By Arun Kumar, IANS
Washington : US drug makers are making countries like India and China the testing ground for new medicines to shorten the time it takes for pharmaceutical products to enter the American market.
In a period of escalating costs at home, conducting clinical trials abroad allows drug companies to keep research costs low, a report in the Washington Times said citing drug industry experts.
Also, because of large populations of potential patients in India, China and other Asian countries, drug makers can gather data more quickly to expedite the drug-approval process in the US, they said.
“There is no question, clinical research is globalising,” said David Lepay, senior adviser for clinical science at the Food and Drug Administration (FDA) cited by the Times.
“It does indeed expedite the product-development process in the United States, that’s a positive public health benefit.”
It is too early to point to specific drugs that got their start abroad, but the foundations are being put in place. For example, GlaxoSmithKline just established a collaboration with India’s top six cancer centres and built a research and development centre in Shanghai, the Times said.
In 2006, large drug companies such as GlaxoSmithKline and Roche doubled research and development spending in India and China from the previous year to $2.2 billion.
The cost of conducting a clinical trial in China can cut in half the cost of that same trial in the US, according to a report by AT Kearney, a management-consulting firm. Cheaper labour and site fees contribute to the lower price tag.
The number of drug companies conducting clinical trials worldwide jumped from 956 in 1997 to nearly 1,800 last year, according to the Tufts Centre for the Study of Drug Development in Boston.
Ten years ago, 86 percent of all clinical trials were done in the US. Today, 30 percent of clinical trials are done in countries outside the US and Europe, and only 57 percent are done in the US.
Meanwhile, the FDA is taking steps to increase its drug-approval rate. The total number of blockbuster drugs approved by the FDA is expected to rise from 94 in 2005 to 112 in 2007, IMS Health estimated.
Potential blockbusters that are expected to debut next year include Johnson & Johnson’s paliperidone for schizophrenia, Wyeth’s desvenlafaxine for depression and Novartis’ Galvus for diabetes.
But drugs will reach the US market faster if the trend toward more overseas clinical trials continues, drug industry experts say.
“This trend will result in more drugs available to US consumers faster,” said Linda Bannister, a financial analyst for Edward Jones.
Foreign drug makers are out in front of US drug companies in tapping into the immense patient populations in overseas countries, according to drug industry experts.
In addition to the efforts of Britain’s GlaxoSmithKline and Switzerland’s Roche, AstraZeneca in England and Novartis of Switzerland have announced plans to spend $100 million on pharmaceutical research in China.
With $29 billion worth of drug patents set to expire in the next two years and $160 billion worth by 2015, US drug companies are fast on the heels of their foreign competitors to fill their product pipelines. Eli Lilly, in Indiana, recently announced that it would spend $300 million in China over the next five years.
The Washington Times quoted Tony Farino, leader of US Pharmaceuticals and Life Sciences Advisory Services at PricewaterhouseCoopers, as saying: “US companies will want a hold out there for future growth opportunities. US markets continue to be important, but Asian markets are rapidly becoming more important because there is a tremendous amount of people with chronic conditions that are not on medication.