The Hyderabad-based Zenotech Laboratories, an emerging specialty company focusing on therapeutics, is setting up a US FDA approved biologicals manufacturing facility at Shapoorji Pallonji Biotech Park at Hyderabad. The company is making an investment in the tune of Rs 35 crore.

Dr Jay Chigurupati, chief executive officer of Zenotech Labs told Pharmabiz that the manufacturing facility is expected to be commissioned in the third quarter of 2005. The facility will manufacture bacteria and mammalian cell culture products and parenterals in the new facility.

Zenotech develops and manufactures generic biopharmaceuticals, develops new biological entities in the areas of oncology, gynaecology and neurology.
Zenotech also offers comprehensive services for generating and characterizing recombinant proteins.

It will be launching the country's first recombinant human granulocyte marophage-colony stimulating factor (GM-CSF), a biotech product relating to oncology, this year. Meanwhile, the clinical trials for GM-CSF have been completed up to 60 per cent. The market size for GM-CSF in the domestic markets will be in the tune of Rs 30 crore.

The company has achieved approvals to conduct clinical trials for Interlukin 2 (IL-2). Animal Toxicity studies have been completed for IL-2. It is conducting clinical trials for recombinant human granulocyte colony stimulating factor (hG-CSF) product. Trials are on at 15 centres across the country.

The company is also rolling out a range of generic monoclonal antibody therapeutics. Zenotech has earlier received DBT clearance for a generic version of Genetech's $ 1 billion Rituxan.

Zenotech has set up base in Brazil and Vietnam, and is making significant plans in about 15 countries that are emerging markets. The company plans to license its products to partners who have knowledge of both patent situations and markets. To be quick to reach the markets with products, joining hands with partners with expertise is the best solution, he opined. It is also geared up to foray into the US and Canada markets. It is working with a US partner, which will get the company's products into US markets.

Scientists at Zenotech have already initiated drug discovery, and the company has currently a couple of drug discovery projects in hand.

Mentioning about the regulatory status of biogenerics in the US, Dr Jay added, biogenerics segment is evolving gradually. Both the US Congress and the US FDA have shown keen interest in working on it. In one year's time regulations will be in place, as consensus is evolving. It is a good sign to all the biogeneric companies that have been holding their plans to develop new biogenerics.

In India, many big pharma companies have entered into generics, but the size will not really matter here. Even a small company focusing on niche areas can also succeed. In the new patent regime, in-licensing will be key to all the generic players. Though it is new to India, but soon Indian generic companies will realize the potential in in-licensing, as it can offer sustainable growth, he said.