The Main Ingredient Of Tamiflu Hard To Come By
Star Anise is a spice that originates in Southern China, and is the base ingredient for the anti-viral drug, Oseltamivir or generic tamiflu. This spice is made from the fruit of the star anise tree and is also used in Asian cooking, herbal medicines, and to produce the liqueur called pastis.
Because Oseltamivir is the primary drug used to fight a global pandemic of the swine flu, the demand for this medication has grown rapidly over the past several months. Star Anise contains the compound called shikimic acid, which is used to create Oseltamivir. The availability of Star Anise is limited, meaning that the supply of generic tamiflu is constrained as well.
The price of shikimic acid has climbed drastically with the increased demand for Oseltamivir. Originally costing $40 per kilogram, it is now priced at 10 times that amount at over $400 per kilogram.
The manufacturer of Tamiflu, Roche, has been asked by competing companies to allow their production of the drug. However, even if Roche gave in to the mounting pressure and granted permission, the supply of generic tamiflu would be limited to the finite supply of Star Anise, unless an alternative was available.
A professor at Michigan State University has developed an alternate method to create the primary material to create Oseltamivir, called shikimic acid, which does not require Star Anise. Using this method, the professor claims that he can make large amounts of generic tamiflu available and has started his own company to manufacture this drug.
In response to the anticipated demand for generic tamiflu, over 100 companies have applied for licenses from Roche, the manufacturer who holds the patent. Other manufacturers around the world have decided to proceed with manufacturing this drug without waiting for the approval from Roche, although company officials from Roche believe this may be a difficult task to accomplish.
Because the procedure to create Oseltamivir is complex and requires ten different stages, Roche has stated that a new manufacturer of this drug would need a minimum of two or three years to begin production of generic tamiflu. After securing a supply of raw materials, the process needs up to eight months to complete. Some of these stages of production are dangerous, as they require sodium azide, a chemical that is also used to create the explosive component in automobile air bags.
While other drug manufacturers agree that manufacture of Oseltamivir is difficult, they do not feel this is an obstacle they cannot overcome. Cipla, a large Indian drug manufacturer that plans to produce Oseltamivir, currently uses sodium azide in its manufacturing process for two other drugs it produces, AZT (which is used to fight AIDS) and another drug used to combat epilepsy. Within a few months, Cipla plans to have enough Oseltamivir on hand to treat up to 200,000 people.
Headquartered in Basel, Switzerland, Roche will be increasing its production of Tamiflu by eight to ten times its 2003 production levels. The inventor of Tamiflu, Ernie Prisbe, who later licensed its production to Roche, agreed that the production process for Oseltamivir is complex and time consuming. He stated that the manufacture of Oseltamivir requires 12 steps, and each step in the process requires between four and six weeks to complete.
When manufacturing a small quantity of generic tamiflu in a laboratory, the process can be completed in a short period of time. In Taiwan, the National Health Research Institute created Oseltamivir within eighteen days. However, to produce this drug on a mass scale, a much longer time frame is required.