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Biocon launches new-generation human insulin

Wednesday, 10 November 2004, 00:00 Hrs
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BANGALORE: Biocon Ltd, one of India's leading biotechnology firms, Wednesday launched a new-generation insulin product branded Insugen.

Claimed to be the world's first recombinant human insulin (r-DNA), Insugen will be available in 10 ml vials -- 40 international units per ml (iu/ml) -- at an introductory price of 126 in the domestic market.

Announcing the launch here, Biocon chairman and managing director Kiran Mazumdar Shaw told reporters the company was the first Indian insulin producer to submit a drug master file (DMF) to the US Food and Drug Administration (USFDA).

"Insugen is the country's most clinically validated r-DNA insulin produced in Asia's largest human insulin plant, set up on the outskirts of Bangalore at an investment of 500 million," Shaw said.

The company's research facility spent about 750 million over four years to develop the product in three formulations for treating diabetes.

Unlike the conventional animal insulin, Insugen is produced from human gene by cloning it with a yeast, Pichia pastoris.

"Our product will be more effective for type-1 or type-II diabetics as its administration will be less painful," Shaw disclosed.

During the first phase of launch, the product will be introduced in 10 states -- Andhra Pradesh, Delhi, Goa, Gujarat, Karnataka, Kerala, Maharashtra, Punjab, Rajasthan and Tamil Nadu.

"Insugen launch marks a milestone in Biocon's foray into protein therapeutics. Our focus areas are diabetes and oncology. With this product, we reiterate our commitment to provide biotechnology solutions for worldwide diseases," Shaw stated.

Prior to the launch, the company had conducted a clinical trial on 450 patients as against the norm of a sample size of 360 patients.

According to the World Health Organisation (WHO), India accounts for 25 percent (32 million) of the world's diabetic population (128 million). WHO estimates the global diabetic population to increase to 570 million by 2025, with the world's largest diabetic population residing in India.

"Although diabetes cannot be cured, it can be effectively treated or controlled. The aim of our diabetes treatment is to try and maintain blood glucose level as close to normal as possible," Shaw said.

The company also plans to launch Insugen globally, beginning with Middle East, Southeast Asia and South America next year.

"Insugen will enter the European and the US markets after we develop sophisticated devices likes pens and painless injections.

"We have also entered into a marketing tie-up with the Britain-based Bristol-Mayers Squibb for exporting Insugen in bulk form," said Biocon marketing president Ajay Bhardwaj.

The Indian market for human insulin is estimated to grow at 15 percent annually. The current market size is 2.2 billion with four major players (Novo Nordisk, Eli Lilly, Aventis and Wockhardt) are competing for a share of the growing pie.
Source: IANS
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