India's Cipla says ready to make generic version of anti-bird flu drug

by AFX Asia (Focus),
The FT Online

Bombay, 20 Oct 2005 - Generic drug maker Cipla Ltd, the first to make cheap AIDS drugs, is ready to try the same move with a cut-rate version of the anti-viral Tamiflu bird flu medicine, a company executive said.

The firm said it is set to make 750 kilograms of a generic version of the drug per month and sell it globally despite a patent held by Swiss-based Roche.

Roche has been under growing pressure to allow other companies to make the drug, which is in short supply, in the face of warnings by the World Health Organization (WHO) of a possible pandemic of the fatal H5N1 bird-flu virus.

"We are doing generic drugs for treating bird flu," Amar Lula, joint managing director of Cipla, told Agence France-Presse. "We have no deal with Roche on the product, but could explore a tie-up."

Analysts said Cipla is pursuing the same strategy it used as a leader in the manufacturing of generic, low-cost copies of anti-retroviral drugs used to treat HIV/AIDS in Africa.

"There is a lot of stockpiling in the developed countries and that is where the money is, but Cipla will not gain much in the beginning," a pharmaceutical analyst said on condition of anonymity.

He added that Cipla is looking at the developing world as its primary market.

Roche said earlier this week it may grant sub-licenses to governments or private companies to manufacture, or collaborate in manufacturing, Tamiflu just days after it signalled a reluctance to loosen its grip on an exclusive license.

In March, India's parliament passed a patent bill that prohibits domestic firms from making low-cost generic versions of patented drugs. The law replaced legislation allowing the copying of patented products using a different manufacturing process.

The law drew concern from public health professionals because India, one of the world's biggest producers of generic drugs, is among the cheapest suppliers to poor countries.

The country is the fourth-largest producer of medicines by volume, but only 13th by value -- an indication of the relative cheapness of its products, according to Medecins Sans Frontieres.

Industry sources said for that reason Cipla may be trying to get Roche to allow it to manufacture the drug, to help build stockpiles.

"Cipla will initially focus on the unregulated markets as the patented markets like US and Europe would be difficult to penetrate," said Rohit Bhatt, a pharmaceutical analyst at brokerage Batliwala and Karani.

The spread of the human H5N1 strain of avian flu in birds migrating from Asia to Europe in recent weeks has prompted a rush for the drug worldwide.

So far, it appears that all human cases of bird flu contracted the disease from poultry, and not from other people. Cases of people infected by the virus have occurred in Cambodia, Indonesia, Thailand and Vietnam.

Roche is aiming to raise output eight to tenfold over 2003 levels within 18 months on its own.

But public health bodies such as the WHO have said there is a massive shortage of the drug at present, if the virus starts spreading between humans and causes a pandemic which could kill millions.

"The threat of a pandemic is very real. It is no longer a question of if it will occur. It is now only a question of when," said Samlee Plianbangchang, director for the organization's Southeast Asia office.

"Low-income countries, which are ill equipped to handle a pandemic, are likely to be the worst affected."

The Indian government earlier this month said that there were no signs of a bird flu outbreak in the country, but said it is on the alert for unusual numbers of bird deaths and is in touch with state governments on the issue.

Its announcement came a day after the WHO issued a warning to India and other countries in Asia about the possibility of a heavy toll, if bird flu were to spark a worldwide epidemic.

About the The FT Online

For More Information Please Contact