Wednesday, November 02, 2005

Are the sources of shikimic acid adequate for the production of oseltamivir?

This is from the transcript of the October 12, 2005 broadcast of Lou Dobbs Tonight.

KITTY PILGRIM, CNN CORRESPONDENT (voice over): Thirty-four thousand prescriptions of the flu drug Tamiflu were filled last week. Last year at this time it was only 4,000. Tamiflu is one of the few drugs that experts think may be helpful in treating bird flu, or avian flu, if a human-to-human pandemic occurs.

Tamiflu is made by Roche, a European company. But up until now, the active ingredient of the drug, oseltamivir, is found in a plant, the star anise. A primary source of that plant is China.

NICK TURLAND, MISSOURI BOTANICAL GARDEN: It's only known from China as a wild plant. It's quite restricted in southwestern China near the Vietnam border. It probably gets over into northeastern Vietnam as well.

PILGRIM: Scientific papers from Roche show the process, from Chinese star anise, to shikimic acid, to oseltamivir, to capsules of Tamiflu.

ELIZABETH PRESCOTT, BIOSECURITY ANALYST, EURASIA GROUP: If we were to see high demand for this chemical compound, there might be some disruption of delivery of the active ingredient, and therefore have an impact on ultimately delivering Tamiflu even at the maximum manufacturing capability that we currently have, which is still not sufficient.

PILGRIM: Roche says the ingredient is also being synthetically produced in a new manufacturing process to supplement natural supply. A Tamiflu supply chain is expected to be approved in the U.S. this year.

Medical experts say Roche has significant production problems that may limit how much or how easily the ingredient can be made synthetically. The Food and Drug Administration says they have no comment on the supply of the active ingredient of Tamiflu, the information is a trade secret.

1 comment:

Anonymous said...

Roche does not produce the raw material, shikimic acid via a "synthetic process". It is produced by a bacterial fermentation, like many amino acids and other metabolites.