Zenotech gets nod for generic products
JEETHA D'SILVA
Times News Network, Feb 15, 2005

Hyderabad-based Zenotech Laboratories will soon roll out a range of generic monoclonal antibody therapeutics. Many of them will be among the country’s first generic monoclonal antibody products.

The company has just received clearances for a generic version of Genentech’s $1bn Rituxan (protein’s name Rituximab).

Speaking to ET, Jayaram Chigurupati, CMD, Zenotech Laboratories, said, “We have recently obtained the approval of the department of biotechnology (DBT). The product, which will be the first generic, will hit the market in mid-’06.”

The protein Rituximab was the first therapeutic monoclonal antibody to treat cancer to be approved by the US Food & Drug Administration in November 1997.

“During the same year, Genentech launched Rituxan to treat relapsed or refractory low grade or follicular B-cell non Hodgkins lymphoma,” Mr Chigurupati said.

Each vial of the drug is currently available at Rs 80,000 and the total cost of therapy with this drug could go up to Rs 5 lakh, with most patients requiring about six vials, he added.

“We will launch the generic version at a much cheaper rate,” he said.

The product is currently sold in India by the Swiss multinational, Roche. Zenotech Laboratories has just received necessary regulatory clearances to conduct pre-launch clinical studies.

The toxicity studies will soon be conducted at the Indian Institute of Toxicology, Pune, which could take three months. These will be followed by Phase III clinical trials, which could take six months.

Zenotech Labs is planning to launch its first product — the country’s first recombinant human granulocyte macrophage-colony stimulating factor (GM-CSF) biotech product relating to oncology — by mid-’05.

Mr Chigurupati said, “The market size for GM-CSF is pegged at Rs 30 crore on the domestic front.”

The company is simultaneously conducting clinical trials for recombinant human granulocyte colony stimulating factor (hG-CSF) product. Trials are on at 15 centres across the country. Zenotech Labs is also working on yet another biotech product, interleukin-2 (IL2).

“Apart from domestic markets, we will also look at emerging markets like Brazil, Russia and Mexico. Early this year, we have opened our subsidiary company in Brazil. The product will simultaneously hit domestic and Brazilian markets in mid-’06,” he said.

The former chief of Dr Reddy’s Labs Emerging Businesses’ strategic business unit turned entrepreneur plans to set up a second production facility for monoclonal antibodies.

The Rs 50-crore facility will be commissioned by early ‘07. Zenotech Labs had acquired 35 acres of land near Shapoorji Pallonji Biotech Park in Hyderabad where its first facility is nearing completion.

Set up at a cost of Rs 30 crore, the facility will be commissioned by June this year. The company raised Rs 9 crore term loan from APSFC and Rs 15 crore through equity capital.