Beyond Borders: Global biotechnology report 2010

Biotech will provide the technology and
intellectual property developed by Cuba’s
Center for Genetic Engineering and
Biotechnology, and EMS Sigma Pharma
will develop production capabilities while
providing infrastructural and logistical
support for the global distribution of the
resultant products. EMS Sigma Pharma
entered another agreement with two
Shanghai-based laboratories, Biomabs
and Guijian, to gain a technology platform
for the production of the rheumatoid
arthritis treatment etanercept. Under
this agreement, the company is also
expected to acquire a technology platform
to manufacture five more monoclonal
antibodies in the future.
FK Biotecnologia entered an agreement with
Canada-based ZBx Corporation to conduct
the clinical development of FK’s pipeline
vaccine for prostate cancer. FK plans to
initiate Phase III trials to seek marketing
approval of this vaccine by 2010. Two other
Brazilian companies, Biocancer and Genoa
Biotecnologia, also have anticancer vaccines
in clinical trials, and the companies are
currently seeking partnerships to further
develop these products.
Financing and investments
There are relatively few Brazilian venturecapital
firms that are actively investing
in high-risk biotechnology. Consequently,
Brazilian biotech companies largely rely
on Government grants and income streams
from services. Currently, the Government
accounts for around 65%–70% of total
R&D expenditures.
Stem cell research has been attracting
investments from the Government and
private players. In February 2009, the
Government announced plans to construct
eight laboratories for stem cell research.
The National Bank for Economic and Social
Development (BNDES) and Brazil’s Ministry
of Health, Science and Technology have
funded the project with a total investment
of R$23.6 million (US$12.5 million).
Several global life sciences companies
entered Brazil in 2009 to tap the domestic
market’s potential and leverage its lowcost
advantages. Belgium-based UCB
collaborated with AstraZeneca
to commercialize UCB’s PEGylated
anti-TNF alpha drug, Cimzia, in Brazil.
In another similar agreement, BurnsAdler
Pharmaceuticals — a US-based distributor
specializing in marketing products throughout
Latin America — announced plans to market
Three Rivers Pharmaceuticals’ Hepatitis C
infection therapy, Infergen (type 1 interferon
alpha), in Brazil and Chile.
Roche has also made significant strides in
the Brazilian biopharmaceutical market.
During 2009, the company launched the
chronic renal anemia drug Mircera and
the rheumatoid arthritis drug Actemra in
the Brazilian market. Roche’s subsidiary
in Brazil, which is being developed as an
export-oriented arm to provide low-cost
drugs to European markets, invested US$50
million in clinical research in 2009. It also
began production at its US$85 million plant
in Rio de Janeiro.
Accompanying the flurry of global
inbound investments were investments
by domestic players in production and
marketing capabilities. São Paulo-based
pharmaceutical company Uniao Quimica
announced plans to invest R$150 million
(US$85.5 million) to set up an insulinmanufacturing
plant in Brasilia. Another
Brazilian pharmaceutical company,
Cristalia, has begun construction of a new
biotechnology unit in Rio de Janeiro to
manufacture human growth hormones
and interferon. The company has already
48 Beyond borders Global biotechnology report 2010
invested R$20 million (US$35.5 million) in
the project and plans to invest an additional
R$25 million (US$44.3 million) in the
new facility.
Over the past few years, leading global
contract research organizations have been
building operations in Brazil to benefit
from the country’s cost advantages, strong
patient pool and quality resources. US-based
Covance entered the Brazilian market with
the launch of a new clinical development
office in São Paulo. According to Covance,
the new facility is expected to support
personnel in Brazil, Central America and the
Caribbean as well as the network of fieldbased
clinical research associates. Another
clinical development services provider,
PharmaNet Development Group, also
recently established an office in
São Paulo to strengthen its
Latin American presence.
Regulatory challenges
The regulatory structure of the
Brazilian biotechnology industry is fairly
complicated, with different laws and
regulators governing various segments
of the industry. Brazil’s National Health
Surveillance Agency (ANVISA) regulates
health products, including those produced
using biotechnology techniques.
ANVISA’s General Office of Drugs and
the General Office of Research, Clinical
Trials, Biological, and New Drugs holds
the authority to approve clinical trials
conducted in the country. In addition, the
National Commission for Ethics in Research
(CONEP) focuses on ethical considerations.
The Council for Management of Genetic
Patrimony (CGEN), which is affiliated
with the Ministry of Environment (MMA),
protects biodiversity. And two separate
bodies — the National Biosafety Council
(NBSC) and the National Biosafety Technical