The Hindu Business Line : Zenotech bets big on biological entities

Future plans
The one-year contract would lead to the development of the E. coli (bacteria), based, wound healing product
Plans are to file at least 14 Abbreviated New Drug Applications in the US
It has set a target of filing of 40 ANDAs by 2009, including with Ranbaxy

M. Somasekhar

Hyderabad, July 3 Zenotech Laboratories Ltd (ZLL), the specialty generic injectables company, is betting big on new biological entities (NBEs), especially in cancer treatment, to propel its growth in the near future.

The Hyderabad-based company, which recently tied up with Ranbaxy Laboratories for its first biosimilar product, G-CSF (Filgrastim), has also won the country’s first CRAM (contract research and manufacturing) project in biotech from the New York University for a wound healing product.

According to Dr Jayaram Chigurupati, Chief Executive Officer of ZLL, the contract involves developing the cost effective process and toxicity studies for the patented recombinant protein (an NBE). The final product ready for clinical trials would be given back to the New York University.

The one-year contract, the size of which he did not disclose, would lead to the development of the E. coli (bacteria), based, wound healing product. Once, the clinical trials are through and the product ready for commercial launch, ZLL would also have the worldwide manufacturing rights, he told Business Line.

Andas filing

Stating that the global clinical development and marketing agreement with Ranbaxy for C-GSF, used in preventing infections from cancer chemotherapy-induced neutropenia (decrease in a type of white-blood cells), has yielded nearly Rs 9 crore in the last few months, Dr Jayaram said plans are to file at least 14 ANDAs (Abbreviated New Drug Applications) in the US with the Indian major by 2009.

The first of the ANDAs (covering specialty injectables and oncology) is expected to be filed by Ranbaxy in October-November 2007. “We have a profit sharing, marketing rights agreement and expect revenues to flow in from fiscal 2008-09,” he said.

ZLL has set a target of filing a total of 40 ANDAs by 2009, including with Ranbaxy. The alliance with Ranbaxy has helped in terms of documenting, filing and development of ANDAs for regulatory markets. Also funding is no longer a major issue, Dr Jayaram said.

The company has invested over Rs 100 crore in creating R&D and manufacturing facilities, compliant to USFDA standards on a 50-acre plot near the Biotech Park on the outskirts of Hyderabad.

ZLL has developed a generic monoclonal antibodies technology platform, which it is using to develop NBEs and biosimilars (which are generic versions of biotherapeutics using recombinant DNA technology), he added.

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