Clinigene to be third party CRO

Clinigene International, a wholly-owned subsidiary of Biocon, is being positioned as a third party clinical research organisation (CRO) and hopefully the preferred one for new drug molecules.

The company since its inception in 2000 has been helping parent Biocon in clinical research and development. Now after gaining in size and expertise, it is all set to operate as third party CRO.

"Clinigene has been focussed in building its capability base and today is in a strong position to launch itself as a third party clinical services company," said Kiran Mazumdar Shaw, chairman and managing director, in her director's report to shareholders of the company.

The company plans to offer a range of services encompassing bioequivalance, bioavailability studies as well as undertaking phase I to phase IV clinical trials.

During financial year 2004-05, the company's human pharmacology unit completed several bioequivalance and bioavailability studies for a number of global pharmaceutical companies, said Kiran Mazumdar Shaw.

After successfully conducting phase III clinical trials for recombinant human insulin for Biocon, Clinigene is presently conducting IIB trials for novel anti-EGFr monoclonal antibody for head and neck cancers. According to her, this is the first such study being undertaken for a new antibody in the country.

Talking about Syngene International, another subsidiary of Biocon, Kiran Mazumdar Shaw said, the business of research services represents a significant growth opportunity for the future based on rapidly growing needs for outsourced research services.

In the financial year 2004-05, the company enrolled a number of new customers, the most significant being Novartis which sees Syngene as an important research partner in its discovery-led programmes.

With its new facility fully operational, the company expects to drive strong growth in financial year 2005-06, she said.