Tamiflu Update - Who’s Going to Produce It?
It wasn’t so long ago that Tamiflu producer Roche Holding was insisting it would not license outside companies to produce the drug. One reason cited was the complexity of production – a 10-stage, one-year process that included extracting shikimic acid from the seeds of the star anise spice, and then converting it into a drug. A Roche spokesperson said it would take other pharmaceuticals companies three years to gain the ability to replicate this process.
What a difference a few weeks makes. Now it seems that companies in numerous countries not only plan to launch production, but they believe they can rapidly turn out fairly large quantities of the drug. And it seems they might gain Roche’s permission.
This article is intended as a round-up of what’s happening.
Firstly, Roche itself. On October 18th it announced its readiness to “enter discussions with governments and other manufacturers on the production of Tamiflu for emergency pandemic use.” The company has also said it is boosting its own production.
Since then –
On October 20th two US senators said that Roche had agreed to hold talks with four other drugs companies, Teva Pharmaceutical Industries, Barr Pharmaceuticals, Mylan Laboratories and Ranbaxy Laboratories, with a view to allowing them to launch generic production of Tamiflu.
On October 21st India’s second largest drugs company, Cipla, was reported as stating it expected to be able to produce 50,000 doses of Tamiflu by January 2006.
On October 24th it was reported that two Taiwanese manufacturers had already made small quantities of Tamiflu, and on October 31st the Taiwanese Department of Health submitted an application to Roche for local manufacture of Tamiflu.
A report on November 2nd said that China's largest drugmaker Shanghai Pharmaceutical was holding talks with Roche about local Tamiflu production. Another report on the same day said Malaysia was considering initiating its own local production of the drug. And the Korea Herald reported that 10 Korean pharmaceuticals companies plan to talk with Roche about production in Korea.
On November 4th officials of the Vietnamese Ministry of Health said they were planning talks with Roche about local production of Tamiflu. Vietnam is the worst-affected of all countries that have been hit by bird flu.
On November 5th the Thai Government Pharmaceutical Organization announced plans to manufacture Tamiflu, which is not patented in Thailand. It expected the first batch to be ready by January.
Stay tuned. This is a story that is going to run and run.