biotechnology market. PROMISING PERFORMANCE AND A WIDENING SCOPE As one of the regional leaders in the biotechnology industry, Argentina’s domestic sales and exports have grown significantly. Mainly focused on agricultural applications, local firms are currently making progress throughout all biotechnology application areas. MEETING GLOBAL DEMANDS By continuing to embrace biotechnology and its applications, Argentina will be able to meet an increasingly global and sophisticated demand for food and health products while protecting the environment for future generations. CHALLENGES AHEAD The main challenges for the growing local biotech market include furthering the integration of biotechnology with the overall economy; keeping up with the increasing demand for qualified human resources; increasing RD capacity; and improving public private sector coordination. May 009
  • 4. I. Why Invest in Biotechnology in Argentina? Photo: courtesy of Bio Sidus labs • HUGE POTENTIAL. Biotechnology consists in the • COMPETITIVE RESOURCES. The combination of application of science and technology to living growing private and public RD activities, a pool organisms, biological systems, or derivatives thereof, of highly qualified human resources in biosciences, to make or modify products or processes for the and well-developed pharmaceutical and food and production of knowledge, goods and services. Modern beverage industries put Argentina in a privileged biotechnology can substantially contribute to improve position to capitalize on existing global opportunities. human welfare and current living conditions by In particular, the large number of researchers (highest delivering essential outputs as pharmaceutical products per active person in Latin America), over 35 biosciences or vaccines and increasing both the quantity and quality research institutes within firms and universities, of food. doctoral and postdoctoral biotechnology training institutions, and a leading position in genetically • A THRIVING GLOBAL INDUSTRY. The global modified crop use, provide Argentina with strong biotechnology industry has been growing steadily, foundations to build a dynamic and sophisticated at a compound annual growth rate of 13% during biotechnology industry. 2000-2007. Despite worldwide economic turmoil, the industry sustained its solid performance in 2008, • PROFITABLE AREAS OF APPLICATION. Modern growing 12% in revenues to US$89.7 billion. While the biotechnology has applications in many fields, including U.S. accounts for over half of global revenues, other human and animal health, agriculture, fishing and countries are exhibiting significant growth rates. forestry, food processing, industrial processing, and Argentina is among those countries. natural resource extraction. At the global level, the health sector is the largest, representing almost • REGIONAL LEADERSHIP. Knowledge being the key two thirds of total revenues. The agriculture food component in the biotech industry, Argentina managed processing segments account for approximately to leverage its strong research capacity to host and 12%. Argentina has already established competitive create companies that use or produce biotechnology advantages in some niches within the industry, inputs. With over 80 established companies, Argentina particularly in agricultural, food and health segments. is the country with the highest amount of biotechnology The local market is especially focused on the production companies per capita in Latin America. Domestic of agricultural inputs, pharmaceutical products, human firms feature a wide range of activities, from the use diagnosis products and fine chemicals (amoniacids, of biotechnological supplies in production processes pigments, antibiotics and vitamins). to the manufacture of modern biotechnology products through recombinant DNA techniques.
  • 5. II. Industry Structure and Performance STRUCTURE INDUSTRY SEGMENTS Diverse and competitive sector. More than 80 A diverse array of products are being produced locally, firms produce modern biotechnological products locally, covering several areas of biotechnology applications. covering a wide range of activities: 29% of firms produce Agriculture, food processing, human heath and diagnosis, inoculants, 23% seeds and plant varieties, 12% animal and animal health are segments in which domestic health products, 12% food ingredients and 24% human biotechnology presents attractive competitive advantages. health products. The sector is composed of a mix of global players and growing domestic companies. Global leaders Agricultural sector. Within agriculture, biotechnology such as Bayer CropScience, Dow AgroSciences, Nidera, has many applications, including genetic modifications Monsanto and Pioneer are active in the country, and (GM) of plant varieties, seeds, inoculants, pesticides, local firms like Bioceres, Biocientífica, Biogénesis-Bagó, fertilizers, vet products and genetic selection for cattle BioSidus, Cassará, Indear and Wiener Lab are competitive breeding. The worldwide performance of GM crops stands players in diverse segments. Around 80% of firms are out, increasing its market size 65-fold in 1996-2008 to domestic small and medium size companies, focused US$7.5 billion. GM crops currently cover an area of 125 almost exclusively on biotechnological activities. million hectares in 25 countries in six continents. These figures are expected to double in the next ten years. INDUSTRY BUSINESS PERFORMANCE Sales and exports. Conservative estimations calculate GM Crop Area by Country biotechnology annual sales at US$400 million and China 3% Others 5% employment in the sector at more than 5,000 workers. The India 6% Canada 6% agricultural sector leads the sales by area of application: seeds and plant varieties concentrate 41% of total sales, Brazil 13% U.S. 50% animal health explains 25%, and inoculants add an additional 8%. The food ingredients sector accounts for Argentina 17% 15% of sales and human health for the remaining 11%. Biotechnology exports amount to over US$80 million Source: International Service for the Acquisition of Agri-biotech Applications (ISAAA) (60% in agro related activities and 24% in human health), Endowed with vast extensions of arable land (32 million resulting in a biotech trade surplus of over US$50 million. hectares), Argentina embraced, at an early stage, the use Seeds and plants and human health explain together 72% and generation of genetically modified crops, leading to of total employment, distributed in almost identical shares. an agricultural revolution that increased both the size of Private RD explains over 5% of sales, reaching some the cultivated land and the yields per hectare of its main US$20 million in total, with the highest ratio seen in human crops. Record-high levels of agricultural production health (15%). The number of patents presented to the U.S. are reached year after year. Argentina is today a leading Patent and Trademark Office (USPTO) ant the European country in adopting biotech crops: it has the highest Patent Office (EPO) by the Argentine biotech sector percentage of arable land planted with GM crops (65%), amounts to 53 and 12 per year in 2001-2007 respectively. it is the second largest producer of GM crops (21 million Biotechnology by Segment Share of total firms, sales, employment and exports Soybean Area and GM Soybean Evolution 100% 11 20.000 10 0 90 6 18.000 In thousand of hectares 80% 1 16.000 80 1 1 14.000 70 60% 1 11 12.000 60 10 0 10.000 50 % 0% 8.000 40 1 6 6.000 30 0% 0 4.000 20 8 8 4 2.000 10 0% - - Firms Sales Employment Exports 3 4 5 6 7 8 9 7 8 9 0 1 2 /0 /0 /0 /0 /0 /0 /0 /0 /9 /9 /9 /0 /0 02 03 04 05 06 07 08 00 96 97 98 99 01 Inoculants Seeds Plants Animal Health Food Ingredients Human Health 20 20 20 20 20 20 20 20 20 19 19 19 19 . Source: Bisang, Gutman, Lavarello, Sztulwark and Diaz (006) Source: CONABIA and SAGPYA Total soybean area GM soybean/ Total soybean
  • 6. hectares; 17% of world GM area) and enjoys top-notch DNA technology, including human erythropoietin, human productivity in soy, corn and their derivatives. Some interferons, colony-stimulating factors and human growth companies also produce bioinsecticides and pulse crop hormone. These products are already sold in Asia, the inoculants, while others use seedling micropropagation Middle East and Latin America. Argentina is, along and vegetable tissue culturing technologies. with the U.S., Australia, Korea and New Zealand, one of the few countries in the world with the technology of Food Processing. Argentina counts with a large and pharmaceutical diary. It is also one of nine countries with highly competitive food and beverage industry, with capacity to clone animals successfully. BioSidus is one total sales of US$53 billion (31% of total manufacturing of the sector’s leaders. In the field of diagnosis, there are production sales) and exports of US$21 billion (30% of products and developments using recombinant protein total manufacturing production exports). Significant and monoclonal antibodies to detect infectious diseases, applications of biotechnology are being developed such as Chagas’ Disease, Cholera, Hepatitis B and C, and implemented in this field. Biotechnology in food and HIV. There is also capacity for molecular oncology, processing is focused on the production of high-fructose leukocyte differentiation antigens, genetic predisposition to corn syrup and its intermediate product glucose syrup. hereditary diseases, and filiations and personal identity. Five companies stand out in this segment. While three of them are domestically-owned (Alimentaria San Luis, Sales of Domestic Pharmaceutical Production Arcor and Georgalos), the other two have been acquired by (in US$ million) 2.500 Exports global food companies (Industrias de Maíz and Refinerías Internal market 2.000 de Maíz). Two leaders in the dairy sector (SanCor and 1.500 La Serenísima-Danone) have recently launched their probiotic milk lines by incorporating Lactobacillus and 1.000 Bifidobacterium strains that, as probiotic species, favor the 500 intestinal microbacterial ecosystem. 0 2002 2003 2004 2005 2006 2007 2008 Source: National Institute of Statistics and Census (INDEC) Food Beverages: Production and Exports (in US$ million) 60.000 Production Animal health. The strong local pharmaceutical Exports 50.000 tradition and the knowledge generation in related areas 40.000 allowed for the production of transgenic cattle and animal 30.000 vaccines. Important progress was made in the areas of 20.000 animal food and health due to the active involvement 10.000 - of national and multinational companies present in 2002 2003 2004 2005 2006 2007 2008 Argentina. A salient case in the area of animal vaccines Source: Center of Studies for Production (CEP) is the production of the vaccine against bovine neonatal diarrhea caused by rotavirus. This vaccine was the result Human Health and Diagnosis. Applied biotechnology’s of a joint project between the Center for Animal Virology greatest impact in terms of industry has occurred in (CEVAN) and the National Council for Scientific and pharmaceuticals, where a long-standing tradition of Technical Research (CONICET). Other examples of public- biomedicine combines with a large domestic industry. private collaboration include the vaccines developed by With local pharmaceutical production growing at an the Virology Lab of the National Institute for Agricultural annual rate of 16% between 2002 and 2008, investments Technology (INTA) that were produced and marketed have increased 10 times during this period. Pharmaceutical by Biogénesis and San Jorge-Bagó labs. This sector also domestic companies have the capacity to develop new produces and markets vaccines against foot-and-mouth products covering all stages from product innovation disease and exports vaccines for salmons. Vilmax, a leading through commercialization, including pilot plant tests, company in the production of colorants, manufactures manufacturing, clinical trials and regulatory authority specific colorants to purify proteins. approval. Most products result from applying Recombinant 6
  • 7. CASE STUDY Bio Sidus: translating scientific breakthroughs into products for a better quality of life BioSidus, under the guidance of the pharmaceutical to ensure the perpetuity of the transgenic lineage. firm Sidus, has become a leading organization in Human growth hormone obtained from the milk the biotechnological field, thanks to the efficient of these transgenic cows has already been tested integration of both enterprise and technology. for bioequivalence against the bacterial-derived By the end of the 190s, the managing staff of reference product and is about to start efficiency “Instituto Sidus”, conscious of the central role clinical trials. The production of recombinant human of modern biotechnologies, decided to enter proteins in the milk of transgenic cows is expected in the biotechnological research field. In 1980, to be a highly efficient and cost-effective method Sidus’ Area of Biotechnology was created, compared to more traditional manufacturing under Sidus’ entrepreneurial support and the techniques, with the yield from only a small number scientific concurrence of an important group of of transgenic cows meeting market demand for professionals from the University of Buenos Aires. many medical applications. Additionally, BioSidus has The goals successfully achieved in technological developed lineages of transgenic cows to produce and manufacturing developments led Sidus in bovine growth hormone for veterinary use. However, 198 to create BioSidus as an organically individual the most ambitious target in this technological enterprise, which by 1990 had rolled out its first platform is the development of transgenic cattle for biogeneric product: erythropoietin. Almost 0 years human insulin precursor. To this day, eight cloned later, BioSidus commercializes locally and abroad transgenic cows were born which will be induced to seven recombinant proteins for use in human health: lactation in the coming months to assess presence erythropoietin, interferon alfa a and b, interferon of human insulin precursor in their milk. As from this beta 1a, filgrastim, lenograstim and somatropin. milk, the human insulin precursor will be purified to Additionally, BioSidus counts with a pipeline of homogeneity and submitted to an enzymatic cleavage multiple biosimilar candidates in different stages of to recover biopharmaceutical degree human insulin. development. Lead products in the pipeline include This will be of special significance because it will allow PTH 1-, interferon beta 1b and streptokinase. large quantities of product at an affordable cost to meet the increasing demand of insulin to treat the Over % of BioSidus revenues come from exports growing population of diabetes patients. to almost 0 countries in Latin America, Middle East, Eastern Europe and Asia Pacific (including India, Ongoing projects also include gene therapy targeting Thailand and Lebanon) holding a significant market angiogenesis of ischemic heart tissue. BioSidus has share in these territories. Furthermore, the company is developed and produced pharmaceutical grade filing for regulatory approval to distribute its products naked plasmid DNA codifying for the human protein in 10 additional countries through partnerships with vascular endothelial growth factor and has assessed local pharmaceutical firms. Its recently launched through preclinical testing in laboratory animals product, Interferon beta 1a, is rapidly gaining market that its injection into the cardiac muscle resulted in presence in different countries. increased growth of new blood vessels as well as in muscle regeneration. These findings led to conduction In addition, the company is taking steps to prepare of Phase I clinical studies currently underway with for its eventual commercialization in developed promising results. Phase II clinical trials are set to start countries. To achieve this goal, BioSidus is in the in 009. process of upgrading its manufacturing processes and refurbishing a new facility in line with U.S. FDA In collaboration with the Argentine Dirección Nacional and EMEA regulatory standards. To accomplish this, del Antártico, research has been conducted aimed BioSidus has entered into a strategic association with at the isolation and characterization of certain an U.S. based firm to distribute its current product microorganisms from the Antarctic territory that portfolio in the U.S.. are particularly adapted to extreme temperature. A novel species has been isolated and identified With significant investments in RD, BioSidus activities - Bizionia argentinensis, and its full genome has been include the development of expression systems to sequenced. In this sense, BioSidus is once again a produce, formulate and clinically test recombinant pioneer in genomics in Argentina since this is the proteins for human health. The company’s RD efforts first national experience of integral sequencing of focused on innovative transgenic biopharmaceutical a microorganism genome. The genome is currently manufacturing merit special mention. BioSidus has under analysis seeking for genes that encode for built up a pharmaceutical dairy comprised of a herd enzymes active at cold temperature. There is a great of cloned transgenic cattle, including twelve cows potential for industrial applications of these “cold producing biopharmaceutical grade recombinant enzymes” in the food, textile and laundry industries, human growth hormone in their milk and seven bulls among others.
  • 8. III. Foundation for Success LOCAL SKILLS AND TALENT financed courses for more than 2,400 students from Qualified human resources. Developing Argentina, Brazil, Uruguay and Paraguay biotechnology requires highly qualified human resources. Argentina is the country with the highest number of researchers per active person in Latin America (3.4/1,000 RESEARCH AND DEVELOPMENT active) and has internationally renowned scientific Research institutes. Research institutes from skills and a pioneering spirit. In natural sciences, this universities and companies carry out RD activities in tradition is evidenced by three Nobel Prizes awardees (B. a wide range of disciplines and specialties in Argentina. Houssay, L. Leloir and C. Milstein). In total, over 59.000 Almost 70 of these centers (41 companies and 27 research researchers and scholars undertake research activities groups) are focused on agricultural issues and 37 are both in the public and private sectors. These talents are dedicated to biosciences. Specifically, 28 are devoted also growing thanks to the Program RAICES, a strategic to biotechnology research, including public centers, project from the Ministry of Science and Technology university centers and private foundations. that promotes and facilitates the return of Argentine distinguished researchers working abroad. In the last few Regional hubs and business incubators. A recent years more than 600 professionals have been relocated in trend has been the emergence and consolidation local research institutions. of technological hubs and business incubators in different knowledge-intensive fields. A highlight within Specialized research and training. Today, 1,350 agricultural research is the Rosario biotechnological researchers and technicians undertake scientific hub in the province of Santa Fe. Comprised of several research in biosciences. Specifically, 241 scientists and institutions mainly devoted to vegetal biotechnology, 101 technicians are involved in biotechnological research the hub brings together more than 400 professionals, lines. More than 30 universities and higher education constituting the main biotechnological pole in Latin institutions offer undergraduate and graduate careers America. The Argentine-Spanish Center for Plant in biotechnology. Scientific researchers continue their Genomics (CEBIGEVE) and the National Institute for education through doctoral and postdoctoral scholarships Agro-biotechnology (INDEAR) are two of its members. sponsored by CONICET. Additionally, courses for CEBIGEVE is an RD center resulting from the scientific researchers coming from the public and private cooperation between Spain and Argentina. INDEAR, in sector are offered at the Argentine-Brazilian School of turn, results from the partnership between the private Biotechnology (EABBIO). From 1987 to 2003, EABBIO firms Bioceres and BioSidus and the CONICET. Photo: courtesy of Biogénsesis Bagó 8
  • 9. Photo: courtesy of Roemmers labs COMMUNITY INDUSTRY NETWORKING Public perception. Argentina has a positive public There are several organizations that promote perception of biotech products and a good acceptance biotechnology and communicate the sector´s news of transgenic organisms. The first genetically-modified and achievements in Argentina: crop in Argentina’s agriculture was glyphosate-tolerant soybean, approved in 1996. Since then, several crops • FAB (Argentine Forum on Biotechnology): and their features have been tested in the field, and with 20 years of continuous experience, the this type of technology has spread rapidly. In the last organization promotes biotechnology and agricultural campaign, they accounted for over 90% of cooperation and collaboration among researchers, soybean planted area, around 70% of corn planted area, companies and the government to fully develop and approximately 60% of the cotton planted area. At the biotechnology. government level, Argentina supports biotechnological undertakings, leveraging communication and information, • BIOTECSUR: a biotechnology platform that and improving controls to provide security to consumers. brings together the private, academic and public sectors from the four countries of MERCOSUR and works to establish a common long-term vision for the development and application of new Sowed Area by Type of Crop technologies in the region. (in thousands of hectares) • ASA (Argentine Association of Seed Traders): 30,000 GMO’s Conventional it has a proactive attitude to spread biotechnology 25,000 20,000 through the “Por qué Biotecnología” (Why 15,000 Biotechnology?) program. 10,000 5,000 • RedBio (reporting to Food and Agriculture - Organization): responsible for a communication 3 4 5 6 7 8 7 8 9 0 1 2 campaign at primary, secondary and tertiary /0 /0 /0 /0 /0 /0 /0 /9 /9 /9 /0 /0 00 02 03 04 05 06 07 96 97 98 99 01 20 20 20 20 20 20 20 20 19 19 19 19 Source: Argentine Association of Seed Traders (ASA) and Secretariat of Agriculture, Livestock, fishing and Food (SAGPYA). educational levels. 9
  • 10. IV. Policy Initiatives Photo: courtesy of INTI. National Institute of Industrial Technology BUSINESS PROMOTION investment, and biotechnology has always been a priority Incentives. Government, private companies and topic during the last decades. These tools have been research institutions are working together in the deepened since the creation in 2007 of the Ministry promotion of modern biotechnology. Law 26,270 of Science and Technology. Within the Ministry, the sets promotional measures that are related to human National Agency for Scientific and Technological resources and capital expenditures during RD and Promotion (ANPCyT) encourages scientific, technological production of technologies applicable to several and innovation-related activities with resources coming productive areas. The law’s main benefits, which are in from contributions from the national budget and the process of being regulated by the technical authorities, Inter-American Development Bank (IDB). The two include accelerated amortization of the income tax, main Agency funds are the Fund for Scientific and early reimbursement of Value Added Tax, and tax credit Technological Research (FONCyT) and the Argentine bonds for contributions to the social security and services Technology Fund (FONTAR). purchased from government-owned research institutes. It also establishes the development of a special fund for new undertakings. Innovation resulting from the benefits of the scheme shall be, in the first place, patented by the National Agency for Scientific and relevant domestic patent offices. Technological Promotion (ANPCyT) Venture capital. Government is increasingly involved Fund for Scientific and Technological Research (FONCYT): Supports research projects targeted in the promotion and development of venture capital at generating new scientific and technological funds for technology-based companies in Argentina. knowledge. Promotion and financing instruments are The Ministry of Science and Technology has put in place awarded, in all cases, through public bids. The FONCyT has sponsored an important number of projects in the the Program CREARCIT to encourage the growth and area of biotechnology between 00 and 008, for creation of innovative firms in all technological fields over US$ million. through venture capital investment. Argentine Technology Fund (FONTAR): Supports projects targeted at improving the private sector productivity on the basis of technological innovation. SCIENTIFIC PROMOTION There are various financing instruments granted Funds for RD. The national government has through public bids or permanent window. The implemented several programs and instruments that FONTAR has approved biotechnological projects for over US$1 million in 00-006. promote and facilitate basic research and technological 10
  • 11. REGULATORY FRAMEWORK Promoting and protecting health. The National Environmental and health safety. In Argentina, Administration of Drugs, Foods and Medical Technology GMOs are evaluated before these products are marketed. (ANMAT) promotes and protects human health by Since 1992, 400 field trials for different transformation assuring the quality and efficacy of medical products, events have been assessed and authorized. The food and domestic-use products, medical and diagnosis evaluation process includes three steps. First, the devices. Since 1992, the Ministry of Health is in charge of National Advisory Committee for Agricultural providing authorization for release to the market. Biotechnology (CONABIA) evaluates the likely impact on the agricultural ecosystem, comparing potential Intellectual Property Rights. As a signatory of the environmental consequences with those of conventional Trade-Related Aspects of Intellectual Property Rights plants, initially through experimental release and then agreement (TRIPS), Argentina provides an effective more extensive release into the environment. Second, patent protection system, including pharmaceutical the National Service of Agricultural and Food Health products. The National Institute of Industrial Property and Quality (SENASA) conducts a food safety evaluation. (INPI) made significant progress in reducing its patent Third, the National Direction for Agricultural Food backlog, including the implementation of fast-track Markets (DNMA) makes an evaluation of potential procedures and a one-time opportunity in 2005 for commercial impact by analyzing the status of the GM companies to prioritize their patent applications before product under study in the destination markets in terms INPI. FONTAR offers subsidies to SMEs to apply for of whether the product has been approved or not and, as patents both locally and abroad. a result, whether the addition of a GM crop to Argentina’s exports might represent a potential barrier to access these markets. To date, 10 GM crop varieties have been authorized for sale. Photo: courtesy of Biogénsesis Bagó 11
  • 12. V. Main Challenges Industry players and government agencies face key challenges to sustain growth and consolidate the sector’s competitiveness. In themselves, these challenges present attractive opportunities for the industry and Argentina. • Increase the availability of qualified human resources: an increasing domestic and international demand for Argentine biotech products will require expanding the current RD capacity in human resources and facilities on which Argentina sustains its competitive advantage. • Consolidate and expand its leadership in the use and development of GM crops: Argentina’s substantial use of GM crops presents a vast area of application for biotechnology, which must be consolidated as a driver for local industry growth. • Promote and foster the integration of biotechnology research centers with companies: the adequate institutional processes must be developed to further close the gap between research in biotechnology and its technology transfer to the demanding industries. • Establish efficient interaction mechanisms between the public and private sectors: achieving a balanced growth within the industry will require strengthening the strategic cooperation among firms and government agencies. • Develop and provide biotechnological solutions to regional economic activities: regional activities like wine and fruit production could surely benefit from the application of new biotechnologies. OUR CHALLENGES ARE YOUR OPPORTUNITIES. 1
  • 13. Photo: courtesy of INTI. National Institute of Industrial Technology SOURCES: The trends, data and figures included on Global Status of Biotech/GM Crops, 008 / The information provided through this brochure in this material were elaborated by ProsperAr Ministry of Science and Technology (MINCYT) / does not in any way constitute legal or based on information provided by: Argentine National Institute of Statistics and Census (INDEC) professional advice. ProsperAr (Agencia Nacional Association of Seed Traders / Argentine Forum on / National Observatory for Science Technology de Desarrollo de Inversiones) reserves the right Biotechnology (FAB) / BiotecSur / Bisang, Campi and Innovation, Strategic Plan, 00 / OECD, to revise, amend, alter or delete the information and Cesa, “Biotecnología y desarrollo”, CEPAL, Biotechnology Statistics, 006 / Sánchez, provided herein at any time and in no way be 009 / Bisang, Gutman, Lavarello, Sztulwark and Rozemberg, Butler and Rufo, “The emergence held responsible or liable in respect of any such Diaz (comp.) “Biotecnología y desarrollo. Un of new successful export activities in Argentina: revisions, amendments, alterations or deletions. modelo para armar”, UNGS-Prometeo, Buenos self-discovery, knowledge niches, or barriers to Aires, 006 / Center of Studies for Production riches?”, IDB, 008 / Secretariat of Agriculture, Cover photo: courtesy of Roemmers labs. (CEP) / Ernst Young, Beyond Borders: Global Livestock, fishing and Food (SAGPYA). Biotechnology Report 009 / ISAAA Report 1
  • 14. Argentina at a glance Country profile Official name República Argentina Capital city Buenos Aires Main cities Córdoba, La Plata, Mar del Plata, Mendoza, Rosario Surface area . million square kilometers Population 0.6 million inhabitants Population growth 1.0% per year Adult literacy rate 98% Life expectancy at birth years GDP per capita (PPP) US$ 1,1 Currency Argentine peso ($) Form of government Federal Presidential Republic Political division autonomous provinces and the Autonomous City of Buenos Aires Time zone GMT-0:00 Official language Spanish Main Economic Indicators 00 00 00 006 00 008 GDP growth rate (annual %) 8.8% 9.0% 9.% 8.% 8.% .0% GDP (PPP) (millions of US$) ,99 ,01 19,68 69,0 ,10 ,860 GDP (millions of US$) 18,08 1,18 181,96 1,868 60,68 8,0 Exports of goods and services (millions of US$) ,9 9,86 ,0 , 66,088 8,608 Imports of goods and services (millions of US$) 18,8 ,90 ,99 1,10 , 6,9 Balance of trade of goods and services (millions of US$) 1,61 11,9 1,08 1, 1, 1,11 Trade surplus (% of GDP) 1.% .8% 6.6% 6.% .9% .6% Current account surplus (% of GDP) 6.% .1% .9% .6% .% .% Primary fiscal surplus (% of GDP) .% .9% .% .% .% .1% Gross capital formation (% of GDP, constant prices) 1.% 1.% 19.8% 1.6% .6% .0% Gross national savings (% of GDP, current prices) 19.6% 0.6% .% 6.% 6.6% 6.%E Foreign direct investment (millions of US$) 1,6 ,1 ,6 , 6, ,99 Exchange rate ($/US$) .9 .9 .9 .0 .1 .16 Foreign reserves (millions of US$) 1,119 19,66 8,0 ,0 6,16 6,86 Unemployment rate (% of EAP) 1.% 1.6% 11.6% 10.% 8.% .9% Source: ProsperAr based on data provided by the Argentine National Institute of Statistics and Census, the Central Bank’s Market Expectations Survey (REM), the International Monetary Fund and the United Nations Conference on Trade and Development (as of April 0, 009). 1
  • 15. ProsperAr is Argentina’s National Investment Development Agency Our mission is to develop direct foreign and domestic investment to contribute to Argentina’s competitiveness and sustainable development. ProsperAr’s four main objectives are: Provide services to investors ProsperAr provides investors with personalized professional services throughout the investment process, from initial advisory services to investment facilitation and aftercare. The Agency’s team assesses on investment projects, responds to queries from investors and provides key business information. Leveraging the Agency’s cooperative relationships with different government bodies, ProsperAr’s integral services offer investors a unified one-stop support system. Attract and generate investment ProsperAr works in the promotion, attraction and expansion of both domestic and foreign investment. We identify investment and innovation opportunities in high growth sectors, communicating them to national and overseas investors through international missions, conferences, meetings and publications. We work to build relationships that enable multinational companies to take advantage of local, regional and global opportunities. We also encourage domestic firms to expand and develop their businesses. Boost the Investment Environment ProsperAr works to strengthen Argentina’s investment environment. We interact with local and multinational companies, as well as potential investors, identifying and removing possible obstacles to doing business in Argentina. Through active dialogue with the private sector, and in coordination with other government departments, we advocate for the formulation of policies and programs to optimize the investment and innovation environment. Promote the internationalization of local companies ProsperAr promotes the growth and internationalization of Argentine firms. Fostering local vocation for innovation and entrepreneurship and promoting overall competitiveness are key aspects of the Agency’s strategy. Two programs “Entreprenuer Development” and “Pioneers” are in place to strengthen local companies’ critical capacities in different growth phases. ProsperAr also assists international companies to invest in and/or work with their local counterparts to form global joint ventures. ProsperAr is your strategic partner to invest and prosper in Argentina. What ProsperAr can do for you: Provide timely and relevant information on business sectors and geographical locations in Argentina. Help identify investment and innovation opportunities in strategic sectors. Troubleshoot red tape and obstacles; facilitate the investment process and doing business in Argentina. Assist in building partnerships between foreign investors and local companies. 1
  • 16. To learn more about how investing in BIOTECHNOLOGY in Argentina can benefit you, please contact us: www.prosperar.gov.ar info@prosperar.gov.ar +54 11 4328 9510