Biocon Ltd has signed a letter of intent to export recombinant human insulin to Bristol Myers Squibb. It is the first Indian company to have filed a Drug Master File with the US FDA for recombinant human insulin, informed Kiran Mazumdar-Shaw, chairman and managing Director, Biocon.

Biocon is one of the few companies that have scaled up recombinant human insulin to a commercial scale. It has completed Phase III clinical trials and is currently awaiting regulatory approvals for Insugen, which is slated to be launched in Q3 2004. Currently the Insugen approval for the Indian markets is awaited from Genetic Engineering Approval Committee (GEAC). The company has already hired 80 medical representatives for marketing the product.

Another development is the commencement of clinical trials for a novel human monoclonal antibody (MAB) for EGF (Epidermal Growth Factor) for the head and neck cancer cases is slated for July 2004.The trials will be held at Kidwai Memorial Institute of Oncology and the Curie Centre of Oncology in Bangalore.

For the MAB Biocon entered into a joint technology development with the Centre for Molecular Immunology, a Cuban-based monoclonal antibody and cell culture technology major for the research and production of a novel drug for head and neck cancer. The joint venture, which is a 51:49 partnership has ensued the development of an anti EGF human monoclonal antibody through technology transfer and a joint technology development including clinical studies, Shaw, chairman said. "We are taking it for Phase I, II and III trails through Clinigene International and then scale-up the product," she added.

As a part of its major growth strategies, Biocon recently launched a range of branded formulations targeted at the cardio-diabetes therapeutic segment. This includes 11 formulations based on Atorvastatin, Glimeperide, Losartan and Ramipril.

It has also received US FDA acceptance for its Pravastatin, Simvastatin, Lovastatin and Pioglitazone manufacturing facilities. "This acceptance from the US regulatory body will allow us to access the lucrative US$ 6 billion market slated to go off patent in the United States in 2006," said Shaw. Biocon has already established itself as a leading exporter of Lovastatin to the U.S. and Simvastatin to Europe.

Between March 2003-04, 88 Patent PC applications were filed and Biocon has become the third largest corporate enterprise in the country to achieve this, stated Shaw.

Biocon's clinical research focused subsidiary Clinigene which opened a state-of-the-art Human Pharmacology Unit at Sagar Apollo Hospital at Bangalore will now enable it to conduct Phase I clinical trials and bio-availability (BA) and bio-equivalence (BE) studies on healthy human volunteers in compliance with global ethical and regulatory standards.

Its other subsidiary Syngene is on the verge of completing construction of its 80,000 sq.ft. facility to cater to the expanding needs of providing research services to a global clientele. Currently, outsourced pharma research presents a substantial global opportunity for high quality service providers and Syngene's expertise and track record make it ideally positioned to capitalise on this opportunity, informed Shaw.