India's drug makers no longer content to be copycats

Posted AtInternational Herald Tribune

Four years ago, Anji Reddy came tantalizingly close to realizing his life's ambition: discovering a blockbuster drug. In late 2001, Dr. Reddy's Laboratories, the company founded in 1984 by the Indian chemist-turned-entrepreneur, had a promising new compound that would treat diabetes in obese people by simultaneously lowering glucose and lipid levels in the body.

In July 2002, the dream came crashing down. The Danish company Novo Nordisk, which had licensed the compound from Dr. Reddy's to conduct clinical trials, aborted the project at the penultimate stage of the U.S. approval process when laboratory rodents developed bladder cancer.

With that setback, it appeared that Dr. Reddy's, which is listed in Mumbai and New York, was doomed to remain a "copycat," the Western media's less-than-flattering label for Indian drug makers.

Indian imitators are adept at making generic copies of branded drugs. According to Goldman Sachs Group, Indian companies filed a quarter of applications for licenses to sell duplicate versions of approved drugs in the United States last year.

It is easy to figure why. Universities in India annually graduate 12,000 Ph.D.s in chemistry, six times as many as in the United States. Thanks to an abundant supply and a reasonable cost of living, organic chemists in India come for a third of what they would cost in most developed countries.

Original research, by contrast, requires more than cheap chemists, Bunsen burners and a battery of copyright lawyers. Finding a blockbuster means spending 10 years or more sifting between 5,000 and 10,000 compounds. And even then, after sinking $800 million in the project, success is not guaranteed.

In 2002, Ranbaxy, India's biggest generic drug maker, licensed to Germany's Schwarz a prostate drug it was hoping would do great things for the company. Schwarz halted development work on the compound in the second stage of clinical trials in November of last year.

It is not surprising then that only a third of Indian drug makers' paltry $170 million research budget is dedicated to so-called new chemical entities, according to Goldman Sachs.

That is going to change rapidly because of what Plato said about necessity being the mother of invention. The need in this case is coming from the increasing uncertainty of the generics business.

The transformation, which is already under way, presents a good opportunity for investors with a strong appetite for risk. In the past two years, Ranbaxy and Dr. Reddy's have been the worst performers on the 30-company Mumbai stock exchange Sensitive Index, losing more than a quarter of their values.

But the pessimism may be nearing its end. In the past month, Dr. Reddy's shares have risen 10 percent, while Ranbaxy stock has gone up 7.5 percent, without a whiff of good news about the generics business.

Dr. Reddy's has not overturned a blockbuster patent in the United States since it successfully challenged Eli Lilly's best-selling antidepressant, Prozac.

That was in 2001.

Being the first to knock down a patented drug gives the challenger a six-month window to sell its copy exclusively in the world's biggest pharmaceutical market. Once other imitators come in, prices slump so rapidly that it gets tough to make money even with a high market share.

Ranbaxy has 19 molecules in which it has been the first to file patent challenges. As much as 57 percent of this $22.7 billion pipeline is under litigation, the company's chief executive, Brian Tempest, told investors this month.

A new, more stringent patent law that came into force this year in India has added to the urgency for homegrown drug companies to start inventing.

Several global drug companies are now expected to invest in their own research facilities in India, something they have been reluctant to do in a lax copyright regime.

That would push up wages for chemists and put further strain on research budgets of domestic companies that are still searching for their first blockbuster.

Ranbaxy now has an anti-malaria drug in the second stage of clinical trials. Mumbai-based Nicholas Piramal is testing a cancer drug in Canada. Reddy has his hopes pinned on a drug that might stop - even reverse - plaque formation in blood vessels.


If the treatment works, heart patients can get their clogged vessels cleaned up in weeks rather than the years it takes to do the same by giving up smoking and cheeseburgers.

Pfizer's 12,500 scientists had a budget of $7.9 billion in 2004, all paid for by revenue from just one drug - Lipitor, the cholesterol fighter. Reddy has a budget of $20 million and 300 chemists working for him in Atlanta and Hyderabad, the company's home base in southern India.

What makes Reddy think he stands a chance? "It's absolute nonsense," Reddy said, "to think that productivity in science is directly proportional to money."

Money, nonetheless, plays an important part. Dr. Reddy's has transferred four of its new chemical entities to Perlecan Pharma, a company it recently set up with initial equity of $52.5 million provided by the venture capital units of Citigroup and ICICI Bank, a major Indian lender.

The deal has reduced research costs for Dr. Reddy's, playing a part in boosting second-quarter profit by 72 percent.

Indian drug makers are getting both savvier and more serious about research. Being a copycat is losing its charm. Investors might do well to take notice.

With that setback, it appeared that Dr. Reddy's, which is listed in Mumbai and New York, was doomed to remain a "copycat," the Western media's less-than-flattering label for Indian drug makers.

Indian imitators are adept at making generic copies of branded drugs. According to Goldman Sachs Group, Indian companies filed a quarter of applications for licenses to sell duplicate versions of approved drugs in the United States last year.

It is easy to figure why. Universities in India annually graduate 12,000 Ph.D.s in chemistry, six times as many as in the United States. Thanks to an abundant supply and a reasonable cost of living, organic chemists in India come for a third of what they would cost in most developed countries.

Original research, by contrast, requires more than cheap chemists, Bunsen burners and a battery of copyright lawyers. Finding a blockbuster means spending 10 years or more sifting between 5,000 and 10,000 compounds. And even then, after sinking $800 million in the project, success is not guaranteed.

In 2002, Ranbaxy, India's biggest generic drug maker, licensed to Germany's Schwarz a prostate drug it was hoping would do great things for the company. Schwarz halted development work on the compound in the second stage of clinical trials in November of last year.

It is not surprising then that only a third of Indian drug makers' paltry $170 million research budget is dedicated to so-called new chemical entities, according to Goldman Sachs.

That is going to change rapidly because of what Plato said about necessity being the mother of invention. The need in this case is coming from the increasing uncertainty of the generics business.

The transformation, which is already under way, presents a good opportunity for investors with a strong appetite for risk. In the past two years, Ranbaxy and Dr. Reddy's have been the worst performers on the 30-company Mumbai stock exchange Sensitive Index, losing more than a quarter of their values.

But the pessimism may be nearing its end. In the past month, Dr. Reddy's shares have risen 10 percent, while Ranbaxy stock has gone up 7.5 percent, without a whiff of good news about the generics business.

Dr. Reddy's has not overturned a blockbuster patent in the United States since it successfully challenged Eli Lilly's best-selling antidepressant, Prozac.

That was in 2001.

Being the first to knock down a patented drug gives the challenger a six-month window to sell its copy exclusively in the world's biggest pharmaceutical market. Once other imitators come in, prices slump so rapidly that it gets tough to make money even with a high market share.

Ranbaxy has 19 molecules in which it has been the first to file patent challenges. As much as 57 percent of this $22.7 billion pipeline is under litigation, the company's chief executive, Brian Tempest, told investors this month.

A new, more stringent patent law that came into force this year in India has added to the urgency for homegrown drug companies to start inventing.

Several global drug companies are now expected to invest in their own research facilities in India, something they have been reluctant to do in a lax copyright regime.

That would push up wages for chemists and put further strain on research budgets of domestic companies that are still searching for their first blockbuster.

Ranbaxy now has an anti-malaria drug in the second stage of clinical trials. Mumbai-based Nicholas Piramal is testing a cancer drug in Canada. Reddy has his hopes pinned on a drug that might stop - even reverse - plaque formation in blood vessels.


If the treatment works, heart patients can get their clogged vessels cleaned up in weeks rather than the years it takes to do the same by giving up smoking and cheeseburgers.

Pfizer's 12,500 scientists had a budget of $7.9 billion in 2004, all paid for by revenue from just one drug - Lipitor, the cholesterol fighter. Reddy has a budget of $20 million and 300 chemists working for him in Atlanta and Hyderabad, the company's home base in southern India.

What makes Reddy think he stands a chance? "It's absolute nonsense," Reddy said, "to think that productivity in science is directly proportional to money."

Money, nonetheless, plays an important part. Dr. Reddy's has transferred four of its new chemical entities to Perlecan Pharma, a company it recently set up with initial equity of $52.5 million provided by the venture capital units of Citigroup and ICICI Bank, a major Indian lender.

The deal has reduced research costs for Dr. Reddy's, playing a part in boosting second-quarter profit by 72 percent.

Indian drug makers are getting both savvier and more serious about research. Being a copycat is losing its charm. Investors might do well to take notice.

November 28, 2005