[Commons-Law] Small Indian biotech companies make it big with off-patent drugs

[Prabhu Ram]

Small players make it big with off-patent drugs

P B Jayakumar / Mumbai April 30, 2007



Competing with established biotech companies in India such as
Wockhardt, Biocon and Reliance Life Sciences, small biotech companies
such as Zenotech, BV Biocorp and Intas Biopharma are likely to emerge
as major Indian players in the field of biogeneric drugs, copycat
versions of off-patent biotech drugs.

The biogenerics market is expected to grow to $25 billion in Europe
and $30 billion in the US by 2015 as many existing blockbuster biotech
drugs are going off-patent in the coming years.

BV Biocorp, the biotech drug research arm of the Pune-based poultry
major Venkateswara Hatcheries (VH) group, is close to launching three
biogeneric drugs in the global markets even ahead of players such as
Reliance Life Sciences.

While biogenerics of Reliance Life Science's recently acquired a UK
facility, GeneMedix, Wockhardt, which has developed six biogenerics,
is yet to decide on launching its product in the US market.

"Our biogenerics are in the therapeutic areas of cancer, arthritis and
cardiovascular diseases. Two of the drugs are undergoing phase-III
clinical trials in the US and India and the third drug will soon enter
the phase-III trials. The drugs have shown excellent results so far
and could be commercialised within a year," said O P Singh, chief
executive officer, VH group.

BV Biocorp is also setting up three plants for drug manufacturing with
an investment of Rs 43 crore at the Rajiv Gandhi Biotech Park at
Hinjewadi and at the special economic zone in Pune. "We may set up two
to three plants depending on the requirement or may even opt for the
inorganic route to scale up the production facilities depending on the
demand for products," he said.

Intas Biopharmaceuticals, another emerging player, already markets
indigenously developed biopharmaceutical products such as recombinant
human Granulocyte Colony Stimulating Factor (G-CSF) under the brand
name of Neukine, Erythropoietin (EPO) under the brand name of Erykine
and Epofit and Interrferon Alfa 2b as Intalfa in India. Six more
products are in the pipeline and the company hopes to launch one to
two products every year in the coming years, according to Mani Iyer,
director, Intas Biopharmaceuticals.

The generic opportunity for EPO (for chemotherapy and renal failure),
GCSF (prescribed to make more white blood cells during cancer
treatment), Interferon Alpha (for Hepatitis C and renal failure),
Interferon Beta (to treat multiple sclerosis, a chronic disease that
affects central nervous system) and human insulin, together with a
current market size of $7200 million, is estimated to have a market
size of $7 billion alone in Europe by 2015. The European Union has
already enforced guidelines for allowing biogenerics and the US is
actively considering to approve marketing of biogenerics.

Zenotech, which developed its own versions of cancer drugs AGM-CSF and
G-CSF, has three other biogenerics under development. The company also
has developed generic rituximab, a biotech drug used to treat a type
of cancer called non-Hodgkin's lymphoma. Zenotech is also developing
interleukins (IL-2), used in cancer treatment to stimulate white blood
cells. The company, which sold its 10 per cent stake to Ranbaxy, has
teamed up with the same pharma major to market its products in the
global markets.