Beyond Borders: Global biotechnology report 2010

acquired US-based hybrid sorghum seed
producer Crosbyton Seed Company
to strengthen its position in the US
sorghum market.
In January 2010, Transgene Biotek entered
into a licensing and technology transfer
agreement with Dr. Reddy’s Laboratories for
manufacturing obesity-management drug
Orlistat. Also in January, Saamya Biotech
(India) Ltd. entered into a joint venture with
Malaysian firm Perak Bio Corporation to set
up a biopharmaceutical manufacturing unit
in Malaysia.
An increasing number of global
biotechnology companies are eyeing India
as an important destination for executing
their cost-cutting measures in response
to restrictive capital markets and the
need to increase efficiency. There has
been a significant spurt in deals involving
outsourcing, technology transfer and entry
of foreign players to tap a burgeoning
Indian biotechnology market. Bristol-Myers
Squibb and Biocon’s subsidiary Syngene
announced the opening of their integrated
drug discovery and development center at
Biocon Park in March 2009. This 200,000
square-foot facility will house around
360 researchers and will span the drug
discovery and development process from
lead optimization up to Phase I and Phase
II clinical studies. India’s leading contract
research and manufacturing service
(CRAMS) player, Jubilant Organosys,
entered a contract research agreement
with US-based Endo Pharmaceuticals to
develop preclinical candidates for oncology.
In September 2009, Biocon entered
an agreement with US-based Amylin
Pharmaceuticals to develop diabetes
products. The company also entered a
partnership with global generic drug maker
Mylan to manufacture and commercialize
several generic biotech drugs globally.
Meanwhile, several European biotechnology
companies, such as Germany-based
Biobase and UK-based Oxygen Healthcare,
Crystec Pharma and Lena Nanoceutics,
have announced plans to outsource their
manufacturing through collaborations with
Indian companies.
Biosimilars: the next big opportunity
Indian biopharmaceutical players have
developed strong capabilities in the
high-potential biosimilar space and have
presence in almost all the biologics coming
off patent. Companies such as Reliance
Life Sciences, Biocon, Wockhardt, Shantha
Biotech, Panacea Biotech and Intas
Pharmaceuticals have been developing
strong capabilities in this area. Biocon
expects to bring its oral insulin to the US
market by 2011 and has other biologics
such as G-CSF and various monoclonal
antibodies in its pipeline. Biocon is also
expanding the application of its head and
neck cancer monoclonal antibody, BIOMAb
EGFR, and has launched cervical cancer
clinical trials for this drug. Reliance Life
Sciences recently launched its fourth
biosimilar product, TPA Reteplase, in the
domestic market and plans to launch three
more products in 2010. The company also
has approximately nine biopharmaceutical
products in preclinical and clinical
development. Cipla formed a joint venture
called Biomab with a Chinese company for
manufacturing of biosimilars. Dr. Reddy’s,
which has filgrastim (G-CSF) and rituximab
in the market, claims to have a pipeline of
eight generic biopharmaceuticals in various
stages of development, including two in
clinical development.
Although Indian companies seem
well-positioned, they will likely face strong
competition from large cash-rich generics
firms such as Teva Pharmaceuticals, Mylan
and Sandoz. Moreover, taking biosimilar
drugs into developed markets is likely to
38 Beyond borders Global biotechnology report 2010
involve strong regulatory challenges due to
a potential requirement for submitting noninferiority
clinical trial data — which could
require large expenditures. In addition,
strong marketing clout will be required to
effectively compete with large numbers of
biosimilar brands. As such, it is likely that
Indian companies will partner with larger
players to navigate these challenges.
Outlook: the opportunities ahead
In recent years, the Indian biotech sector
has been gradually transforming from
fee-for-service provider to a strategic partner
for the global biotechnology industry — a
trend that continues with some significant
recent deals between Western and Indian
companies. As Western companies recover
from the financial crisis and focus on
opportunities in newer geographies and cost
optimization, we could see more acquisitions
of Indian biotechnology companies,
particularly those in niche segments or
having specialized innovative and/or
manufacturing capabilities.
Still, challenges remain. The industry
urgently needs a streamlined regulatory
structure to continue to attract investments
from foreign companies. To move up
the value chain, Indian companies will
increasingly need to develop novel drugs — a
challenge because of the lack of sufficient
venture capital.
The Indian biotechnology industry has
come a long way and continues to grow
even amid the global downturn as Western
companies seek opportunities to lower
costs and boost R&D efficiency. But to seize
the next wave of opportunities — from the
evolving biosimilars space to establishing a
presence in developing novel drugs — Indian
companies, investors and policy-makers will
need to focus on addressing some of the
critical challenges identified above.