Thai Tamiflu To Hit Market By July

[george]

Thai tamiflu to hit market by July

BANGKOK: -- The first batch of the cheaper generic version of tamiflu, the antiviral drug believed to be the best defence against bird flu, is expected to hit the market by July.

The Government Pharmaceutical Organisation (GPO) which is responsible for producing the generic version in Thailand recently turned out about 200,000 capsules for pre-registration testing, Deputy Public Health Minister Anutin Charnvirakul said.

The next step was to get the drugs tested to study their effectiveness against the real tamiflu, he said. Only then can the drug be registered with the Food and Drug Administration and the GPO can start to produce the generic drug in mass quantities.

The GPO is capable of producing a million capsules of the drug for 100,000 people within 15 days and the agency could increase its production capacity up to three times if necessary, Anutin said.

"The drug could be sent to the area where it is needed within 24 hours in the event of rampant spread of the disease," he added.

The first lot of generic tamiflu produced by the GPO should come out in five months at a cost of Bt70 per capsule, he said, adding the drug would be branded as GPO-A-Flu.

Pisamorn Klinsuwan, the GPO's director of research and development, said Thailand was not required to seek permission from the drug's original producer, Switzerland's Roche Holding AG, because the company had not patented it in Thailand.

The GPO purchased the oseltamivir's precursor, Shikimic acid synthesised from the Chinese spice star anise which is the active ingredient of tamiflu, from India.

--The Nation 2006-02-10

[Prakanong2005]

"The next step was to get the drugs tested to study their effectiveness against the real tamiflu, he said. Only then can the drug be registered with the Food and Drug Administration and the GPO can start to produce the generic drug in mass quantities."

Hmmm having knowledge of some clinical Trials in Thailand this wil be interesting.

One reason why Thailand loses out a lot on trials is because it takes so long to get a study approved ie up to 9 months whereas in somewhere like Korea, Taiwan etc it can be as little as two weeks

This study would not have to go through some of the problems with candidate medicines being held up o long with customs they are useless I suppose as some items do.

Not being an expert on protocol design I would how they will design this particular study.

Surely they can not just randomise two cohorts with bird flu and give one the Tamiflu and the other the thai version!

This bit is absolute rubbish

"Pisamorn Klinsuwan, the GPO's director of research and development, said Thailand was not required to seek permission from the drug's original producer, Switzerland's Roche Holding AG, because the company had not patented it in Thailand."

As Thailand is a member of the WTO they are covered by the worldwide patents and if this guy does not know that he should resign immediately as I would not trust anything he says.

Having said that a country can get around patents withing the WTO by citing a Public Health get out clause.

This is what South Africa did with anti-retrovirals, Brazil the same I think and the USA threatend to do with Cipro during the anthrax scare.

If the guy had any knowledge of the situation he would have alluded to this

[solo siam]

Great, We will have thousands of people taking it as a preventative measure everytime a chicken with birdflu is found. Probably lose its effectiveness within the year.

I'm not really sure why they are releasing Tamiflu to the public, there hasnt been an outbreak of contageous bird flu yet, Why not sell it to governments only.

Think about it, I get prescribed anti-biotics if I go to the local pharmacy with even a headache, these guys are going to be dishing these out like smarties to anyone who has a fever and a chicken.

[Prakanong2005]

"I'm not really sure why they are releasing Tamiflu to the public, there hasnt been an outbreak of contageous bird flu yet, Why not sell it to governments only."

The real Tamiflu is quite hard to get hold of by the genral public now with roche at full capacity producing the drug for governements which are piling up with back orders.

There is some evidence from trials that Tamiflu is not effective against H5N1 but its needs much wider studies.

Its not H5N1 that it needs to be effective against but the mutant virus if it combines with a human strain but we will not know that till the time.

Plenty of vaccine trials going on for H5N1 vaccines - many of them only in phase 1 with phase 2 starting about mid-year.

Edited February 10, 2006 by Prakanong2005