– Ranbaxy eyes scaled-up Tamiflu output

well.. I was a bit late! hmmm.. .here Ranbaxy is at it already!

Indian generic drugmaker Ranbaxy Laboratories Ltd. (RANB.BO) has already worked out how to make a copycat version of Roche Holding AG’s (ROG.VX) drug Tamiflu, in short supply as governments build bird flu stockpiles, and could scale up production by mid-2006.

Ranbaxy’s Chief Executive Brian Tempest told the Reuters Health Summit on Monday that the company was currently talking to Switzerland’s Roche about producing the drug, which the Indian drugmaker has so far only produced at a laboratory scale.

“We did the chemistry some time ago,” Tempest said. “By the time we are through with this it would be the mid-part of next year.”

Tempest, speaking at Reuters New York offices, said it was too early to talk about potential production capacity for the drug but he noted Ranbaxy was used to supplying large quantities of low-priced generic medicines to markets around the world.

Governments are scrambling to stockpile the drug, which has been recommended by the
World Health Organization as the most effective treatment available in the event of a flu pandemic.

Faced with huge demand, the Swiss drugmaker has come under pressure from generic drug companies, developing nations and the United States to increase production.

Roche said earlier on Monday it would ramp up production of the antiviral drug to 300 million treatments by 2007, equivalent to a tenfold increase in capacity over 2004 levels.

It also said that it was in early talks with eight companies, both generic drugmakers and large pharmaceuticals manufacturers, as well as a number of governments.

Tempest confirmed that Ranbaxy was one of the eight.

“On the point of view of our discussions with Roche we have met with them and we are waiting to hear back from them,” he said.

Tempest said the firm was confident it had the scientific know-how to produce generic Tamiflu in large volume, despite Roche’s insistence that the medicine is hard to manufacture.

He said that availability of the raw material which forms the basis of Tamiflu would be the factor which limited overall output, rather than production capacity.

The Chinese herb star anise is currently used as the source of shikimic acid, the starting point in the 10-step process which Roche says is necessary to produce the drug, known generically as oseltamivir.

“The capacities for bigger volumes will be limited by the availability of this herb,” Tempest said.

Britain’s GlaxoSmithKline Plc (GSK.L) also makes an inhaled drug in the same class as Tamiflu, called Relenza, but Tempest said that the Indian company had no plans to make a copycat version of that.

Roche said it hoped to select potential partners from the companies and governments that it is talking to for more detailed discussions by the end of November.

… read more