Sept. 29 (Bloomberg) -- Biocon Ltd., India’s biggest biotechnology company, plans to begin commercial production of an insulin pill within 18 months, giving millions of diabetes sufferers a new way of controlling blood-sugar.

The orally administered hormone is in the final of three stages of patient studies that drugs usually require for regulatory approval, Biocon Managing Director Kiran Mazumdar- Shaw said in an interview in Kuala Lumpur today.

If successful, the tablet would help the Bangalore-based company tap a global insulin market which New York-based MarketResearch.com predicts will grow 15 percent annually through 2010. Pen-like injections, syringes and pumps dominate the market, and needle-free methods of delivering the drug have proven elusive. Pfizer Inc. withdrew Exubera, an inhaled product, in 2007 after it failed to catch on with doctors and patients.

“This is a product that we see to be a game-changer,” Mazumdar-Shaw, 53, said. “It has huge potential and certainly can be a multibillion dollar blockbuster.”

Mazumdar-Shaw, who is in the Malaysian capital for the three-day Forbes Global CEO Conference, said she expects to start selling insulin products in Europe and U.S. within the next 18 to 24 months.

In an October 2007 interview, Mazumdar-Shaw said the company was in talks with “many” foreign companies about selling the rights to the insulin pill. Biocon will look again for marketing partners after the results of phase-3 studies are reported in the first quarter of next year, she said.

‘Lot of Skepticism’

“There is a lot of skepticism about whether these kinds of products really do the job,” Mazumdar-Shaw said. “We are confident.”

Of the estimated 246 million people affected by diabetes worldwide, about 5 percent to 10 percent have the type 1 form that’s marked by the inability to produce insulin, a hormone that turns blood sugar into energy, according to the International Diabetes Federation. India is the worst-affected by diabetes, with about 41 million sufferers, followed by China and the U.S.

Biocon, which sells conventionally administered insulin in India, aims to increase its share of the domestic market to 50 percent from 15 percent in five years, Mazumdar-Shaw said.

Biocon shares, which have more than doubled this year, rose as much as 2.5 percent to 263.8 rupees on the Mumbai Stock Exchange. They added 4.8 rupees to 262.25 rupees at 12:08 p.m. Mumbai time. Mazumdar-Shaw is Biocon’s biggest shareholder, with almost 40 percent of the stock, according to a June 30 filing.

To contact the reporter on this story: Soraya Permatasari in Kuala Lumpur at soraya@bloomberg.net

Last Updated: September 29, 2009 03:11 EDT