The Hindu Business Line : Biocon in insulin supply deal with Bristol-Myers

BIOCON Ltd has entered into a nine-year export contract with US major Bristol-Myers Squibb Co to supply the bulk form of its recombinant human insulin.

Biocon hopes to launch its own insulin brand, Insugen, during the second quarter of this fiscal.

The drug has completed phase 3 clinical trials and is awaiting the Genetic Engineering Approval Committee's (GEAC) approval, said Ms Kiran Mazumdar-Shaw, CMD.

She admitted that the domestic launch of its insulin version had been delayed by a few of months in the wake of regulatory issues that were being sorted out in the case of Shanta Biotechnics's recombinant streptokinase drug.

The industry expected the Mashelkar Task Force to ensure that the GEAC, a Ministry of Environment and Forests arm, did not have to intervene in clinical trials for genetically engineered products as it was a matter for the DCGI, she added.

Biocon was the first Indian company to file a drug master file with the USFDA on the recombinant human insulin.

The product would be a major driver of its growth, along with immunosuppressants, statins and branded formulations.

The USFDA approval for its cholesterol-lowering statins and pioglitazone manufacturing plant would give the company access to the $6-billion market that would go off-patent in the US in 2006, she said.

Biocon is already exporting lovastatin to the US and simvastatin to Europe.

The trials for the head and neck cancer drug through its Cuban joint venture, Biocon Biopharmaceuticals, would be taken up around July at two centres in Bangalore.

During 2003-04, Biocon filed 88 PCT patents, among the largest set filed by Indian corporates.

It added 270 employees last year and plans to take in 400-500 more employees this year.

Ms Mazumdar-Shaw, who heads the CII Biotechnology Task Force, hopes that the Government would soon start the Rs 200-crore incubation fund as suggested by the biotech industry.

Revenue touches Rs 549 cr; to pay Re 1

BIOCON Ltd's total income for 2003-04 has touched Rs 549.3 crore, a jump of 94 per cent from Rs 283.3 crore in 2002-03.

The Bangalore-based biotechnology major, which came out with an IPO last month, saw its profit after tax (PAT) increase 219 per cent to Rs 138.6 crore from Rs 43.5 crore earlier, said Ms Kiran Mazumdar-Shaw, CMD.

"The outlook for the year ahead is very positive. We expect substantial growth to be delivered by sales of pravastatin to Europe and from our new products, insulin, immunosuppressants and branded formulations."

She added: "All our key businesses, namely statins, enzymes and research services demonstrated exceptional growth. We expect our current expansion programme to deliver substantial growth in the near future."

Operating profits moved up 142 per cent to Rs 179.5 crore (Rs 74.1 crore).

Operating margins were higher by 654 basis points at 33 per cent for the year while net margins grew to 25 per cent.

The EPS for the year was Rs 16. The board has recommended a dividend of 20 per cent or Re 1 per share.

Ms Mazumdar-Shaw said that the revenue growth was led by a strong performance in the US and European markets, where exports grew 151 cent over the previous year.

Some 79 per cent of the operating revenues came from biopharmaceuticals, which showed sales of Rs 435.4 crore or a growth of 117 per cent. Custom and clinical research contributed 38.8 crore.

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