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Governments worldwide should “wake up” about the threat of pandemic flu  

The Indian pharmaceutical company Cipla is first in the line to make generic Tamiflu, but India’s officials gesture despair at flu threat

(21 Oct 05)

The chairman of a company that holds one key to the protection of the developing world from pandemic flu is concerned about government inaction – and effect of new Indian patent law, which recognizes international intellectual property rights.

Pandemic flu will strike the world soon, perhaps through the evolution of the existing, virulent H5N1 strain of bird flu, which is now entering Europe and is on bird migration routes to East Africa. A human pandemic flu would have to be easily transmissible between people, and not too fatal, or a pandemic would fizzle out. If such a virus arises, it may well be an H5N1 strain.

One drug is most effective, if taken quickly – Roche’s Tamiflu. But supplies are limited and costs high, until Cipla and other companies announced they would prepare to make generic copies. To learn of the potential and the problems, RealHealthNews today interviewed Cipla’s Chairman and Managing Director, Y K Hamied.

Y K Hameid, Chairman and Managing Director, Cipla: About three months ago, just after the disastrous floods in Mumbai, I was talking with a senior Indian government official connected with the health ministry, and I asked him: ‘Suppose pandemic flu hits India tomorrow – what would the Indian government do?’. Would you like to know his response? He just threw his hands above his head and said not a word [a gesture of despair].

That had a big impact on me, because it’s a very serious problem.

Robert Walgate, Editor, RealHealthNews: We’ve been getting the same response from developing countries all around the world – Africa, Latin America, now Asia.

YKH: I would strongly suggest that governments wake up! The Indian government hasn’t yet made a statement. I would strongly suggest that they don’t grant the patent on Tamiflu. It hasn’t yet been granted, there are technicalities, just don’t grant it!

RW: How will you produce Tamiflu [or oseltamivir, to give its non-proprietary name]?

YKH: The techniques have been published for the last ten years; in the literature there are a number of methods. It’s not an easy synthesis, but our company is used to manufacturing difficult things – we do all the vincra alkaloids for cancer, a number of the drugs for HIV/AIDS, and they are not easy molecules. One of the steps in zidovudine for example uses sodium azide, and that’s the step that Roche said was dangerous and hazardous – we’ve been doing it for the last 14 years. It’s all chemistry.

RW: What about the source material? Don’t you need the seeds of the Chinese plant, star anise?

YKH: That is the problem. We as manufacturers are like tailors – we need the cloth. Then we can make it into a suit. To manufacture oseltamivir on a very very large scale, the bottleneck is this plant.

RW: Where will you get it from?

YKH: There’s only one source, China. That’s where Roche themselves get it.

RW: So if the source is limited…

YKH:…production will be limited, yes. That is why I made the statement to the New York Times last week that yes we’ll do it, but we are a small company, so what we are doing is to give an early warning signal. And already in the last week 11 companies have come forward saying yes we’re already planning to do it – and that gives me tremendous satisfaction!

RW: Why?

YKH: Because no one company can solve the problem. Twelve heads are better than one! And other companies have their own sources of star anise, and Roche has developed a fermentation method. So good luck to them!

RW: New Scientist says this week that your target is a million ten-capsule courses by next July. Is that right?

YKH: That would be an outside target. If we could do that, that would be fantastic.

RW: So what would be more realistic?

YKH: I can’t tell you today. Wait until next month, when we start the whole procedure.

RW: What about the Indian patent law? Doesn’t that restrict you?

YKH: Roche doesn’t have the patent. It belongs to Gilead. [Roche Holdings is the exclusive licensee.] And it’s not been granted in India. And we may challenge it because of certain technicalities. So legally as of today I can produce the drug in India. Until the patent is granted.

RW: There’s also the Doha Declaration of the World Trade Organization, allowing a government to issue a compulsory license if there is an overwhelming public health need.

YKH: That’s right. If any country declares a compulsory license, they are at liberty to buy from whomever they like.

RW: I thought they were at liberty to produce in their own country, but not to buy from abroad.

KH: No. And to buy. No two ways about it.


Roche already manufacturing Tamiflu by “fermentation”

Roche, the manufacturers of Tamiflu (oseltamivir), the most effective drug for H5N1 influenza, the kind now spreading through the world in birds, told RealHealthNews today that they are already manufacturing the starting material of the drug by fermentation of E. coli bacteria, as well as by extraction from the seeds of the Chinese plant star anise.

This could open the current bottleneck in production, which has seen Roche donate 3 million courses to the World Health Organization, when according to the UN’s pandemic flu supremo, David Nabarro, up to 150 million people could die in a pandemic. Roche say they plan to increase the amount of Tamiflu produced by this route, but would not reveal what proportion currently comes from E. coli, compared with star anise.

Roche’s E. coli produce the starting chemical – shikimic acid – by feeding a genetically modified E. coli excess glucose, a spokeswoman said.

oche is prepared to enter into production licences with other companies if their facilities and product are safe, a spokeswoman told RealHealthNews. The terms of these deals would vary case by case.



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