International Herald Tribune

Indian drug maker innovates in diabetes trials

By Mrinalini Datta and Michelle Fay Cortez

September 26, 2006

NEW DELHI Dr. Reddy's Laboratories, which built a $546 million global business from its base in India by copying medicines, said it could sell its own diabetes drug within five years to challenge brand-name producers.

Dr. Reddy's, one of the largest Indian drug makers, began researching new drugs in 1993. The first candidate to emerge from its own labs will enter the final stage of human testing next year and could be available by 2011, according to the company's chairman, K. Anji Reddy.

Developing its own treatments would help bolster annual revenue, which is equivalent to less than three weeks of sales for Pfizer's cholesterol treatment Lipitor, the world's best-selling drug.

Ranbaxy, the largest Indian drug maker, is also using profit from the booming market for generic medicines to make its own discoveries.

"By 2010, maximum by 2011, we should see our own drug in the world market," Reddy said in an interview Thursday from the south Indian city of Hyderabad, where he founded the company in 1984.

Dr. Reddy's invested $48 million during the year ended March 31 on research and development, including about $20 million to find new drugs.

In the last decade, it created balaglitazone to sensitize the body's ability to use insulin. The molecule is a so-called glitazone, a new class of treatment for sufferers of type 2 diabetes.

Global sales of branded prescription drugs for diabetes will grow 15 percent a year through 2010, the fastest pace of any drug category, Lehman Brothers said in a report this month. It estimated that the category would be worth $33.1 billion by the end of the decade from $15.9 billion in 2005.

Biocon, the biggest Indian biotechnology company, is developing an orally administered insulin to treat type 1 diabetes. The drug candidate is in the first of three phases of clinical trials.

If Dr. Reddy's is successful, it would be the first Indian company to develop a novel treatment for diabetes, a disease the World Health Organization predicts will afflict 79 million people in the South Asian country by 2030. The health agency estimated that there were 32 million sufferers six years ago.

For a low-income Indian family with an adult with diabetes, as much as a quarter of family income can go to diabetes care, according to the WHO. Worldwide, about 230 million people have diabetes and the number could exceed 350 million by 2025, according to the International Diabetes Federation.

Avandia, a glitazone drug made by Glaxo, generated sales of $870 million in the second quarter and was the London-based drug maker's second-best seller. Takeda Pharmaceutical of Japan sells about $2 billion worldwide a year of its glitazone, Actos.

Drugs like Avandia and Actos are desirable because they target the body's rejection of insulin, the hormone used to convert blood sugar to energy, said Christopher Saudek, director of the Johns Hopkins Diabetes Center and past president of the American Diabetes Association. Blocking the process leads to rising blood sugar levels, causing complications and destroying organs like the heart and kidneys.

"The appeal of these drugs is that they act directly on insulin resistance, which is considered to be the prime cause of type 2 diabetes," Saudek said Friday in a telephone interview. "They are also quite free of side effects. They are new arrows in the quiver, a new option in managing type 2 diabetes."

Indian drug makers, who for three decades were allowed to copy medicines by using a different manufacturing process, or reverse-engineering, are trying to develop their own medicines after the country tightened its patent laws starting Jan. 1 last year to bar the copying of medicines patented after 1995. Dr. Reddy's is developing balaglitazone with Rheoscience, of Denmark, which is funding the cost of the third phase of clinical trials, the costliest stage.

NEW DELHI Dr. Reddy's Laboratories, which built a $546 million global business from its base in India by copying medicines, said it could sell its own diabetes drug within five years to challenge brand-name producers.

Dr. Reddy's, one of the largest Indian drug makers, began researching new drugs in 1993. The first candidate to emerge from its own labs will enter the final stage of human testing next year and could be available by 2011, according to the company's chairman, K. Anji Reddy.

Developing its own treatments would help bolster annual revenue, which is equivalent to less than three weeks of sales for Pfizer's cholesterol treatment Lipitor, the world's best-selling drug. Ranbaxy, the largest Indian drug maker, is also using profit from the booming market for generic medicines to make its own discoveries.

"By 2010, maximum by 2011, we should see our own drug in the world market," Reddy said in an interview Thursday from the south Indian city of Hyderabad, where he founded the company in 1984.

Dr. Reddy's invested $48 million during the year ended March 31 on research and development, including about $20 million to find new drugs.

In the last decade, it created balaglitazone to sensitize the body's ability to use insulin. The molecule is a so-called glitazone, a new class of treatment for sufferers of type 2 diabetes.

Global sales of branded prescription drugs for diabetes will grow 15 percent a year through 2010, the fastest pace of any drug category, Lehman Brothers said in a report this month. It estimated that the category would be worth $33.1 billion by the end of the decade from $15.9 billion in 2005.

Biocon, the biggest Indian biotechnology company, is developing an orally administered insulin to treat type 1 diabetes. The drug candidate is in the first of three phases of clinical trials.

If Dr. Reddy's is successful, it would be the first Indian company to develop a novel treatment for diabetes, a disease the World Health Organization predicts will afflict 79 million people in the South Asian country by 2030. The health agency estimated that there were 32 million sufferers six years ago.

For a low-income Indian family with an adult with diabetes, as much as a quarter of family income can go to diabetes care, according to the WHO. Worldwide, about 230 million people have diabetes and the number could exceed 350 million by 2025, according to the International Diabetes Federation.

Avandia, a glitazone drug made by Glaxo, generated sales of $870 million in the second quarter and was the London-based drug maker's second-best seller. Takeda Pharmaceutical of Japan sells about $2 billion worldwide a year of its glitazone, Actos.

Drugs like Avandia and Actos are desirable because they target the body's rejection of insulin, the hormone used to convert blood sugar to energy, said Christopher Saudek, director of the Johns Hopkins Diabetes Center and past president of the American Diabetes Association. Blocking the process leads to rising blood sugar levels, causing complications and destroying organs like the heart and kidneys.

"The appeal of these drugs is that they act directly on insulin resistance, which is considered to be the prime cause of type 2 diabetes," Saudek said Friday in a telephone interview. "They are also quite free of side effects. They are new arrows in the quiver, a new option in managing type 2 diabetes."

Indian drug makers, who for three decades were allowed to copy medicines by using a different manufacturing process, or reverse-engineering, are trying to develop their own medicines after the country tightened its patent laws starting Jan. 1 last year to bar the copying of medicines patented after 1995. Dr. Reddy's is developing balaglitazone with Rheoscience, of Denmark, which is funding the cost of the third phase of clinical trials, the costliest stage.

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